“Risk matrix” example.
\r\n\t
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Accepting customer’s requirements also means fulfillment of legal requirements (e.g. laws, standards, regulations) [1, 2].
Risks management is a basic tool for demonstration of meeting the requirements in different areas of organization management (e.g. occupational health and safety, accidents prevention, critical infrastructure, dangerous substances transportation, environmental or financial requirements). Management of the organization often times is kind of “lost” while determining effective economical actions to be able to follow the required legal frameworks of a business environment or achieve its own and more difficult goals. Benefits of the decision-making process, their reliability and efficiency are determined by a risk assessment analysis, which is increased by improper applied processes, risk assessment methods and a measurements selection for their management [1, 3, 4].
ISO 31000:2009 standard allows us to globally understand the risks assessment versus “unwanted losses” on an integrated level of all the management activities. However, this integrated management requires specific processes and methods of the risks management, which is derived from the system/object properties, risks assessment goals and processes management level in the organization [3].
Risks assessment is a basic requirement of technical systems safety and occupational health and safety (OHS) management.
Human legal requirement is a basic for assessing the safety level at work by meeting the minimal requirements which is defined by Council directive 89/391/EEC (“Framework Directive”); on the introduction of measures to encourage improvements in the safety and health of workers at work.
The scope of this Directive is defined for employers and employees in all sectors of the productive and non-productive sphere [1].
The Directive defines general requirements for prevention for an employer, who is obliged to apply the general principles of the prevention when implementing the measures necessary to ensure the safety and health protection at work, including the information, education and organization of work and tools. These principles include [1]:
Exclusion of the hazard and the possible resulting risk.
Risk assessment that cannot be excluded, especially while selecting or using working tools, materials, substances and methods.
Implementation of the measures to eliminate hazards at the site of their occurrence.
Prioritization of collective protective measures against individual protective measures.
Planning and implementing a policy of the prevention through the safety working tools, technologies. methods, improvement of the working conditions with regard to working environment factors and through social measures.
The Directive application can be defined as follows:
It is applied to all public and private areas, such as industry, agriculture, commerce, services, education, culture, leisure, and so on.
It does not concern areas, where specific public services and activities are involved, e.g. military and police activities or civil protection activities that may conflict with its requirements.
A number of specific directives (see Figure 1) have been adopted to implement the requirements of this Directive as individual directives within the meaning of Article 16 (1) of Directive 89/391/EEC in the following order (1. e.g. first individual Council Directive, etc.):
89/654/EEC of 30th of November 1989 concerning the minimum safety and health requirements for the workplace.
2009/104/EC (original 89/655/EEC) of 16th of September 2009 on the minimum health and safety requirements regarding the use of work equipment by workers at work.
89/656/EEC of 30th of November 1989 concerning the minimum health and safety requirements for the use of personal protective equipment by workers at work.
90/269/EEC of 29th of May 1990 on the minimum health and safety requirements for the manual handling of loads, especially where is a risk of injury to the lumbar spine of workers.
90/270/EEC on minimum safety and health requirements for work with displaying units.
2004/37/EC of the European Parliament and of the Council of 29th of April 2004 on the protection of workers from the risks related to exposure to carcinogens and mutagens at work.
2000/54/EC of the European Parliament and of the Council of 18th of September 2000 on the protection of workers from risks related to exposure to biological hazards at work, which is a consolidated directive of the previous Directives.
92/57/EEC of 24th of June 1992 on the introduction of minimum safety and health requirements for temporary or site-changing buildings.
92/58/EEC of 24th of June 1992 on the minimum requirements for the provision of safety and health signs at work.
92/85/EEC of 19th of October 1992 on the introduction of measures to encourage improvements in the safety and health at work of pregnant workers and workers who have recently given birth or are breastfeeding.
92/91/EEC of 3rd of November 1992 on the minimum requirements for improving the safety and health protection of workers in the extractive industry.
92/104/EEC of 3rd December 1992 on the minimum requirements for improving the safety and health protection of workers on the ground and underground mining.
93/103/EC of 23rd of November 1993 concerning the minimum safety and health requirements for work on board fishing vessels.
98/24/EC of 7th of April 1998 on the protection of the health and safety of workers from the risks related to chemical factors at work.
1999/92/EC of the European Parliament and of the Council of 16th of December 1999 on minimum requirements for improving the safety and health protection of workers potentially at risk from explosive environment.
2002/44/EC of the European Parliament and of the Council of 25th of June 2002 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical factors (vibration).
2003/10/EC of the European Parliament and of the Council of 6th of February on minimum health and safety requirements regarding the exposure of workers to the risks arising from physical nuisance (noise).
Canceled Directive 2004/40/EC of the European Parliament and of the Council of 29th of April 2004 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical factors (electromagnetic fields), note: replaced by 20th Council Directive.
2006/25/EC of the European Parliament and of the Council of 5th of April 2006 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical factors (artificial optical radiation).
2004/35/EC of the European Parliament and of the Council of 18th of June 2013 on the minimum health and safety requirements regarding the exposure of workers to the risks arising from physical factors (electromagnetic fields).
Relation between commission directive 89/391/EEC and individual council directives in accordance with Article 16 (1) [1].
Other significant directives on OHS, but not issued as individual directives under Article 16 (1) The Health and Safety Directives can be classified as:
Commission Directive 2000/39/EC of 8th of June 2000, which establishes the first list of indicative occupational exposure limit values for the implementation of Council Directive 98/24/EC on the protection of the health and safety of workers from the risks related to chemical factors at work.
Commission Directive 2006/15/EC of 7th of February 2006, which establishes the second list of indicative occupational exposure limit values for the implementation of Council Directive 98/24/EC and amending Directives 91/322/EEC and 2000/39/EC.
Commission Directive 2009/161/EU of 17th of December 2009, which establishes the third list of indicative occupational exposure limit values for the implementation of Council Directive 98/24/EC and amending Commission Directive 2000/39/EC.
Directive 2009/148/EC of the European Parliament and of the Council of 30th of November 2009 on the protection of workers from the risks related to exposure to asbestos at work.
The Machinery Directive 2006/42/EC on the approximation of the laws for the Member States relating to machinery is intended especially for machinery suppliers. For the machinery operators, the rules required in accordance with Directive 2009/104/EC, which replaced Directive 89/655/EEC, the so-called “The second individual Directive within the meaning of Article 16 (1) of Directive 89/391/EEC on the minimum safety and health requirements for the use of working equipment by workers at work (Figure 2).
History of legislation on machinery safety and OHS.
The Machinery Directive covers the use of all technical equipment, including mobile and lifting equipment. These devices must be regularly inspected and maintained to ensure their readiness and security.
The objective of this directive is to increase the level of equipment safety, with an emphasis on the analysis of possible risks in their intended operation and maintenance at the design and construction stage of the equipment. Emphasis is also placed on the creation of metering points for monitoring the status of equipment by the methods of the technical diagnostics already at the stage of the project. This creates conditions to prevent the occurrence of breakdowns and possible accidents by defining a real technical state, the impact of which would have an obvious effect on the safety and health of the operator or public. An important aspect is a detailed description of the operational regulations requirements in the native language of the country, where the technical equipment is in operation. Then, there are created standardized procedures for informing the operator of the existing hazards and residual risks arising from the operation of these devices [1, 5].
In accordance with Annex I, 1 Machinery Directive is a manufacturer of a machine or a complex technical device obliged to define the hazards, that arise during the operation of the machine, to estimate the consequences of possible injury or damage to health as well as the probability of their occurrence, and then determine and asses risks in order to take measures to minimize them. This is also connected with an obligation to provide machine user relevant information on residual risks.
These requirements make activities of machinery designers, engineers, manufacturers and users of machinery (including maintenance requirements—item 1.6) conditional upon them. Relevant activities must be conducted in accordance with risk management rules.
The Integrated Safety Principle is defined in Annex I to the Machinery Directive in five steps, as follows:
Devices must be designed and constructed in such a way that they are adapted to their function and can be operated, set and maintained, so people who use them are not exposed to the risks under the foreseeable conditions, also taking into account their reasonably foreseeable wrong use (e.g. operator error).
When selecting the most appropriate solutions, the manufacturer or his authorized representative, must apply the following principles in the following order:
Eliminate or reduce risks as much as possible,
Take the necessary measures to protect against risks,
Inform users of the residual risks caused by the various shortcomings in the protective measures taken, notifying whether special training is required and determining any need to provide personal protective equipment.
When designing and constructing a machine device and when drawing up the instructions for use, the manufacturer or his authorized representative must assume not only the intended use of the machinery but also his reasonably foreseeable misuse.
Machine devices must be designed and constructed in such a way that include taking into account the limitations to which the operator is exposed as a result of the necessary or foreseeable use of personal protective equipment (PPE).
Machine devices must be supplied with all the necessary special equipment and accessories to enable them to be safely adjusted, maintained and used.
The objective of the taken measures must be exclusion of any risk for the machine life cycle, including the phases of transport, assembly, disassembly, decommissioning and disposal [5, 6, 7]!
The instruction manual must inform about residual risks, meaning that informs a user of the ways, in which the machine devices should not be used.
A risk (under the Machinery Directive) is defined as a combination of probability and severity of injury or injury to health that may result from a dangerous situation!
In the risk assessment in the field of OHS, there are usually used simple methods based on the causal model of the accident (hazard → hazard situation → initiation → harm → loss). These methods are usually combined according to their use in the individual steps of the risk assessment algorithm (Brainstorming, Check-list, Risk matrix [1, 2, 3]).
The basic risk assessment algorithm is a structured logical sequence of steps (Figure 3) [1]. It does not matter whether it is a project, process, technology, device or a provided service. The analyzed system/object must be broken down into individual elements as is required to fulfill a defined task (activity, function). Each element is evaluated separately in terms of the possibility of endangering the target role (function). The probability or frequency, with which this hazard situation may occur at the time considered (duration of action), is the basis for the risk assessment together with the assessment of the severity (consequence) for the target function. In the financial sector, the risk is also declared positively (as ISO 31000 also accepts the concepts of opportunities), while the analysis of technologies and work activities is assessed only in relation to negative consequences [3].
Basic algorithm for risk assessment and management.
Measures derived from the assessed risks are defined either by legislation (relevant directives for specific areas—hazards, such as work with display units, noise protection, vibration, etc.), or/and requirements resulting from the overall culture and the advancement of the organization’s management to reduce the risk value to the lowest level possible (risk acceptability level) [1, 8].
Normally, risk assessment for OHS in organizations uses a “Risk matrix” (see Table 1), which is based on an assessment of the probability and consequence of the analyzed hazard that is determined from work activities [1, 9]. Emphasis is placed on a simple form of an evaluation and risk assessment and its understanding by all involved parties (employees, third parties, etc.).
