Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

CHAPTER 1 INTRODUCTION

1.1 What are standards? The formal definition of a standard that should be adopted in the medical device domain is given by the ISO: Standards are documented agreements containing technical specifications or other precise criteria to be used consistently as rules, guidelines or definitions of characteristics, to ensure that materials, products, process and services are fit for their purpose. Types of specifications in standards Standards can establish a wide range of specifications for products, processes and services (see www.iso.org for definitions). 1. Prescriptive specifications obligate product characteristics, e.g. device dimensions, biomaterials, test or calibration procedures, as well as definitions of terms and terminologies. 2. Design specifications set out the specific design or technical characteristics of a product, e.g. operating room facilities or medical gas systems. 3. Performance specifications ensure that a product meets a prescribed test, e.g. strength requirements, measurement accuracy, battery capacity, or maximum defibrillator energy. 4. Management specifications set out requirements for the processes and procedures companies put in place, e.g. quality systems for manufacturing or environmental management systems. A standard may contain a combination of specifications. Prescriptive, design and performance specifications have been commonplace in standards. Management specifications are also rapidly gaining prominence. Recent years have seen the development and application of what are known as generic management system standards, where generic means that the standards requirements can be applied to any organization, regardless of the product it makes or the service it delivers, and management system refers to what the organization does to manage its processes. Two of the most widely known series of generic management system standards are the ISO 9000 series for managing quality systems, and the ISO 14000 series 1

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

for environmental management systems. Wide ranging information and assistance related to these standards and their application is available at www.iso.org. ISO13485 and ISO13488 are specific ISO quality systems standards for medical device manufacturing. Terms such as outcome-oriented standards, objectives standards, functionfocused standards and result-oriented standards are also employed. Essentially, these terms indicate that the standards specify the objectives (ends) to be achieved while leaving the methods (means) to the implementers. This can minimize possible constrictive effects of standards. 1. 2 Why do we need standards? Standards can serve different purposes. They can: 1. Provide reference criteria that a product, process or service must meet. 2. Provide information that enhances safety, reliability and performance of products, processes and services. 3. Assure consumers about reliability or other characteristics of goods or services provided in the marketplace. 4. Give consumers more choice by allowing one firms products to be sub stituted for, or combined with, those of another. Although we take for granted the advantage of being able to order shoes or clothes simply by referring to a size, this is only possible because manufacturers follow some industrial standards in making shoes and clothes. In contrast, incompatibility between electrical plugs and receptacles is a prime example of different countries failing to follow the same standards. When North Americans want to use a portable computer or other electrical appliance in Europe or Asia, they can be frustrated to find that the plug and voltage are not compatible. With the world becoming a global village, the need and benefits of standardization are becoming more and more important internationally for manufacturing, trade and communications. Quality systems and other management standards can provide common references to the kind of process, service or management practice expected. The Internet functions effectively because globally agreed-upon interconnection protocols exist. Global communication would be very difficult without international standardization. Health care workers are well aware of incompatible consumables or replacement partsin medical devices of similar function that are made by different manufacturers (e.g. IV set, X-ray cassettes). The lack of available consumables and repair parts is an important cause of medical equipment problems that are constantly encountered in developing countries. Most medical devices are used globally. The safety, performance and consistent quality of medical devices is, therefore, an

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

international public health interest. Thus, global harmonization of medical device standards and regulations is critical. 1.3 Voluntary and mandatory standards Most standards are voluntary. However, a standard may be mandated by a company, professional society, industry, government or trade agreement. A standard may be called a regulation when it becomes mandatory. This mandate may, or may not, have a legal basis. When a standard is mandated by a government or an international trade agreement, it normally becomes legally obligatory based on regulations or a law established by the government or the contracts between international bodies. Countries that are considering making standards mandatory should take into account the potential consequences under international agreements on technical barriers to trade. 1.4 Standards development process Figure 1 provides an example of the many steps used by standards development organizations (see www.iso.org for ISOs six-step process in the development of international standards). In general, good standards have the following attributes: 1. Their development has been overseen by a recognized body, thus ensuring that the process is transparent and not dominated by vested interests. 2. The development process has been open to input from all interested parties and the resulting document based on consensus. Consensus, in a practical sense, means that significant agreement among the stakeholders is reached in the preparation of the standard, including steps taken to resolve all objections.This process implies more than the votes of a majority, but not necessarily unanimity. 3. Good technical standards are based on consolidated results of science, technology and experience, and are aimed at the promotion of optimum community benefits. 4. Standards do not hinder innovations and must be periodically reviewed to remain in tune with technological advances.