Consequence | Probability | ||
---|---|---|---|
Low | Medium | Almost certain | |
Insignificant | L | L | M |
Significant | L | M | H |
Catastrophic | M | H | H |
Risk level | L – low | M – medium | H – high |
“Risk matrix” example.
It is essential to apply appropriate tools and procedures to meet legislative requirements. These are evolving and changing in terms of requirements for risk assessment, risk management and health and safety management at work. They can be broken down as follows:
Canceled standard EN 1050 Machines Safety: Principles of risk assessment (1998- replaced by EN ISO 14121-1: 2007, nowadays canceled too).
IEC 60300-3-9 Reliability Management: Part 3, Section 9: Risk Analysis of Technical Systems (1995).
EN ISO 12100 Machines Safety: General principles of machine design; Risk Assessment and Reduction (2010), Consolidation of ISO 12100-1 and ISO 12000-2 requirements.
Canceled standard ISO 14121-1: Machines Safety: Risk Assessment. Part 1: Principles; TNI/ISO/TR 14121-2: Practical Guides and Examples (2007).
ISO 31000 Risk management—principles and implementation guides (2009).
ISO 31010 Risk management—risk assessment techniques (2009).
OHSAS 18001:2007: Occupational Health and Safety Management System—Requirements.
OHSAS 18002:2000: Occupational Health and Safety Management System—Implementation guide OHSAS 18001.
New standard ISO 45001:2017, which is used to transform and complement the requirements of OHSAS 18001 internationally.
The safety issues of machines and machine devices are devoted to a number of harmonized standards which have their hierarchy [1] (see Figure 4).
Hierarchy of standards for the machines and equipment safety.
Type A standards: safety standards, providing basic concepts and principles for design, construction and general considerations that can be applied to all machine devices. Basic safety standards of Type A include for example EN ISO 12100.
Type B standards: safety standards that mostly take care of only one safety aspect or one type of safety device that can be used for a larger amount of machines. They are divided into: Type B1 standards, which are related to individual safety aspects (e.g. safety distances, surface temperatures, noise, etc.) and Type B2 standards for the relevant safety devices (e.g. different shields, pressure sensitive devices, two-hand control device, locking device, etc.).
Type C standards: safety standards for machines that define detailed safety requirements for a particular machine type or group of machines. They refer to related Type A and B standards or, if possible, also to other Type C standards and define safety requirements and identify the risks and priorities that are required. The principle is that the Type B and C standards cannot be repeated or verbally describe the text of the other standards to which they refer.
From a legal point of view, any product is safe, which is meeting the requirements of the relevant regulation or where no prescription for this product is meeting the standards requirements or corresponding to the state of scientific and technical knowledge known at the time of its placing on the market.
In general, the safety assessment rules for health and safety at work are based on the basic principle of meeting the requirements of the technical regulations and standards.
The requirements of directive 2006/42/EC support EN ISO 12100—defines the terminology and methodology used to achieve machine device safety. The purpose of this standard is to provide to the constructors a basic framework for designing safe machines. This standard has a historical development from the basic standard EN 292-1, 2, through EN 1050. Now it is replaced also EN ISO 14121-1 standard [1, 10].
The standard is principally structured to:
Risk assessment, i.e. basic principle and hazards identification.
Risk reduction, i.e. three-step method and measures.
This standard has a list of the potential hazards to be taken into account when designing a machine device (examples of hazards are part of Annex B, which is taken from the canceled standard ISO 14121-1. Hazards analysis must take into account the entire life-cycle of the machine—from its design, construction, manufacture, installation, operation and maintenance to its disposal.
This safety strategy—the risk assessment and risk management steps are defined as follows [1, 11, 12]:
Step 1: determination of machine boundaries, including intended use of the machine and consideration of its foreseeable misuse (e.g. operator errors),
Step 2: identification of hazard sources and hazardous situations,
Step 3: The risk estimation for each hazard and the resulting hazard situation,
Step 4: the risk evaluation and consideration of the necessary reduction by introducing measures,
Step 5: elimination of a hazard or risk reduction associated with hazards by applying appropriate measures (application of the so-called three-step risk reduction method).
The first three steps represent a process of risk analysis—a combination of specifications for determining the machine boundaries, hazard and hazard situations identification and risk estimation.
The overall procedure includes risk analysis and risk evaluation (fourth step). It is the process of risk assessment.
The risk management process is based on a risk assessment and proposes to take appropriate measures to implement and monitor their effectiveness.
Note: Risk assessment does not include a step of taking measures, only the steps of consideration—the classification of the estimated size of the risk according to the pre-selected scheme (e.g. the risk matrix) and the decision-making process “what to do with that now” based on the risk acceptance rate.
This risk management process is a basic and unchangeable process, and represents an iterative approach (ALARP—As Low As Reasonably Practicable), which the designer or constructor must observe in designing the machine, but also the user in managing workplace safety [1, 12].
The designer must consider designing the machine, all anticipated activities (even not expected ones during normal use of the machine), production must take into account possible risks in a machine manufacturing, the user (or the employer) must ensure the safety of the machine in the working environment.
The purpose of this step is to understand the principles of machine operation, the conditions and the way it is used. Determining machine boundaries serves to identify sources of hazards, a description of possible hazard scenarios while performing the required activities (e.g. machine operator and maintenance, visit, or third-party activities performed at the working site), or predictable behavior when using the machine by unskilled workers. Also an appropriate procedure is to define the so-called functional machine structures for identifying dangerous elements on the machine. It can be, for example a control function, safety function, stability function, etc.
Procedures to determine the machine boundaries according to EN ISO 12100 standard [1]:
Usage limits (intended use and foreseeable misuse)
Operating modes and preventive procedures, including manipulation with the machine when misused,
The way and the place for the machine use (household, industry) by persons, their skills and the ability to use the machine,
Expected level of qualification, experiences, education and capabilities of the concerned persons (a maintenance worker, an attendant, an apprentice or public),
Other persons who may be at risk from the machine (other machines operation, administrative staff, visits).
Layout: range of motion, operating and maintenance area, relationship between the machine and power source.
Time limit: machine lifespan (parts), maintenance intervals.
Other boundaries: properties of the processed material, purity, environment (temperature, external conditions, etc.).
After determining machine boundaries, the basic step of the risk assessment is to identify the types of hazard situation depending on the hazard properties of the machine, taking into account each stage of the machine’s life-cycle [1, 4, 8, 9, 11].
Account is also taken of the behavior of the operator [1, 11, 13], e.g.:
Loss of control by the operator (e.g. manual or mobile machines),
Improper behavior of the person in the event of failure of the machine, in the event of a breakdown or accident,
Behavior resulting from lack of a concentration or inattention,
Behavior resulting from the search for options beyond the prescribed procedure (instruction manual), the “least resistance way,”
Behavior resulting from the effort to keep the machine running at all costs,
Behavior of another group of people (children, people with disabilities).
EN ISO 12100 provides a description of 10 types of potential hazards (e.g. mechanical, electrical, thermal, noise, vibration, radiation, ergonomics, etc.), their potential sources and possible consequences. It is based on the requirements of the Machinery Directive.
Similarly, it is possible to proceed with identifying hazards in relation to the work being done at the workplace in order to assign appropriate personal protective equipment.
This is one of the most important risk assessment steps [1, 3, 9, 11]. The level of the risk reflects the severity of a hazardous situation and is dependent on the following parameters:
Consequence C or the severity of the hazard situation: the impact on health, property or environment,
Probability P of the damage occurrence that depends on:
Exposure of the person to the hazard situation, Exposure time: E,
Probability (or frequency) of occurrence of a hazard situation: PH,
Technical and human possibilities to prevent or limit the range of possible damage: M (measure).
The level of risk can be calculated as function of these parameters, using this formula:
The risk assessment uses simple methods based on the expression of probabilities and consequences and on the risk evaluation, so-called “Risk matrix” (risk rating tool) […].
Usually the level of risk is defined as combination of these parameters:
Creating a Risk matrix as a tool for analysis and risk assessment requires establishing criteria for estimating probabilities and consequences (Tables 2 and 3).
Probability | Level description of a probability | Level |
---|---|---|
Low | Low probability of event occurrence | 1 |
Medium | An event can be expected with a higher probability | 2 |
High | The probability of occurrence is almost certain | 3 |
Description of the probability of occurrence of a hazardous event: P.
Consequence | Level description of a severity/consequence | Level |
---|---|---|
Negligible | Small event impact range, minimal or no consequence, near-miss | 1 |
Serious | Medium range of an event consequence - serious consequence, injury—occupational accident (e.g. from 3 days off work) | 2 |
Very serious | Large range of an event consequence—very serious consequence, death or mass injury | 3 |
Description of the consequence C or the severity of the hazard situation: C.
For the risk assessor, the “common sense” principle must be applied to determine the range of the level of the assessed parameter (e.g. from 1 to 3).
The risk matrix (see Table 4) can be created by the “ordinary” multiplication of the individual levels assigned to the probability and consequence. The number of levels of the estimated parameters determines the type of matrix, for example, 3 × 3, 4 × 5, 6 × 4, etc. Determining the number of levels depends on the depth, to which the risk assessor intends to specify the probability and consequence of a negative effect.
Probability | Consequence | ||
---|---|---|---|
Negligible | Serious | Very serious | |
Low | 1 | 2 | 3 |
Medium | 2 | 4 | 6 |
High | 3 | 6 | 9 |
Risk matrix 3 × 3.
As can be seen from Table 4, the estimated risk sizes range from 1 to 9. In the next step, the risk (risk evaluation) needs to be evaluated, so for the assessor which level is high, medium, and low in severity level (e.g. acceptability) of the risk.
Values: 1–2 can be assigned to a low level, meaning small or low risk: L; from 3 to 4: medium level: M; from 6 to 9: high level: H.
For a better illustration, the Risk matrix can be adjusted more clearly, where the principle of so-called “traffic light” effect is applied, Table 5 [1, 9, 11].
Probability | Consequence | ||
---|---|---|---|
Negligible 1 | Serious 2 | Very serious 3 | |
Low 1 | L(1) | L(2) | M(3) |
Medium 2 | L(2) | M(4) | H(6) |
High 3 | M(3) | H(6) | H(9) |
Risk matrix 3 × 3 “traffic light”.
There is no binding rule to determine the level of a risk (e.g. H: high risk, M: medium risk, L: small or low risk), whether in qualitative, quantitative or semi-quantitative form. The applied methodology depends on the area of investigation (e.g. machine failure and its consequences) and data availability (e.g. monitoring machine failures) [6, 11].
Important at this stage of the risk assessment is to ensure sufficient information, e.g. historical data about machine failures, near-misses, injuries, accidents, as well as opinions of the experts and practitioners in the investigated area or system.
Risk analysis can be done principally in two ways, applied in specific methods [1, 11]:
Up-bottom approach (deductive methods)—lead off from information based on statistics of accidents and other undesirable events, analysis of their causes and consequences. So it is based on the events that have already occurred.
Bottom-up approach (inductive methods)—proceeds from the examination of all hazards and consideration of ways in which damage can occur, meaning: from predicting the probabilities and consequences of a possible undesirable event.
The choice of these methods depends on the experience and knowledge of the team that deals with the assessment process. The inductive methods may have the advantage over deductive methods in a more advanced analysis of all possible hazards and hazard situations but on the other hand they may be more time consuming.
Reducing the risk to the residual level is conditional on machines by following the three-step method—constructional measures excluding or limiting the risks; by installing the necessary protective systems and additional protective measure for those risks that could not be reduced or eliminated in the first step; by providing information on residual risks to the machine user (by providing the instructions for use) [1, 9, 11].
Step: Custom Construction Safety—this phase of the risk reduction is the most important. Even the most reliable protective systems and additional protective measures can fail during the life cycle of the machine.
Step: Safety protection and additional protection measures. Protective covers and protective devices must be used when their own construction safety has not adequately eliminated hazard and so does not sufficiently reduce the risk. In this case, another additional protective measure may be applied. Typical examples of protective measures include locking covers, light curtains, safety mats, two-hand control and activation switches. Additional protective measures are the devices which perform emergency stops, escape routes, equipment for manual start of certain parts during emergency stops, communication devices to make emergency calls, disconnection from the power source, handling devices (load lifting), and so on.
Step: User manual—information on safe use of the machine must be provided in the required quality, understandable language and to the extent that all information on the machine uses and its operating modes. They must inform and warn about the residual risk.
Residual risk—is a risk that remained after the adoption of the implemented measures (protective measures) so it can be manageable. It can describe protective or safety measures taken at the design stage or other additional measures taken by the user of the device, at the stage of its operation [1].
Machine safety under the Machinery Directive requires an integrated approach to the safety. However, the machine is a complex construction that is not only mechanical or electrical, but often times it is a complex control unit whose reliable function affects not only machine safety but also the whole process [6, 12, 14]. For this reason, safety integration is understood as a requirement not only for the safety of the machine itself, but also for the safety of the whole process (IEC 61511). Standard IEC 61511 defines requirements for safety control systems of continuous technological processes and on the other hand IEC 61508 defines functional safety requirements for electrical/electronic/programmable electronic safety systems (Figure 5) [1, 5, 10].
Relation between IEC 61508 and IEC 61511.
The objective of ISO 13849-1 (Type B-1) is to provide guidance on the design and construction of control (safety) systems so the requirement of integrated security is ensured.
A designer—constructor while reducing a risk considers applying safety measures that contain one or more safety features. The parts of machine control systems that provide a safety function are called safety-related parts of the control system and labeled as SRP/CP SRP—Safety related parts; CP—control system). They may consist of hardware and software, but may not be part of the machine’s control system.
Safety control systems are designed to perform a safety function. It’s the part of the control system (or the control system itself) that prevents the hazards. It could be said that it creates a barrier between hazards and hazards situation (e.g. shields). For these reasons, the safety system must work reliably, under all foreseeable circumstances.
The safety function is implemented by the machine components of the machine control system in such a way so it maintains the device (or bring it into a state) in a safe state with respect to the specific risk circumstances.
According to ISO 13849-1 standard, this is the function of a machine, whose failure can lead to an immediate increase of a risk.
The main task of the designer of the safety system is to avoid hazardous conditions and to prevent the possibility of an unintentional machine start.
The safety feature may have several parts, e.g. for a protective cover it is possible to define it in three steps:
When the cover is closed, the risks (for which the cover has been constructed) can not endanger the person,
By opening the cover, the exposure to an operational risk must be excluded,
Closing the cover does not restore the risk.
For safety systems, the use of “safety requirement or after safety requirement” are used as a result of their mode. An example of the requirement for the safety function is the interruption of the light curtain, the opening of the cover, where the operator may require to stop the machine parts or leave them without power if they had already been stopped after the safety function triggered [1, 5, 10].
The safety function is performed by the machine control system safety parts (elements). The safety function begins by sending a command and ends with a response (by doing an activity).
The safety system must be designed with a level of integrity that corresponds to the machine’s risk level. Higher risks require a higher level of integrity so the safety performance is ensured. The machine safety system can be partitioned to the performance level of the capability to ensure the performance of the safety function or otherwise, the functional level of safety integrity.
Functional safety—it is a part of the overall safety that depends on the correct functioning of the systems or devices in responding to their inputs (stimulus) [1, 10, 15].
Functional safety is the identification of potential hazards based on the activation of protective or corrective devices or mechanisms to prevent a dangerous event or to reduce the level of its consequence.
According to IEC 61508 standard, an example of functional safety is, for example, an overheat protection device that uses a thermal sensor in the motor winding to disconnect the voltage before it is overheated and subsequently could occur a destruction. But, e.g. a special insulation, resistant to high temperatures, is not an example of functional safety, even though it provides protection against the same hazards as a thermal sensor. Similarly, the fixed door as an intrusion barrier does not have a characteristics of the functional safety feature, like on the other hand, door locked housing.
In order to achieve the functional safety, it is necessary to meet the requirements for:
Safety function,
Safety integrity.
Risk assessment is the basis for creating the functional safety requirements: risk analysis provides the basis for the safety function requirements and risk evaluation forms the basis for specifying the safety integrity, i.e. the levels of system properties!
The basic standards for the functional safety of the machine control systems are [1, 5, 10, 15]:
IEC/EN 61508: Functional Safety of Electrical, Electronic/Programmable Electronic Safety Systems (Part 1, 2 and 3). This standard is general, not limited to the field of a machinery and contains requirements that apply to the design of complex electronic and programmable control systems.
IEC/EN 62061: Machine Safety—Functional Safety of Safety-Related Electrical/Electronic/Programmable electronic control systems that are connected with the safety. This is, in fact, a specific implementation of the IEC/EN 61508 standard for the machinery. The requirements of this standard can be applied to system level design for all types of electrical control systems as well as to not very complex subsystems and devices.
EN ISO 13849-1: Machine Safety—Safety Parts of Control Systems. This standard provides requirements and guidance for designing, constructing and integrating safety parts of the safety control systems (safety-related parts), including the software design. For these components, there are specific characteristics that include the power level required to ensure the safety function.
IEC 61511: Functional Safety. Safety Control Systems of Continuous Technological Processes. This standard was developed in accordance with the introduction of IEC/EN 61508 for industrial processes.
The application of standards has its own possibilities and limitations, e.g. IEC/EN 62061 and EN ISO 13849-1 standards, which deal with an electrical safety management systems (later on they should be unified), they use different methods to achieve their results, and the user can choose them as they are both harmonized under the EU Machinery Directive. The difference between them is in a use in different technologies. IEC/EN 62061 standard is restricted to electrical systems only, while the second ISO 13849-1 standard deals with pneumatic, hydraulic, mechanical and electrical systems.
This standard describes an extent of the risk, which needs to be reduced but also the capability of the control system to reduce this risk with the Safety Integrity Level (SIL) [5, 15]. In the field of machinery, there are three levels from SIL1 to SIL3 (highest level of integrity) are used.
Since the risks may also occur in a different industry, such as the petrochemical, energetic or a rail sector, e.g. in the manufacturing industry (applies specific standard IEC 61511), this standard also offers another category of the safety integrity level, SIL4.
The SIL category refers to the safety function. The subsystems or elements of the system, into which the safety function is implemented, must have the appropriate capability to be assigned to a particular SIL category. This capability is called SIL Claim Limit.
This standard does not use SIL, instead of that; it uses Performance Level (PL), properties level or performance. It defines five levels, where PLa is the lowest and PLe is the highest (Table 6) [1, 5, 15].
PL | PFDavg (average probability of a dangerous failure per hour) | SIL (safety integrity level) |
---|---|---|
a | ≥10−5 to <10−4 | No special safety requirements |
b | ≥3 × 10−6 to <10−5 | 1 |
c | ≥10−6 to <3 × 10−6 | 2 |
d | ≥10−7 to <10−6 | 3 |
e | ≥10−8 to <10−7 | 4 |
Relation between SIL and PL.
Application of adequate methods of determining SIL requirements depend on organization’s risk criteria.
Some standards offer similar methods, e.g. EN 61508 offers three methods: quantitative, risk graph, risk matrix and IEC 61511 offers more as semi-quantitative methods, Safety layer matrix and Layer protection analysis (LOPA) [5, 10].
The risk is an occurrence of a random event that can happen with a certain probability, when it occurs, it may have a negative impact on the organization’s business objectives.
In the process of a risk management, it is necessary to accept three principles [1, 3]:
The outcome of the assessment is uncertain. If it is certain, it is not possible to talk about the risk.
It is possible to assign at least one of the types of estimated negative consequences (high loss of property, death, environmental damage, financial loss, etc.).
Assessment depends on time and changing circumstances, that’s why it must be systematic and repeated.
These three principles are often ignored in practice. The manager in the company expects the results of the risk assessment to produce a clear result: “what is wrong and how to fix it” or “I did everything I could and we have no risks at all.”
Risk management, particularly in terms of social acceptability, is expressed through the ALARP principle (As Low As Reasonable Practicable). Its priority is to reduce the level of a risk “to such an extent as is reasonably practical,” while working with the level of risk between an unacceptable and fully acceptable (tolerable) level.
Acceptable Risk: represents a risk that is reduced to a level that can be tolerated in an organization, but at least it must respect provided requirements of binding regulations and the organization’s own policy [1, 3, 11].
ALARP was defined by health and safety executive (HSE) organization in Great Britain. The goal is to manage the residual risk to the extent that it is practical (bearable) for the organization. In Great Britain and New Zealand, this model is also described as SFAIRP (So Far As It Is Reasonably Practicable) in the USA by ALARA (As Low As Reasonably Achievable) [1, 12].
When implementing the ISO 31000 standard for considering the so-called “positive risk”— an assessment of opportunities, it would be possible to apply a new approach for assessing an effectiveness, that is AHARP (As High As Reasonably Practicable) [1, 12].
The OHS management system is part of the organization’s overall management system that creates and implements the OHS concept and manages health and safety risks. So it represents a set of mutually beneficial elements to make a policy and achieve the set goals.
The OHSAS 18001 standard required the most time to obtain the “standard” status. Since the safety requirements were different in each country and are strongly supported by the country’s legislation, the transition to standard was relatively slow.
After accepting the British BS 8800 standard, the ISO organization had issued for the first time the OHSAS 18001 standard in 1999, which was first revised in 2007. In 2017, transition to the HLS structure (High Level Structure) is expected, as well as the standard also gets a new definition by ISO 45001 standard [1, 3].