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Figure 1. Typical standard for process development

1.5 Conformity assessment with standards There are four common industrial methods for assessing conformity to a standard. 1. A products conformity to standards is commonly assessed by direct testing. 2. A process can be assessed by audit. Certification organizations or regulatory authorities attest that products or processes conform to a standard by authorizing the display of their certification mark.

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

3. The conformity to management standard by an organization is known as management systems registration, a relatively new term used primarily in North America. Formally established audit procedures are followed by certified auditors who are supported by technical experts of the domain under audit. Management System Registration bodies (Registrars) issue registration certificates to companies that meet a management standard such as ISO9000, or to medical device manufacturers that meet the ISO13485/ISO9001 standards. Note that in North America, the term registration is used for an organization while certification is reserved for products. Many other countries use certification for both a product and an organization. 4. Accreditation is used by an authoritative body to give formal recognition that an organization or a person is competent to carry out a specific task. For example, in Europe, Notified Bodies are notified or accredited by the relevant State Competent Authority to carry out conformity assessment of medical devices. In Canada, a Quality System Registrar needs an accreditation from Health Canada before that Registrar begins assessing medical device manufacturers for conformity with quality system standards. The International Laboratory Accreditation Cooperation (ILAC) uses accreditation to provide formal recognition to competent laboratories around the world. 1.6 National and international standards systems A country may have many voluntary standards bodies. However, normally there is one official national organization that coordinates and accredits the standards development bodies in the country. This official national organization would have the authority to endorse a document as a national standard in accordance with official criteria, and it also represents the country in the various international standards organizations. In the United States, the American National Standards Institute (ANSI), a private, non-profit organization, is an official national organization. In Canada, it is the Standards Council of Canada (SCC), a crown (government) corporation. In Europe there is a committee composed of CEN (Comit Europen de Normalisation), CENELEC (the European Committee for Electrotechnical Standardization) and ETSI (the European Telecommunication Standards Institute) that supercedes the various European national standards bodies that were in place previously. For developing countries, reference to a standards system not only helps medical device administration, it is also important for other industrial and economic developments. International development agencies increasingly realize that a standardized infrastructure is a basic requirement for the success of economic policies that will improve productivity, market competitiveness and export capability. The three major international standardization organizations are the International

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Organization for Standardization (ISO), the International Electrotechnical Commission (IEC), and the International Telecommunication Union (ITU). Generally, ITU covers telecommunications, IEC covers electrical and electronic engineering, and ISO covers the remainder. For information technology, risk management, quality systems and many other areas, joint ISO/IEC technical committees manage standardization. Other organizations also produce documents on international standardization. Their documents are usually adopted by ISO/IEC/ITU as international standards if they have been developed in accordance with international consensus criteria. Any grouping of five member countries can also propose a standard to be considered by ISO for adoption as an international standard. Useful web sites include: www.iso.ch, www.IEC.ch, and www.itu.int/ for the ISO, IEC and ITU respectively. From here, links to national or regional standard organizations are indicated. 1.7 Identification of standards Standards are generally designated by an alphabetical prefix and a number. The letters (e.g. ISO, IEC, ANSI, CAN, EN, DIN) indicate the body that has approved them, while the numbers identify the specific standard and the year in which it was finalized. The standard reference code often gives an indication of adoption where standards are equivalent. For example: 1. CAN/CSA-Z386-94 means a standard developed in 1994 by the Canadian Standards Association (CSA, one of four accredited Canadian standards development organizations) and designated by the Standards Council of Canada (SCC) as a Canadian national standard. 2. ANSI/AAMI/ISO 15223:2000 means the international standard ISO 15223 (established in 2000) adopted by the Association for the Advancement of Medical Instrumentations in the United States, which in turn is designated by the American National Standards Institute (ANSI) as an American national standard. 3. UNI EN ISO 9001 indicates an Italian national standard (UNI) which is an adoption of a European standard (EN), which is itself an adoption of the International Standard ISO9001. 1.8 Current trends in the use of standards in medical device regulations Although a standard can be set and mandated by an authority, the current trend is for the adoption of voluntary standards established by consensus from all interested parties (the stakeholders). The use of voluntary standards originated from the realization that while regulations generally address the essential safety and performance principles, manufacturers and users still need to know detailed specifications pertaining to specific products. The provision of such specifications and detailed requirements for the multitude of devices presents an enormous