To understand connection between Machinery Safety and OHS management is important for organization maturity and its competitiveness. Management system requirements are coming from context description of organization operating (external and internal relationships). This context is a base for risk assessment process coming from organizational business activities and is defined as Risk-based Thinking principles (RBT) [1, 4]. Newly prepared standard ISO 45001:2017 requires proactively approach in Risk Management processes. RBT distinguishes term risk and term opportunities, and also is linked with principles of ISO 31000. This brings a natural pressure for assuming methods and tools for risk assessment in relation with organization objectives on all management level.
This work was developed within the projects APVV-15-0351 “Development and Application of a Risk Management Model in the Setting of Technological Systems in Compliance with Industry 4.0 Strategy” and 7FP entitled “iNTegRisk,” no. CP-IP213345-2 and co-financed by APVV based contract No. DO7RP-0019-08.
Materials with the possibility of performing a biological function are increasingly sought. In the medical field, implants require a high compatibility with the hard tissue for osteointegration and bone formation and a compatibility with the soft tissue for the adhesion of the epithelium to them and the acquisition of antibacterial properties for inhibiting or forming the biofilm at the interface. These biofunctional characteristics have two contradictory properties: inhibition and enhancement of protein adsorption, respectively, and cell adhesion [1, 2].
The usual classification of synthetic biomaterials is carried out structurally, according to the classes of materials used. The main types of synthetic biomaterials are metallic, ceramic, polymeric, composite, and of natural origin, but they can also be divided into several categories, as can be seen in Figure 1.
The main types of biomaterials [4].
Biocompatible materials are intended to “work under biological constraint” and thereby become adapted to various medical applications.
When a metallic material is implanted in a human body, immediate reactions occur between their surface and the living tissues. In other words, an immediate reaction during the introduction period is determined and defines the biofunctionality of the metallic material [3].
The quality of a material used in the construction of an implant must respect the following two criteria: the biochemical criterion and the biomechanical criterion. According to the biochemical criterion, the applicability of a material is determined by its biocompatibility, and from the biomechanical point of view of fatigue resistance, it is the most important parameter but not the only one.
The most used metallic biomaterials are stainless steels, Co-Cr alloys, titanium alloys, and magnesium-based alloys. Each class of biomaterials has its advantages and disadvantages (Figure 2), their use in the execution of different implants being influenced by both the properties of the biomaterials and the functional requirements imposed to the implants [5].
Main characteristics of metallic orthopedic implants [6].
Among the most important factors that intervene on a biomaterial successfully integrated in the human body, we mention the physical-chemical properties, the design, the biocompatibility, the surgical technique applied to the implantation, and last but not least, the patient’s health.
The selection of materials used in contact with living cells or tissues for implantation in the human body, as biomaterials, is determined primarily by their acceptance by the human tissues with which they interact (biocompatibility) and by the ability to perform their functional role for which they were implanted (biofunctionality) [6].
Out of the metallic biomaterials, a special interest is for those with osteotropic structure, of which the titanium belongs. These biomaterials, thanks to the chemical and micromorphological biocompatibility with the bone tissue, achieve with this physical-chemical connection, the interface phenomenon being assimilated with the linking osteogenesis.
Titanium alloys are frequently used, due to the need of replacing stainless steels and cobalt-based alloys that have limitations in use, causing some deficiencies of biocompatibility with human tissues. These deficiencies are caused by some elements present in their chemical composition (e.g., nickel), which have a toxic effect on human tissues, causing inflammatory allergic reactions or implant rejection reactions [7].
The properties of the titanium are as follows:
melting point—the titanium melts at 1660°, and it can be sterilized without risk at 300°;
resistance—the implants are made from a single pure titanium bar by mechanical processing, giving them maximum resistance;
hardness—the titanium has a hardness comparable to that of steel, giving it special mechanical quality;
rigidity—the implants do not deform when applying, mounting, or milling forces nor in the biomechanics of chewing;
nonmagnetic—the titanium has no magnetic effect, resulting in good tissue supportability;
regenerative and therapeutic action—research and practical experience have highlighted the healing qualities of titanium oxide;
neutral pH—titanium dioxide, TiO2, which is formed immediately around the metal molecules, has a pH of 7, completely neutral;
biological immunity—the implant can be stimulated in contact with the bone, surrounding tissues and the oral cavity environment;
excellent resistance to electric shock—the titanium has a very low thermal conductivity; and
light weight—the density of titanium is close to that of light alloys [4, 8].
The biocompatibility of titanium is a consequence of the presence of the superficial oxide layer. The chemical properties and therefore the chemical processes on the interface are determined precisely by this layer of oxide and not by the metal itself. This feature is applicable to all metal materials used in the manufacturing of implants and prosthetic parts. Among the metal materials used for hard tissue repair in human body, the elastic modulus of titanium (about 80–110 GPa) is the closest to hard human tissue, which can reduce the mechanical incompatibility between metal implants and bone tissue [9].
Titanium alloys are used for medical applications in multiple fields in human body and became the first choice for orthopedic products. Figure 3 shows the main applications of titanium alloys used in orthopedic applications [2, 3, 4, 5, 6, 7, 8].
Orthopedic products made by titanium and titanium alloys: (a) endoprosthesis for joint replacement; (b) system plate screws for bone fracture repair; (c) screws for bone repair; and (d) intramedullary nail [2, 9].
In conclusion, it can be said that titanium biomaterials, by its properties, respond to almost all the requirements necessary for the achievement of osteogenesis, osteointegration, and durability over time. The pure titanium implant offers perfect compatibility, correct and concrete osteogenesis, and demonstrable time-lapse viability.
Adding the alloying elements gives titanium a wide range of properties through different microstructures and properties.
After microstructure, the alloys are grouped into three categories depending on the type of stabilizing elements added to the titanium alloy. The mechanical properties and corrosion resistance of the alloys depend on the morphology and structure of the α or β phase particles in the alloy matrix.
Thus, the alloying elements are divided into three categories as follows:
α stabilizers: C, N2, O2, and Al;
β stabilizers: V, Nb, Mo, Ta, Fe, Mn, Cr, Co, W, Ni, Cu, Si, and H2; and
Over the years, many titanium alloys have been developed and investigated for the implantation of implants for medical applications, of which few have been accepted by the human body, namely those that have certain properties necessary for long-term success.
The biocompatibility of an alloy depends on the alloying elements. Alloying elements such as Zr, Ta, Nb, and Sn do not affect cell viability and have shown a reduced amount of ions released into the body, but Al and V contribute to reducing cell viability. Other elements such as Ag, Co, Cr, and Cu have moderate cytotoxic behavior, but their presence in these alloys significantly reduces their toxicity [1, 2, 3, 4, 5]. By analyzing the current research, these alloys were studied in order to develop new recipes of titanium-based alloys with elements with high biocompatibility on human tissue such as Mo, Ta, Zr, and Si [10, 11].
The experimental tests aim at a characterization of new developed titanium alloys by chemical, structural, surface, and mechanical analyses.
This chapter describes the following investigations for the new alloys developed:
Development of alloys was carried out using a Vacuum Arc Remelting installation for the elaboration of homogeneous alloys.
Elemental composition is necessary to determine the percentages of the chemical elements that make up the elaborated titanium alloys.
Structural characterization is necessary for the study of the microstructure, the crystallographic orientation, the texture, and the identification of the constituent phases.
Mechanical characterization highlights the mechanical properties of the developed titanium alloys: hardness and elasticity module.
Corrosion resistance determines the stability of the proposed alloys in the simulated body fluids.
Surface characterization takes into account the measurement of the contact angle of the surface of the alloys for achieving/optimizing the adhesion and cell proliferation.
In order to obtain the titanium alloys, the MRF ABJ 900 Vacuum Arc Remelting has been used. Vacuum arc remelting is a commonly used process in the development of alloys. The process itself is used to refill the ingots and refine the structure by using nonconsumable mobile electrode of thorium tungsten. The process itself can also be used to obtain special alloys, superalloys, and titanium alloys.
In principle, the process of remelting with a vacuum arc is a process based on continuous melting with the use of the electric arc and nonconsumable mobile electrode.
Advantages of using this equipment are as follows:
It can achieve very high melting temperatures.
It ensures the possibility of melting the metallic vacuum samples under a protective atmosphere by means of a nonconsumable mobile electrode of thorium tungsten.
It creates alloys with uniform composition, through repeated remeltings.
It ensures the possibility of mixing elements with different melting temperatures.
It can use various crucibles for elaboration and ensure the possibility of obtaining the samples under specific conditions in the form of a pill of different shapes and sizes.
Loading and unloading is done in a simple way by lifting the cover that is caught in the hinge to the rest of the camera.
It is illuminated with a halogen lamp, thus helping to control the melting of the alloying elements in the process [12].
Figure 4 shows all stages of titanium alloying, which includes the weighing of the raw material, the loading of the alloying elements, and the final semi-finished obtained products.
Stages of titanium alloying obtaining process: (a) weighing of raw materials and gravimetric dosing; (b) loading of the raw material; and (c) titanium semi-products obtained after solidification [12].
The load calculation has considered the characteristics of the different alloying elements and their physical-chemical properties.
Elaboration of the alloys was carried out in two charges to obtain two alloys in each charge. Table 1 shows alloys proposed the cavities used for each alloy.
Alloy element | Ti | Mo | Si | Zr | Ta |
---|---|---|---|---|---|
(% weight) | |||||
Ti15Mo0.5Si | 84.50 | 15.00 | 0.50 | — | — |
Ti20Mo0.5Si | 79.50 | 20.00 | 0.50 | — | — |
Ti15Mo7Zr10Ta | 68.00 | 15.00 | — | 7.00 | 10.00 |
Ti20Mo7Zr10Ta | 63.00 | 20.00 | — | 7.00 | 10.00 |
Chemical composition proposed of the new titanium alloys.
Elaboration of the titanium alloys made with a vacuum arc melting system, took place by the melting of the elements, and followed by the remeltings of alloys for six times, a necessary operation for the refining and homogenization of the alloys. The melting of the elements took place uniformly, resulting alloys with a precise and homogeneous chemical composition. The samples had a homogeneous structure, which means that the installation, the elaboration protocol, and the elements were chosen correctly.
After the solidification, two samples of each alloy were obtained in the form of ingots, shapes, and different masses but with sufficient quantity for taking the specimens required for all proposed laboratory tests.
A complete characterization of a metallic material consists in knowing its composition, the concentration of the various elements, or the impurities in the mass of the alloy. An extremely important aspect is the determination as precisely as possible of the chemical composition of the titanium alloys obtained after elaboration.
The EDAX system is a microanalysis detector, equipped with an electron microscope, which uses the resulting X-ray energy on the surface of the samples.