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

task for regulatory authorities. Fortunately, the wealth of voluntary standards already existing or being developed provide such precise specifications. The use of voluntary/consensus standards has many advantages including the following: 1. They are normally developed by experts with access to the vast resources available in the professional and industrial communities. 2. By taking advantage of such existing resources, the government can overcome its own limited resources for providing product specific technical requirements and characteristics. 3. Conformity to standards can also be assessed by an accredited third party (such as a notified body in Europe), which is a well-established industrial practice around the world. 4. The use of international standards facilitates harmonized regulatory processes and world trade, and thus improves global access to new technology. 5. As technology advances, it is much easier to update standards than to change regulations. Timely development and periodic revision by expert groups make medical device standards effective and efficient tools for supporting health care. 6. Manufacturers have the flexibility to choose appropriate standards or other means to demonstrate compliance with regulatory requirements. Regulatory authorities can recognize a standard, fully or partially, provided they clearly specify and publicize their intent. Several standards can also be recognized as a group to satisfy the requirements for a particular device. In some countries, the publication of government-recognized standards mandates product compliance. Medical devices intended for global use should follow international standards. For example, the ISO Technical Report (ISO 16142:2000) lists a number of significant international standards that may be suitable for demonstrating compliance with certain features of the essential principles of safety and performance of medical devices. The GHTF has issued the following recommendations regarding the recognition and use of standards: International standards are a building block for harmonized regulatory processes to assure the safety, quality and performance of medical devices. To achieve this purpose, the following principles are recommended: Regulatory Authorities and industry should encourage and support the development of international standards for medical devices to demonstrate

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

compliance with the Essential Principles of Safety and Performance of Medical Devices (GHTF document SG1 NO20R5 referred to hereafter as the Essential Principles). Regulatory Authorities developing new medical device regulations should encourage the use of international standards. Regulatory Authorities should provide a mechanism for recognizing international standards to provide manufacturers with a method of demonstrating compliance with the Essential Principles. When an international standard is not applied or not applied in full, this is acceptable if an appropriate level of compliance with the Essential Principles can be demonstrated. While it may be preferable for harmonization purposes to use international standards, it may be appropriate for Regulatory Authorities to accept the use of national/regional standards or industry standards as a means of demonstrating compliance. Standards Bodies developing or revising standards for use with medical devices should consider the suitability of such standards for demonstrating compliance with the Essential Principles and to identify which of the Essential Principles they satisfy. The use of standards should preferably reflect current, broadly applicable technology while not discouraging the use of new technologies. Standards may represent the current state of the art in a technological field. However, not all devices, or elements of device safety and/or performance may be addressed by recognized standards, especially for new types of devices and emerging technologies.

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

CHAPTER 2 : SAFETY TESTING OF MEDICAL EQUIPMENT

2.1 Hazards of Medical Electrical Equipment Medical electrical equipment can present a range of hazards to the patient, the user, or to service personnel. Many such hazards are common to many or all types of medical electrical equipment, whilst others are peculiar to particular categories of equipment. Listed below are various types of common hazards. 2.1 Mechanical Hazards All types of medical electrical equipment can present mechanical hazards. These can range from insecure fittings of controls to loose fixings of wheels on equipment trolleys. The former may prevent a piece of life supporting equipment from being operated properly, whilst the latter could cause serious accidents in the clinical environment. Such hazards may seem too obvious to warrant mentioning, but it is unfortunately all too common for such mundane problems to be overlooked while more exotic problems are addressed. 2.2 Risk of fire or explosion All mains powered electrical equipment can present the risk of fire in the event of certain faults occurring such as internal or external short circuits. In certain environments such fires may cause explosions. Although the use of explosive anaesthetic gases is not common today, it should be recognised that many of the medical gases in use vigorously support combustion. 2.3 Absence of Function Since many pieces of medical electrical equipment are life supporting or monitor vital functions, the absence of function of such a piece of equipment would not be merely inconvenient, but could threaten life. 2.4 Excessive or insufficient output In order to perform its desired function equipment must deliver its specified output. Too high an output, for example, in the case of surgical diathermy units, would clearly be hazardous. Equally, too low an output would result in inadequate therapy, which in turn may delay patient recovery, cause patient injury or even death. This highlights the importance of correct calibration procedures. 9