Determination of chemical composition can be performed, both punctually and in a well-defined region on the surface of the analyzed sample.
This method is a variant of X-ray fluorescence spectroscopy, in which the sample investigation is based on the interactions between the electromagnetic radiation and the sample, analyzing the X radiation emitted by the sample as a response to the charging of particles loaded with electric charges. The characterization possibilities are largely according to the fundamental principle that each chemical element has a unique atomic structure that allows the characteristic X-rays of the atomic structure of an element to characterize it uniquely from another.
In order to achieve the structural and thermal characterization, it is necessary to identify the chemical composition of the alloys obtained. EDAX microanalysis with energy dispersion of X radiation was used to determine the chemical composition of the TiMo alloys developed. Determination of the chemical composition by EDAX microanalysis is the first laboratory investigation required to highlight the proportions obtained between the pure chemical elements and was performed on titanium alloys obtained.
In order to validate the results regarding the concentration, for each sample, 10 measurements on five different areas were done.
To determine the chemical composition of the obtained titanium alloys, the Vega Tescan LMH II equipment was performed using the EDAX by Bruker attached to the SEM equipment.
For the determination of the chemical composition of alloys obtained from the TiMo system, samples having dimensions of 10 mm × 10 mm × 5 mm were used. Before being examined, the samples were ground on abrasive paper to remove impurities and titanium oxide film on the surface of the alloy.
Table 2 shows the mass percentages of the elements identified in the alloy composition, the percentages of the elements varying slightly with the theoretical batch calculation.
Alloy element | Ti | Mo | Si | Zr | Ta |
---|---|---|---|---|---|
(% weight) | |||||
Ti15Mo0.5Si | 79.28 | 19.95 | 0.77 | — | — |
Ti20Mo0.5Si | 78.98 | 20.06 | 0.96 | — | — |
Ti15Mo7Zr10Ta | 75.40 | 10.41 | — | 7.69 | 6.50 |
Ti20Mo7Zr10Ta | 71.51 | 14.05 | — | 7.04 | 7.40 |
Chemical compositions of titanium alloys, expressed as a mass percentage, according to the EDX measurements.
Figures 5–8 highlight EDX spectrum and element mapping of titanium alloys.
EDX spectrum and mapping for Ti15Mo0.50Si alloy.
EDX spectrum and mapping for Ti20Mo0.50Si alloy.
EDX spectrum and mapping for Ti15Mo7Zr10Ta alloy.
EDX spectrum and mapping for Ti20Mo7Zr10Ta alloy.
The analysis of the chemical composition obtained revealed that the main elements identified in the alloys elaborated are Ti, Mo, Zr, Ta, and Si, without the presence of other inclusions.
Microscopic methods of structural analysis are used to characterize the materials based on their structure, constituents and phases present (nature, shape, dimensions, and distribution), and possible structural defects (pores, cracks, structural inhomogeneities, etc.). Structural analysis was performed using the OPTIKA XDS-3 MET microscope.
In order to investigate the metallographic structure, the preparation of the metallographic samples of the experimental titanium alloys included a sequence of steps: cutting to appropriate dimensions (e.g., 10 mm × 10 mm × 5 mm), incorporation in epoxy resin, grinding and polishing, and chemical attack with specific reagents (a solution with 10 mL of HF, 5 mL of HNO3, and 85 mL of H2O) for 30 s. After the preparation of the samples, this was analyzed at the optical microscope at various magnification powers in order to obtain detailed images on the microstructure.
Figure 9 highlights images obtained by optical microscopy for titanium alloys at 100× magnification.
Optical microstructure of alloys investigated at 100× magnification power: (a) Ti15Mo0.5Si, (b) Ti20Mo0.5Si, (c) Ti15Mo7Zr10Ta, and (d) Ti20Mo7Zr10Ta.
In Figure 9, the structure of titanium alloys with aspects of the specific grains of titanium is presented. The images obtained by optical microscopy for the elaborated alloys show a dendritic structure with irregular grain boundaries. These coarse structures are specific to β alloys.
The variation of the α, α + β, and β type phases consists of the differences in chemical composition of the constituent elements. The high percentage of β-stabilizing elements (Mo, Ta, and Si) led to the formation of a β-type structure, very well highlighted in the elaborated TiMo alloys.
The measurement of the longitudinal elastic modulus for the obtained titanium alloys was achieved by the microindentation method. This method consists of penetrating the surface of the sample with a conical palpate at a certain force.
From a practical point of view, the indentation characterization presents a major advantage over the standard methods of testing on standardized tests, namely, the testing can be done directly on the finished pieces.
During the microindentation test, the values of the loading forces are recorded relative to the penetration depth of the indenter in the material. Based on the loading-unloading curve, a number of sizes can be determined that allow the characterization of the materials.
Figure 10 shows the response of the alloys during the indentation tests in the form of force-depth dependencies. The values of the modulus of elasticity for the titanium alloys resulting from the indentation test are shown in Table 3.
The force-depth curve of the micro-indentation test for the investigated alloys: (a) Ti15Mo0.5Si, (b) Ti20Mo0.5Si, (c) Ti15Mo7Zr10Ta, and (d) Ti20Mo7Zr10Ta.
Alloy | Ti15Mo0.5Si | Ti20Mo0.5Si | Ti15Mo7Zr10Ta | Ti20Mo7Zr10Ta | C.p. Ti | Ti6Al4V | CoCr alloys | Human bone |
---|---|---|---|---|---|---|---|---|
Elastic modulus (GPa) | 19.81 | 37.53 | 76.88 | 43.41 | 105 | 110 | 240 | 17 |
Among the mechanical properties that are considered when evaluating a biomaterial is the longitudinal elasticity module. If the biomaterial is used for orthopedic implants, it must have a modulus of longitudinal elasticity equivalent to that of the bone, which varies between 4 and 30 GPa, depending on the type of bone and the direction of measurement [13, 14, 15].
A low modulus is reliable in inhibiting the bone resorption and enhancing the remodeling of bones, which may be due to the excellent stress transmission between the bone and the implant. A biomedical orthopedic implant should have a Young modulus matching or closer to that of human bone to avoid the stress shielding effect.
The developed titanium alloys have a low modulus of elasticity, close to that of the bone, with the exception of the Ti15Mo7Zr10Ta alloy and significantly lower values than CoCr alloys.
If the balance between mechanical properties and biocompatibility is achieved by both the implant and the bone tissue, the risk of negative effects is very small. The use of titanium materials with a low modulus of elasticity seems to be a good solution, and the chances of using the material for medical purposes are increasing.
Hardness is a property of materials that express their ability to resist the action of mechanically penetrating a tougher body into its surface. When determining the hardness of the materials, the size of the traces produced by a penetration body, characterized by a certain shape and size, and the force acting on it is taken into account.
The methods for determining the hardness, depending on the speed of the force on the penetrator, are classified into static methods, where the drive speed is below 1 mm/s, and dynamic methods for which the drive speed exceeds this value.
The Vickers hardness determination method uses a diamond penetrator in the form of a pyramid with a square base and consists in pressing it at a reduced speed and with a certain predetermined force F on the surface of the test material. The Vickers hardness, symbolized by HV, is expressed by the ratio of the applied force F to the area of the lateral surface of the residual trace produced by the penetrator. The trace is considered to be a straight pyramid with a square base, with diagonal d, having the same angle as the penetrator at the top.
For the Vickers hardness determination method, at least three attempts are made on the test material. For each trace, the average diagonal value is calculated based on the magnitude of the two diagonals measured. It is recognized that the difference in diagonal dimensions is within an error margin of not more than 2%.
The hardness measurements highlight resistance and provide information on the behavior of the studied materials. In this way, we can analyze titanium alloys developed for the purpose of fitting them into a specific medical application (Table 4).
Alloy | Ti15Mo0.5Si | Ti20Mo0.5Si | Ti15Mo7Zr10Ta | Ti20Mo7Zr10Ta | C.P. Ti | Ti6Al4V | CoCr alloys |
---|---|---|---|---|---|---|---|
HV | 233.37 | 165.18 | 462.33 | 321.31 | 128 | 381 | 600 |
HV hardness measurements on titanium alloys were performed with Wilson Wolpert 751N.
Both systems studied have different hardness results. Compared to other titanium biomaterials, TMZT alloys have a higher hardness, but close to the Ti6Al4V alloy, which are most commonly used in implantology. An important aspect that might have contributed to the increased hardness is the amount of stabilizing β elements. It can be observed that as the amount of stabilizing β elements increases (Mo and Ta), it decreases the hardness values.
Corrosion represents the physical-chemical, spontaneous, reversible, and undesirable destruction of metals and alloys under the chemical, electrochemical, or biological action of the environment.
Corrosion monitoring is the practice of qualitative assessment and quantitative measurement of the corrosivity of an environment on a metal or an alloy immersed in this environment. Monitoring tests can be performed using mechanical, electrical, electrochemical, or chemical methods [18, 19, 20]. The nature of the monitoring sensor depends on the technique chosen for the study, the purpose pursued, and the particular characteristics of the sample used. In the older methods, the electrical measurements were often used, the monitoring technique and the methods of processing the experimental data being generally very laborious. The advances in the field of microelectronics have allowed the signals of the electrochemical sensors to be strictly conditioned, appropriately amplified, and processed based on complex data processing programs.
Some techniques and methods of measurement allow continuous monitoring of corrosion—the sample is permanently exposed in the corrosion environment, while the discontinuous methods are done only in specialized laboratories.
Some techniques give direct information on material degradation or corrosion rate, while others are used to determine if a corrosive environment may exist. Also, some techniques are “destructive” altering more or less the surface of the metal, while others are nondestructive. The true methods of monitoring the corrosion are considered very sensitive measurements, which give a practical instantaneous signal, simultaneously with the change of the corrosion speed.
To obtain a more complete picture of the corrosion process, it is often necessary to obtain complementary data, from other sources or sensors, which are purchased simultaneously with those obtained from the corrosion sensor.
Three main aspects are pursued in the study of corrosion of alloys in various environments: (1) the type of corrosion involved in the process; (2) the corrosion rate; and (3) the nature of the corrosion products and their properties (chemical, structural, and protective). For this, numerous study methods can be used, which can be divided into three main classes: analytical methods, electrochemical methods, and optical methods. But in special cases, other methods are used (acoustic, nuclear, etc.).
Electrochemical impedance spectroscopy (SIE) data, were processed with the ZSimpWin software [8], in which the spectra are interpreted by the fit procedure developed by Boukamp - by the smallest squares method. In order to process with this software the data acquired by the VoltaMaster 4 program, this were converted by using the EIS file converter program.
The polarization resistance method was used to evaluate the corrosion rate. This method serves to determine the corrosion current, at the corrosion potential of the metal or alloy, from the linear polarization curve obtained for relatively small overvoltages. The corrosion current determined by this method therefore represents the current that appears at the metal/corrosive medium interface when the metal is immersed in the solution and represents the instantaneous corrosion current.
All measurements were made on freshly cleaned surfaces. Each sample was polished on SiC abrasive paper until granulation 2000, degreased with acetone, washed with distilled water, and kept in bidistilled water until introduced into the electrochemical cell.
Figure 11 shows the linear polarization curves in semi-logarithmic coordinates for the samples studied in the Ringer solution, and in Table 5, the parameters of instantaneous corrosion in the same physiological environment are presented.
Linear polarization curves in semi-logarithmic coordinates for titanium alloys developed in Ringer’s solution: (a) Ti15Mo0.5Si, (b) Ti20Mo0.5Si, (c) Ti15Mo7Zr10Ta, and (d) Ti20Mo7Zr10Ta.
Alloy element | Ecor [mV] | Rp [kΩ/cm2] | Jcor [μA/cm2] | Vcor [μm /an] | βa [mV] | βc [mV] |
---|---|---|---|---|---|---|
Ti15Mo0.5Si | −266 | 14.91 | 2.131 | 20.59 | 200 | −192 |
Ti20Mo0.5Si | −227 | 17.71 | 2.089 | 20.19 | 310 | −142 |
Ti15Mo7Zr10Ta | −400.10 | 46.22 | 0.37 | 4.31 | 92.10 | −91.20 |
Ti20Mo7Zr10Ta | −425.50 | 50.33 | 0.38 | 4.47 | 130.20 | −10.430 |
Instantaneous corrosion parameters for titanium alloys developed in Ringer’s solution.
The corrosion potential, Ecor, measured in relation to the potential of the saturated calomel electrode, is the potential at which the oxidation-reduction reactions on the surface of the alloy are at equilibrium; the speed of the oxidation reaction is equal to the rate of the reduction reaction, and the total current intensity is zero. As the potential increases toward more positive values, the speed of the oxidation reaction increases, while the movement of the potential toward negative values, the oxidation process is reduced and the metal is passivized. As a qualitative aspect, the TiMoSi alloy series has a higher corrosion tendency than the TiMoZrTa alloys. The differences are significant, and the presence of zirconia and tantalum seems to cause a decrease in the corrosion rate.
The polarization resistors have high values, which are reflected in very low corrosion rates. The product of “corrosion” in the case of these alloys is mainly titanium oxide, TiO2, which is insoluble and adherent to the surface of the alloy. The oxide layer on the surface protects the alloy from the ages of the electrolytic media. In view of this, it can be admitted that in the artificial physiological environment, Ti-based alloys do not corrode but in fact undergo a passivation process. Under these conditions, the parameter Vcor—called corrosion rate—is actually passivation speed.
One of the requirements of biomaterials is cellular adhesion on the surface of the material, depending on surface energy. The contact angle between a drop of liquid and a solid surface is a sensitive indicator of changes in surface energy and of the chemical and supramolecular structure on the surface. Specialty studies in domain indicated that contact angle measurement is important for the study of cell adhesion to the surface, being the one that characterizes the hydrophobicity of the studied material [21, 22].
Measurement of the contact angle (Figure 12) is an experimental technique used to evaluate the hydrophilic or hydrophobic character of the surfaces. Surfaces can be classified as hydrophilic or hydrophobic reported at 90°. If the angle of contact is between 0 and 90°, the material is hydrophilic, and if the angle of contact is between 90 and 180°, material is hydrophobic.
Images of water droplet on the surface of the elaborated alloys: (a) Ti15Mo0.5Si, (b) Ti20Mo0.5Si, (c) Ti15Mo7Zr10Ta, and (d) Ti20Mo7Zr10Ta.
The equipment used allows the determination of the surface tension of the liquids and of the free surface energy of the solid. The principle of measuring the angle of contact consists in placing a drop of water with a microsurgery syringe with the drop volume of 4 μl. Drop lighting is made from behind and recorded from the opposite side with a digital camera. The image obtained is further analyzed through the FAMAS program, a KYOWA integrated goniometer software.
Ten measurements of the contact angle (θ) for each experimental alloy were performed, and the value presented is the average of the measurements made, with a maximum error of ±1°. The average value of the contact angle for each alloy is shown in Table 6.
Alloy | Ti15Mo0.5Si | Ti20Mo0.5Si | Ti15Mo7Zr10Ta | Ti20Mo7Zr10Ta |
---|---|---|---|---|
Liquid used | water | water | water | water |
Contact angle (°) | 64.40 | 50.00 | 45.64 | 70.72 |
Water contact angle values on the surface of elaborated titanium alloys.
All investigated alloys have a contact angle of less than 90°, thus having a hydrophilic character, which means a high adhesion of the cells to the surface of the alloys.
From the data obtained for the analyzed titanium alloy surfaces, it follows that the value of the highest arithmetic mean of the alloys is recorded at the level of contact angle with water on the surface of the Ti15Mo7Zr10Ta alloy, and the smallest level was Ti20Mo7Zr10Ta alloy, this alloy having a more pronounced hydrophilic character.
Metals have traditionally been used to make implants subjected to high loads in the human body, used in various applications. They are known for their high resistance to wear, ductility, hardness, corrosion, and biocompatibility.
For a biomaterial to be functional for an extended period of time in the body, it should be nontoxic and engage in an adequate response with the body, so that it can fulfill its purpose.
The preliminary investigations presented in this chapter for the elaborated titanium alloys revealed the beneficial influence of some stabilizing β elements (Mo, Ta, and Si).
The alloys developed by the proposed method have the advantage of a modulus of elasticity close to that of the human bone and a good corrosion resistance in the simulated biological fluids. According to the obtained values for corrosion and the mechanical properties, the newly developed alloys, for a Young modulus, the value is the closest to the bone (from 19 to 77 GPa our alloys, C.p. Ti is 105 GPa, and the rest are higher, where the bone is 17 GPa) from all the commercial known alloys, and TMZT systems have the lowest corrosion rate. Also, according to the contact angle, the surfaces of the obtained alloys are susceptible for cell development.
Because improving the properties of biomaterials is a necessity to reduce the failure rate of implants in human tissue, we can say that the alloys developed in this chapter can be successful candidates for orthopedic implants, thanks to the stabilizing β elements.
IntechOpen implements a robust policy to minimize and deal with instances of fraud or misconduct. As part of our general commitment to transparency and openness, and in order to maintain high scientific standards, we have a well-defined editorial policy regarding Retractions and Corrections.
",metaTitle:"Retraction and Correction Policy",metaDescription:"Retraction and Correction Policy",metaKeywords:null,canonicalURL:"/page/retraction-and-correction-policy",contentRaw:'[{"type":"htmlEditorComponent","content":"IntechOpen’s Retraction and Correction Policy has been developed in accordance with the Committee on Publication Ethics (COPE) publication guidelines relating to scientific misconduct and research ethics:
\\n\\n1. RETRACTIONS
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\\n\\nA Statement of Concern detailing alleged misconduct will be issued by the Academic Editor or publisher following a 3rd party report of scientific misconduct when:
\\n\\nIntechOpen believes that the number of occasions on which a Statement of Concern is issued will be very few in number. In all cases when such a decision has been taken by the Academic Editor the decision will be reviewed by another editor to whom the author can make representations.
\\n\\n3. CORRECTIONS
\\n\\nA Correction will be issued by the Academic Editor when:
\\n\\n3.1. ERRATUM
\\n\\nAn Erratum will be issued by the Academic Editor when it is determined that a mistake in a Chapter originates from the production process handled by the publisher.
\\n\\nA published Erratum will adhere to the Retraction Notice publishing guidelines outlined above.
\\n\\n3.2. CORRIGENDUM
\\n\\nA Corrigendum will be issued by the Academic Editor when it is determined that a mistake in a Chapter is a result of an Author’s miscalculation or oversight. A published Corrigendum will adhere to the Retraction Notice publishing guidelines outlined above.
\\n\\n4. FINAL REMARKS
\\n\\nIntechOpen wishes to emphasize that the final decision on whether a Retraction, Statement of Concern, or a Correction will be issued rests with the Academic Editor. The publisher is obliged to act upon any reports of scientific misconduct in its publications and to make a reasonable effort to facilitate any subsequent investigation of such claims.
\\n\\nIn the case of Retraction or removal of the Work, the publisher will be under no obligation to refund the APC.
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\\n"}]'},components:[{type:"htmlEditorComponent",content:'IntechOpen’s Retraction and Correction Policy has been developed in accordance with the Committee on Publication Ethics (COPE) publication guidelines relating to scientific misconduct and research ethics:
\n\n1. RETRACTIONS
\n\nA Retraction of a Chapter will be issued by the Academic Editor, either following an Author’s request to do so or when there is a 3rd party report of scientific misconduct. Upon receipt of a report by a 3rd party, the Academic Editor will investigate any allegations of scientific misconduct, working in cooperation with the Author(s) and their institution(s).
\n\nA formal Retraction will be issued when there is clear and conclusive evidence of any of the following:
\n\nPublishing of a Retraction Notice will adhere to the following guidelines:
\n\n1.2. REMOVALS AND CANCELLATIONS
\n\n2. STATEMENTS OF CONCERN
\n\nA Statement of Concern detailing alleged misconduct will be issued by the Academic Editor or publisher following a 3rd party report of scientific misconduct when:
\n\nIntechOpen believes that the number of occasions on which a Statement of Concern is issued will be very few in number. In all cases when such a decision has been taken by the Academic Editor the decision will be reviewed by another editor to whom the author can make representations.
\n\n3. CORRECTIONS
\n\nA Correction will be issued by the Academic Editor when:
\n\n3.1. ERRATUM
\n\nAn Erratum will be issued by the Academic Editor when it is determined that a mistake in a Chapter originates from the production process handled by the publisher.
\n\nA published Erratum will adhere to the Retraction Notice publishing guidelines outlined above.
\n\n3.2. CORRIGENDUM
\n\nA Corrigendum will be issued by the Academic Editor when it is determined that a mistake in a Chapter is a result of an Author’s miscalculation or oversight. A published Corrigendum will adhere to the Retraction Notice publishing guidelines outlined above.
\n\n4. FINAL REMARKS
\n\nIntechOpen wishes to emphasize that the final decision on whether a Retraction, Statement of Concern, or a Correction will be issued rests with the Academic Editor. The publisher is obliged to act upon any reports of scientific misconduct in its publications and to make a reasonable effort to facilitate any subsequent investigation of such claims.
\n\nIn the case of Retraction or removal of the Work, the publisher will be under no obligation to refund the APC.
\n\nThe general principles set out above apply to Retractions and Corrections issued in all IntechOpen publications.