Safety in Biomedical Engineering (KUEU 4130) 2.5 Infection

Prof. Ir. Dr Fatimah Ibrahim

Medical equipment that has been inadequately decontaminated after use may cause infection through the transmission of microorganisms to any person who subsequently comes into contact with it. Clearly, patients, nursing staff and service personnel are potentially at risk here. 2.6 Misuse Misuse of equipment is one of the most common causes of adverse incidents involving medical devices. Such misuse may be a result of inadequate user training or of poor user instructions. 2.7 Risk of exposure to spurious electric currents All electrical equipment has the potential to expose people to the risk of spurious electric currents. In the case of medical electrical equipment, the risk is potentially greater since patients are intentionally connected to such equipment and may not benefit from the same natural protection factors that apply to people in other circumstances. Whilst all of the hazards listed are important, the prevention of many of them require methods peculiar to the particular type of equipment under consideration. For example, in order to avoid the risk of excessive output of surgical diathermy units, knowledge of radio frequency power measurement techniques is required. However, the electrical hazards are common to all types of medical electrical equipment and can minimised by the use of safety testing regimes which can be applied to all types of medical electrical equipment. For these reasons, it is the electrical hazards that are the main topic of this session.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

CHAPTER 3 : PHYSIOLOGICAL EFFECTS OF ELECTRICITY

3.1 Electrolysis The movement of ions of opposite polarities in opposite directions through a medium is called electrolysis and can be made to occur by passing DC current through body tissues or fluids. If a DC current is passed through body tissues for a period of minutes, ulceration begins to occur. Such ulcers, while not normally fatal, can be painful and take long periods to heal. 3.2 Burns When an electric current passes through any substance having electrical resistance, heat is produced. The amount of heat depends on the power dissipated (I2R). Whether or not the heat produces a burn depends on the current density. Human tissue is capable of carrying electric current quite successfully. Skin normally has a fairly high electrical resistance while the moist tissue underneath the skin has a much lower resistance. Electrical burns often produce their most marked effects near to the skin, although it is fairly common for internal electrical burns to be produced, which, if not fatal, can cause long lasting and painful injury. 3.3 Muscle cramps When an electrical stimulus is applied to a motor nerve or a muscle, the muscle does exactly what it is designed to do in the presence of such a stimulus i.e. it contracts. The prolonged involuntary contraction of muscles (tetanus) caused by an external electrical stimulus is responsible for the phenomenon where a person who is holding an electrically live object can be unable to let go. 3.4 Respiratory arrest The muscles between the ribs (intercostal muscles) need to repeatedly contract and relax in order to facilitate breathing. Prolonged tetanus of these muscles can therefore prevent breathing. 3.5 Cardiac arrest The heart is a muscular organ, which needs to be able to contract and relax repetitively in order to perform its function as a pump for the blood. Tetanus of the heart musculature will prevent the pumping process.

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Safety in Biomedical Engineering (KUEU 4130) 3.6 Ventricular fibrillation

Prof. Ir. Dr Fatimah Ibrahim

The ventricles of the heart are the chambers responsible for pumping blood out of the heart. When the heart is in ventricular fibrillation, the musculature of the ventricles undergoes irregular, uncoordinated twitching resulting in no net blood flow. The condition proves fatal if not corrected in a very short space of time. Ventricular fibrillation can be triggered by very small electrical stimuli. A current as low as 70 mA flowing from hand to hand across the chest, or 20A directly through the heart may be sufficient. It is for this reason that most deaths from electric shock are attributable to the occurrence of ventricular fibrillation. 3.7 Effect of frequency on neuro -muscular stimulation The amount of current required to stimulate muscles is dependent to some extent on frequency. Referring to figure 1, it can be seen that the smallest current required to prevent the release of an electrically live object occurs at a frequency of around 50 Hz. Above 10 kHz the neuro-muscular response to current decreases almost exponentially.

Figure 1. Current required to prevent release of a live object.