\n\nAny suggestions or comments on this Policy are welcome and may be sent to permissions@intechopen.com.
\n\nPolicy last updated: 2017-09-11
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She performed research in perioperative autotransfusion and obtained the degree of PhD in 1993 publishing Peri-operative autotransfusion by means of a blood cell separator.\nBlood transfusion had her special interest being the president of the Haemovigilance Chamber TRIP and performing several tasks in local and national blood bank and anticoagulant-blood transfusion guidelines committees. Currently, she is working as an associate professor and up till recently was the dean at the Albert Schweitzer Hospital Dordrecht. She performed (inter)national tasks as vice-president of the Concilium Anaesthesia and related committees. \nShe performed research in several fields, with over 100 publications in (inter)national journals and numerous papers on scientific conferences. \nShe received several awards and is a member of Honour of the Dutch Society of Anaesthesia.",institutionString:null,institution:{name:"Albert Schweitzer Hospital",country:{name:"Gabon"}}},{id:"83089",title:"Prof.",name:"Aaron",middleName:null,surname:"Ojule",slug:"aaron-ojule",fullName:"Aaron Ojule",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"University of Port Harcourt",country:{name:"Nigeria"}}},{id:"295748",title:"Mr.",name:"Abayomi",middleName:null,surname:"Modupe",slug:"abayomi-modupe",fullName:"Abayomi Modupe",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/no_image.jpg",biography:null,institutionString:null,institution:{name:"Landmark University",country:{name:"Nigeria"}}},{id:"94191",title:"Prof.",name:"Abbas",middleName:null,surname:"Moustafa",slug:"abbas-moustafa",fullName:"Abbas Moustafa",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/94191/images/96_n.jpg",biography:"Prof. Moustafa got his doctoral degree in earthquake engineering and structural safety from Indian Institute of Science in 2002. He is currently an associate professor at Department of Civil Engineering, Minia University, Egypt and the chairman of Department of Civil Engineering, High Institute of Engineering and Technology, Giza, Egypt. He is also a consultant engineer and head of structural group at Hamza Associates, Giza, Egypt. Dr. Moustafa was a senior research associate at Vanderbilt University and a JSPS fellow at Kyoto and Nagasaki Universities. He has more than 40 research papers published in international journals and conferences. He acts as an editorial board member and a reviewer for several regional and international journals. His research interest includes earthquake engineering, seismic design, nonlinear dynamics, random vibration, structural reliability, structural health monitoring and uncertainty modeling.",institutionString:null,institution:{name:"Minia University",country:{name:"Egypt"}}},{id:"84562",title:"Dr.",name:"Abbyssinia",middleName:null,surname:"Mushunje",slug:"abbyssinia-mushunje",fullName:"Abbyssinia Mushunje",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"University of Fort Hare",country:{name:"South Africa"}}},{id:"202206",title:"Associate Prof.",name:"Abd Elmoniem",middleName:"Ahmed",surname:"Elzain",slug:"abd-elmoniem-elzain",fullName:"Abd Elmoniem Elzain",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Kassala University",country:{name:"Sudan"}}},{id:"98127",title:"Dr.",name:"Abdallah",middleName:null,surname:"Handoura",slug:"abdallah-handoura",fullName:"Abdallah Handoura",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"École Supérieure des Télécommunications",country:{name:"Morocco"}}},{id:"91404",title:"Prof.",name:"Abdecharif",middleName:null,surname:"Boumaza",slug:"abdecharif-boumaza",fullName:"Abdecharif Boumaza",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"Abbès Laghrour University of Khenchela",country:{name:"Algeria"}}},{id:"105795",title:"Prof.",name:"Abdel Ghani",middleName:null,surname:"Aissaoui",slug:"abdel-ghani-aissaoui",fullName:"Abdel Ghani Aissaoui",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/105795/images/system/105795.jpeg",biography:"Abdel Ghani AISSAOUI is a Full Professor of electrical engineering at University of Bechar (ALGERIA). He was born in 1969 in Naama, Algeria. He received his BS degree in 1993, the MS degree in 1997, the PhD degree in 2007 from the Electrical Engineering Institute of Djilali Liabes University of Sidi Bel Abbes (ALGERIA). He is an active member of IRECOM (Interaction Réseaux Electriques - COnvertisseurs Machines) Laboratory and IEEE senior member. He is an editor member for many international journals (IJET, RSE, MER, IJECE, etc.), he serves as a reviewer in international journals (IJAC, ECPS, COMPEL, etc.). He serves as member in technical committee (TPC) and reviewer in international conferences (CHUSER 2011, SHUSER 2012, PECON 2012, SAI 2013, SCSE2013, SDM2014, SEB2014, PEMC2014, PEAM2014, SEB (2014, 2015), ICRERA (2015, 2016, 2017, 2018,-2019), etc.). His current research interest includes power electronics, control of electrical machines, artificial intelligence and Renewable energies.",institutionString:"University of Béchar",institution:{name:"University of Béchar",country:{name:"Algeria"}}},{id:"99749",title:"Dr.",name:"Abdel Hafid",middleName:null,surname:"Essadki",slug:"abdel-hafid-essadki",fullName:"Abdel Hafid Essadki",position:null,profilePictureURL:"//cdnintech.com/web/frontend/www/assets/author.svg",biography:null,institutionString:null,institution:{name:"École Nationale Supérieure de Technologie",country:{name:"Algeria"}}},{id:"101208",title:"Prof.",name:"Abdel Karim",middleName:"Mohamad",surname:"El Hemaly",slug:"abdel-karim-el-hemaly",fullName:"Abdel Karim El Hemaly",position:null,profilePictureURL:"https://mts.intechopen.com/storage/users/101208/images/733_n.jpg",biography:"OBGYN.net Editorial Advisor Urogynecology.\nAbdel Karim M. A. El-Hemaly, MRCOG, FRCS � Egypt.\n \nAbdel Karim M. A. El-Hemaly\nProfessor OB/GYN & Urogynecology\nFaculty of medicine, Al-Azhar University \nPersonal Information: \nMarried with two children\nWife: Professor Laila A. Moussa MD.\nSons: Mohamad A. M. El-Hemaly Jr. MD. Died March 25-2007\nMostafa A. M. El-Hemaly, Computer Scientist working at Microsoft Seatle, USA. \nQualifications: \n1.\tM.B.-Bch Cairo Univ. June 1963. \n2.\tDiploma Ob./Gyn. Cairo Univ. April 1966. \n3.\tDiploma Surgery Cairo Univ. Oct. 1966. \n4.\tMRCOG London Feb. 1975. \n5.\tF.R.C.S. Glasgow June 1976. \n6.\tPopulation Study Johns Hopkins 1981. \n7.\tGyn. Oncology Johns Hopkins 1983. \n8.\tAdvanced Laparoscopic Surgery, with Prof. Paulson, Alexandria, Virginia USA 1993. \nSocieties & Associations: \n1.\t Member of the Royal College of Ob./Gyn. London. \n2.\tFellow of the Royal College of Surgeons Glasgow UK. \n3.\tMember of the advisory board on urogyn. FIGO. \n4.\tMember of the New York Academy of Sciences. \n5.\tMember of the American Association for the Advancement of Science. \n6.\tFeatured in �Who is Who in the World� from the 16th edition to the 20th edition. \n7.\tFeatured in �Who is Who in Science and Engineering� in the 7th edition. \n8.\tMember of the Egyptian Fertility & Sterility Society. \n9.\tMember of the Egyptian Society of Ob./Gyn. \n10.\tMember of the Egyptian Society of Urogyn. \n\nScientific Publications & Communications:\n1- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Asim Kurjak, Ahmad G. Serour, Laila A. S. Mousa, Amr M. Zaied, Khalid Z. El Sheikha. \nImaging the Internal Urethral Sphincter and the Vagina in Normal Women and Women Suffering from Stress Urinary Incontinence and Vaginal Prolapse. Gynaecologia Et Perinatologia, Vol18, No 4; 169-286 October-December 2009.\n2- Abdel Karim M. El Hemaly*, Laila A. S. Mousa Ibrahim M. Kandil, Fatma S. El Sokkary, Ahmad G. Serour, Hossam Hussein.\nFecal Incontinence, A Novel Concept: The Role of the internal Anal sphincter (IAS) in defecation and fecal incontinence. Gynaecologia Et Perinatologia, Vol19, No 2; 79-85 April -June 2010.\n3- Abdel Karim M. El Hemaly*, Laila A. S. Mousa Ibrahim M. Kandil, Fatma S. El Sokkary, Ahmad G. Serour, Hossam Hussein.\nSurgical Treatment of Stress Urinary Incontinence, Fecal Incontinence and Vaginal Prolapse By A Novel Operation \n"Urethro-Ano-Vaginoplasty"\n Gynaecologia Et Perinatologia, Vol19, No 3; 129-188 July-September 2010.\n4- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Laila A. S. Mousa and Mohamad A.K.M.El Hemaly.\nUrethro-vaginoplasty, an innovated operation for the treatment of: Stress Urinary Incontinence (SUI), Detursor Overactivity (DO), Mixed Urinary Incontinence and Anterior Vaginal Wall Descent. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/ urethro-vaginoplasty_01\n\n5- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamed M. Radwan.\n Urethro-raphy a new technique for surgical management of Stress Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/\nnew-tech-urethro\n\n6- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamad A. Rizk, Nabil Abdel Maksoud H., Mohamad M. Radwan, Khalid Z. El Shieka, Mohamad A. K. M. El Hemaly, and Ahmad T. El Saban.\nUrethro-raphy The New Operation for the treatment of stress urinary incontinence, SUI, detrusor instability, DI, and mixed-type of urinary incontinence; short and long term results. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=urogyn/articles/\nurethroraphy-09280\n\n7-Abdel Karim M. El Hemaly, Ibrahim M Kandil, and Bahaa E. El Mohamady. Menopause, and Voiding troubles. \nhttp://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly03/el-hemaly03-ss\n\n8-El Hemaly AKMA, Mousa L.A. Micturition and Urinary\tContinence. Int J Gynecol Obstet 1996; 42: 291-2. \n\n9-Abdel Karim M. El Hemaly.\n Urinary incontinence in gynecology, a review article.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/abs-urinary_incotinence_gyn_ehemaly \n\n10-El Hemaly AKMA. Nocturnal Enuresis: Pathogenesis and Treatment. \nInt Urogynecol J Pelvic Floor Dysfunct 1998;9: 129-31.\n \n11-El Hemaly AKMA, Mousa L.A.E. Stress Urinary Incontinence, a New Concept. Eur J Obstet Gynecol Reprod Biol 1996; 68: 129-35. \n\n12- El Hemaly AKMA, Kandil I. M. Stress Urinary Incontinence SUI facts and fiction. Is SUI a puzzle?! http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly/el-hemaly-ss\n\n13-Abdel Karim El Hemaly, Nabil Abdel Maksoud, Laila A. Mousa, Ibrahim M. Kandil, Asem Anwar, M.A.K El Hemaly and Bahaa E. El Mohamady. \nEvidence based Facts on the Pathogenesis and Management of SUI. http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly02/el-hemaly02-ss\n\n14- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Mohamad A. Rizk and Mohamad A.K.M.El Hemaly.\n Urethro-plasty, a Novel Operation based on a New Concept, for the Treatment of Stress Urinary Incontinence, S.U.I., Detrusor Instability, D.I., and Mixed-type of Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/urethro-plasty_01\n\n15-Ibrahim M. Kandil, Abdel Karim M. El Hemaly, Mohamad M. Radwan: Ultrasonic Assessment of the Internal Urethral Sphincter in Stress Urinary Incontinence. The Internet Journal of Gynecology and Obstetrics. 2003. Volume 2 Number 1. \n\n\n16-Abdel Karim M. El Hemaly. Nocturnal Enureses: A Novel Concept on its pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecolgy/?page=articles/nocturnal_enuresis\n\n17- Abdel Karim M. El Hemaly. Nocturnal Enureses: An Update on the pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecology/?page=/ENHLIDH/PUBD/FEATURES/\nPresentations/ Nocturnal_Enuresis/nocturnal_enuresis\n\n18-Maternal Mortality in Egypt, a cry for help and attention. The Second International Conference of the African Society of Organization & Gestosis, 1998, 3rd Annual International Conference of Ob/Gyn Department � Sohag Faculty of Medicine University. Feb. 11-13. Luxor, Egypt. \n19-Postmenopausal Osteprosis. The 2nd annual conference of Health Insurance Organization on Family Planning and its role in primary health care. Zagaziz, Egypt, February 26-27, 1997, Center of Complementary Services for Maternity and childhood care. \n20-Laparoscopic Assisted vaginal hysterectomy. 10th International Annual Congress Modern Trends in Reproductive Techniques 23-24 March 1995. Alexandria, Egypt. \n21-Immunological Studies in Pre-eclamptic Toxaemia. Proceedings of 10th Annual Ain Shams Medical Congress. Cairo, Egypt, March 6-10, 1987. \n22-Socio-demographic factorse affecting acceptability of the long-acting contraceptive injections in a rural Egyptian community. Journal of Biosocial Science 29:305, 1987. \n23-Plasma fibronectin levels hypertension during pregnancy. The Journal of the Egypt. Soc. of Ob./Gyn. 13:1, 17-21, Jan. 1987. \n24-Effect of smoking on pregnancy. Journal of Egypt. Soc. of Ob./Gyn. 12:3, 111-121, Sept 1986. \n25-Socio-demographic aspects of nausea and vomiting in early pregnancy. Journal of the Egypt. Soc. of Ob./Gyn. 12:3, 35-42, Sept. 1986. \n26-Effect of intrapartum oxygen inhalation on maternofetal blood gases and pH. Journal of the Egypt. Soc. of Ob./Gyn. 12:3, 57-64, Sept. 1986. \n27-The effect of severe pre-eclampsia on serum transaminases. The Egypt. J. Med. Sci. 7(2): 479-485, 1986. \n28-A study of placental immunoreceptors in pre-eclampsia. The Egypt. J. Med. Sci. 7(2): 211-216, 1986. \n29-Serum human placental lactogen (hpl) in normal, toxaemic and diabetic pregnant women, during pregnancy and its relation to the outcome of pregnancy. Journal of the Egypt. Soc. of Ob./Gyn. 12:2, 11-23, May 1986. \n30-Pregnancy specific B1 Glycoprotein and free estriol in the serum of normal, toxaemic and diabetic pregnant women during pregnancy and after delivery. Journal of the Egypt. Soc. of Ob./Gyn. 12:1, 63-70, Jan. 1986. Also was accepted and presented at Xith World Congress of Gynecology and Obstetrics, Berlin (West), September 15-20, 1985. \n31-Pregnancy and labor in women over the age of forty years. Accepted and presented at Al-Azhar International Medical Conference, Cairo 28-31 Dec. 1985. \n32-Effect of Copper T intra-uterine device on cervico-vaginal flora. Int. J. Gynaecol. Obstet. 23:2, 153-156, April 1985. \n33-Factors affecting the occurrence of post-Caesarean section febrile morbidity. Population Sciences, 6, 139-149, 1985. \n34-Pre-eclamptic toxaemia and its relation to H.L.A. system. Population Sciences, 6, 131-139, 1985. \n35-The menstrual pattern and occurrence of pregnancy one year after discontinuation of Depo-medroxy progesterone acetate as a postpartum contraceptive. Population Sciences, 6, 105-111, 1985. \n36-The menstrual pattern and side effects of Depo-medroxy progesterone acetate as postpartum contraceptive. Population Sciences, 6, 97-105, 1985. \n37-Actinomyces in the vaginas of women with and without intrauterine contraceptive devices. Population Sciences, 6, 77-85, 1985. \n38-Comparative efficacy of ibuprofen and etamsylate in the treatment of I.U.D. menorrhagia. Population Sciences, 6, 63-77, 1985. \n39-Changes in cervical mucus copper and zinc in women using I.U.D.�s. Population Sciences, 6, 35-41, 1985. \n40-Histochemical study of the endometrium of infertile women. Egypt. J. Histol. 8(1) 63-66, 1985. \n41-Genital flora in pre- and post-menopausal women. Egypt. J. Med. Sci. 4(2), 165-172, 1983. \n42-Evaluation of the vaginal rugae and thickness in 8 different groups. Journal of the Egypt. Soc. of Ob./Gyn. 9:2, 101-114, May 1983. \n43-The effect of menopausal status and conjugated oestrogen therapy on serum cholesterol, triglycerides and electrophoretic lipoprotein patterns. Al-Azhar Medical Journal, 12:2, 113-119, April 1983. \n44-Laparoscopic ventrosuspension: A New Technique. Int. J. Gynaecol. Obstet., 20, 129-31, 1982. \n45-The laparoscope: A useful diagnostic tool in general surgery. Al-Azhar Medical Journal, 11:4, 397-401, Oct. 1982. \n46-The value of the laparoscope in the diagnosis of polycystic ovary. Al-Azhar Medical Journal, 11:2, 153-159, April 1982. \n47-An anaesthetic approach to the management of eclampsia. Ain Shams Medical Journal, accepted for publication 1981. \n48-Laparoscopy on patients with previous lower abdominal surgery. Fertility management edited by E. Osman and M. Wahba 1981. \n49-Heart diseases with pregnancy. Population Sciences, 11, 121-130, 1981. \n50-A study of the biosocial factors affecting perinatal mortality in an Egyptian maternity hospital. Population Sciences, 6, 71-90, 1981. \n51-Pregnancy Wastage. Journal of the Egypt. Soc. of Ob./Gyn. 11:3, 57-67, Sept. 1980. \n52-Analysis of maternal deaths in Egyptian maternity hospitals. Population Sciences, 1, 59-65, 1979. \nArticles published on OBGYN.net: \n1- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Laila A. S. Mousa and Mohamad A.K.M.El Hemaly.\nUrethro-vaginoplasty, an innovated operation for the treatment of: Stress Urinary Incontinence (SUI), Detursor Overactivity (DO), Mixed Urinary Incontinence and Anterior Vaginal Wall Descent. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/ urethro-vaginoplasty_01\n\n2- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamed M. Radwan.\n Urethro-raphy a new technique for surgical management of Stress Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/\nnew-tech-urethro\n\n3- Abdel Karim M. El Hemaly, Ibrahim M Kandil, Mohamad A. Rizk, Nabil Abdel Maksoud H., Mohamad M. Radwan, Khalid Z. El Shieka, Mohamad A. K. M. El Hemaly, and Ahmad T. El Saban.\nUrethro-raphy The New Operation for the treatment of stress urinary incontinence, SUI, detrusor instability, DI, and mixed-type of urinary incontinence; short and long term results. \nhttp://www.obgyn.net/urogyn/urogyn.asp?page=urogyn/articles/\nurethroraphy-09280\n\n4-Abdel Karim M. El Hemaly, Ibrahim M Kandil, and Bahaa E. El Mohamady. Menopause, and Voiding troubles. \nhttp://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly03/el-hemaly03-ss\n\n5-El Hemaly AKMA, Mousa L.A. Micturition and Urinary\tContinence. Int J Gynecol Obstet 1996; 42: 291-2. \n\n6-Abdel Karim M. El Hemaly.\n Urinary incontinence in gynecology, a review article.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/abs-urinary_incotinence_gyn_ehemaly \n\n7-El Hemaly AKMA. Nocturnal Enuresis: Pathogenesis and Treatment. \nInt Urogynecol J Pelvic Floor Dysfunct 1998;9: 129-31.\n \n8-El Hemaly AKMA, Mousa L.A.E. Stress Urinary Incontinence, a New Concept. Eur J Obstet Gynecol Reprod Biol 1996; 68: 129-35. \n\n9- El Hemaly AKMA, Kandil I. M. Stress Urinary Incontinence SUI facts and fiction. Is SUI a puzzle?! http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly/el-hemaly-ss\n\n10-Abdel Karim El Hemaly, Nabil Abdel Maksoud, Laila A. Mousa, Ibrahim M. Kandil, Asem Anwar, M.A.K El Hemaly and Bahaa E. El Mohamady. \nEvidence based Facts on the Pathogenesis and Management of SUI. http://www.obgyn.net/displayppt.asp?page=/English/pubs/features/presentations/El-Hemaly02/el-hemaly02-ss\n\n11- Abdel Karim M. El Hemaly*, Ibrahim M. Kandil, Mohamad A. Rizk and Mohamad A.K.M.El Hemaly.\n Urethro-plasty, a Novel Operation based on a New Concept, for the Treatment of Stress Urinary Incontinence, S.U.I., Detrusor Instability, D.I., and Mixed-type of Urinary Incontinence.\nhttp://www.obgyn.net/urogyn/urogyn.asp?page=/urogyn/articles/urethro-plasty_01\n\n12-Ibrahim M. Kandil, Abdel Karim M. El Hemaly, Mohamad M. Radwan: Ultrasonic Assessment of the Internal Urethral Sphincter in Stress Urinary Incontinence. The Internet Journal of Gynecology and Obstetrics. 2003. Volume 2 Number 1. \n\n13-Abdel Karim M. El Hemaly. Nocturnal Enureses: A Novel Concept on its pathogenesis and Treatment.\nhttp://www.obgyn.net/urogynecolgy/?page=articles/nocturnal_enuresis\n\n14- Abdel Karim M. El Hemaly. 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