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Safety in Biomedical Engineering (KUEU 4130) 3.8 Natural protection factors

Prof. Ir. Dr Fatimah Ibrahim

Many people have received electric shocks from mains potentials and above and lived to tell the tale. Part of the reason for this is the existence of certain natural protection factors. Ordinarily, a person subject to an unexpected electrical stimulus is protected to some extent by automatic and intentional reflex actions. The automatic contraction of muscles on receiving an electrical stimulus often acts to disconnect the person from the source of the stimulus. Intentional reactions of the person receiving the shock normally serve the same purpose. It is important to realise that a patient in the clinical environment who may have electrical equipment intentionally connected to them and may also be anaesthetised are relatively unprotected by these mechanisms. Normally, a person who is subject to an electric shock receives the shock through the skin, which has a high electrical resistance compared to the moist body tissues below, and hence serves to reduce the amount of current that would otherwise flow. Again, a patient does not necessarily enjoy the same degree of protection. The resistance of the skin may intentionally have been lowered in order to allow good connections of monitoring electrodes to be made or, in the case of a patient undergoing surgery, there may be no skin present in the current path. The absence of natural protection factors as described above highlights the need for stringent electrical safety specifications for medical electrical equipment and for routine test and inspection regimes aimed at verifying electrical safety.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

CHAPTER 4: LEAKAGE CURRENTS

4.1 Causes of leakage currents If any conductor is raised to a potential above that of earth, some current is bound to flow from that conductor to earth. This is true even of conductors that are well insulated from earth, since there is no such thing as perfect insulation or infinite impedance. The amount of current that flows depends on: a. b. c. the voltage on the conductor. the capacitive reactance between the conductor and earth. the resistance between the conductor and earth.

The currents that flow from or between conductors that are insulated from earth and from each other are called leakage currents, and are normally small. However, since the amount of current required to produce adverse physiological effects is also small, such currents must be limited by the design of equipment to safe values. For medical electrical equipment, several different leakage currents are defined according to the paths that the currents take.

4.2 Earth leakage current Earth leakage current is the current that normally flows in the earth conductor of a protectively earthed piece of equipment. In medical electrical equipment, very often, the mains is connected to a transformer having an earthed screen. Most of the earth leakage current finds its way to earth via the impedance of the insulation between the transformer primary and the inter-winding screen, since this is the point at which the insulation impedance is at its lowest (see figure 2).

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Figure 2. Earth leakage current path. Under normal conditions, a person who is in contact with the earthed metal enclosure of the equipment and with another earthed object would suffer no adverse effects even if a fairly large earth leakage current were to flow. This is because the impedance to earth from the enclosure is much lower through the protective earth conductor than it is through the person. However, if the protective earth conductor becomes open circuited, then the situation changes. Now, if the impedance between the transformer primary and the enclosure is of the same order of magnitude as the impedance between the enclosure and earth through the person, then a shock hazard exists. It is a fundamental safety requirement that in the event of a single fault occurring, such as the earth becoming open circuit, no hazard should exist. It is clear that in order for this to be the case in the above example, the impedance between the transformer primary and the enclosure needs to be high. This would be evidenced when the equipment is in the normal condition by a low earth leakage current. In other words, if the earth leakage current is low then the risk of electric shock in the event of a fault is reduced.

4.3 Enclosure leakage current Enclosure leakage current is defined as the current that flows from an exposed conductive part of the enclosure to earth through a conductor other than the protective earth conductor. However, if a protective earth conductor is connected to the enclosure, there is little point in attempting to measure the enclosure leakage current from another protectively earthed point on the enclosure since any measuring device used is effectively shorted out by the low resistance of the protective earth. Equally, there is little point in measuring the enclosure leakage current from a protectively earthed point on the enclosure with the protective earth open circuit, since this would give the same reading as measurement of earth leakage current as described above. For these reasons, it is usual when

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

testing medical electrical equipment to measure enclosure leakage current from points on the enclosure that are not intended to be protectively earthed (see figure 3). On many pieces of equipment, no such points exist. This is not a problem. The test is included in test regimes to cover the eventuality where such points do exist and to ensure that no hazardous leakage currents will flow from them.

Figure 3. Enclosure leakage current path.

4.4 Patient leakage current Patient leakage current is the leakage current that flows through a patient connected to an applied part or parts. It can either flow from the applied parts via the patient to earth or from an external source of high potential via the patient and the applied parts to earth. Figures 4a and 4b illustrate the two scenarios.

Figure 4a. Patient leakage current path from equipment.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Figure 4b. Patient leakage current path to equipment.

4.5 Patient auxiliary current The patient auxiliary current is defined as the current that normally flows between parts of the applied part through the patient, which is not intended to produce a physiological effect (see figure 5).

Figure 5. Patient auxiliary current path.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

CHAPTER 5: CLASSES AND TYPE OF MEDICAL ELECTRICAL EQUIPMENT

All electrical equipment is categorised into classes according to the method of protection against electric shock that is used. For mains powered electrical equipment there are usually two levels of protection used, called "basic" and "supplementary" protection. The supplementary protection is intended to come into play in the event of failure of the basic protection. 5.1 Class I equipment Class I equipment has a protective earth. The basic means of protection is the insulation between live parts and exposed conductive parts such as the metal enclosure. In the event of a fault that would otherwise cause an exposed conductive part to become live, the supplementary protection (i.e. the protective earth) comes into effect. A large fault current flows from the mains part to earth via the protective earth conductor, which causes a protective device (usually a fuse) in the mains circuit to disconnect the equipment from the supply. It is important to realise that not all equipment having an earth connection is necessarily class I. The earth conductor may be for functional purposes only such as screening. In this case the size of the conductor may not be large enough to safely carry a fault current that would flow in the event of a mains short to earth for the length of time required for the fuse to disconnect the supply. Class I medical electrical equipment should have fuses at the equipment end of the mains supply lead in both the live and neutral conductors, so that the supplementary protection is operative when the equipment is connected to an incorrectly wired socket outlet. Further confusion can arise due to the use of plastic laminates for finishing equipment. A case that appears to be plastic does not necessarily indicate that the equipment is not class I. There is no agreed symbol in use to indicate that equipment is class I. Where any doubt exists, reference should be made to equipment manuals. The symbols below may be seen on medical electrical equipment adjacent to terminals.

Figure 6. Symbols seen on earthed equipment. 18

Safety in Biomedical Engineering (KUEU 4130) 5.2 Class II equipment

Prof. Ir. Dr Fatimah Ibrahim

The method of protection against electric shock in the case of class II equipment is either double insulation or reinforced insulation. In double insulated equipment the basic protection is afforded by the first layer of insulation. If the basic protection fails then supplementary protection is provided by a second layer of insulation preventing contact with live parts. Reinforced insulation is defined in standards as being a single layer of insulation offering the same degree of protection as double insulation. Class II medical electrical equipment should be fused at the equipment end of the supply lead in either mains conductor or in both conductors if the equipment has a functional earth. The symbol for class II equipment is two concentric squares indicating double insulation as shown below.

Figure 7. Symbol for class II equipment. 5.3 Class III equipment Class III equipment is defined as that in which protection against electric shock relies on the fact that no voltages higher than safety extra low voltage (SELV) are present. SELV is defined in turn in the relevant standard as a voltage not exceeding 25V ac or 60V dc. In practice such equipment is either battery operated or supplied by a SELV transformer. If battery operated equipment is capable of being operated when connected to the mains (for example, for battery charging) then it must be safety tested as either class I or class II equipment. Similarly, equipment powered from a SELV transformer should be tested in conjunction with the transformer as class I or class II equipment as appropriate. It is interesting to note that the current IEC standard relating to safety of medical electrical equipment does not recognise Class III equipment since limitation of voltage is not deemed sufficient to ensure safety of the patient.

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Safety in Biomedical Engineering (KUEU 4130) 5.4 Equipment types

Prof. Ir. Dr Fatimah Ibrahim

As described above, the class of equipment defines the method of protection against electric shock. The degree of protection for medical electrical equipment is defined by the type designation. The reason for the existence of type designations is that different pieces of medical electrical equipment have different areas of application and therefore different electrical safety requirements. For example, it would not be necessary to make a particular piece medical electrical equipment safe enough for direct cardiac connection if there is no possibility of this situation arising. Table 1 shows the symbols and definitions for each type classification of medical electrical equipment. Type Symbol B Definition Equipment providing a particular degree of protection against electric shock, particularly regarding allowable leakage currents and reliability of the protective earth connection (if present). As type B but with isolated or floating (F - type) applied part or parts. Equipment providing a higher degree of protection against electric shock than type BF, particularly with regard to allowable leakage currents, and having floating applied parts.

BF

CF

Table 1. Medical electrical equipment types

All medical electrical equipment should be marked by the manufacturer with one of the type symbols above.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

CHAPTER 6: TESTING REGIMES AND RELEVANT DOCUMENTATION

6.1 Type tests and routine tests Before discussing the documentation relevant to electrical safety of medical electrical equipment, it is important to distinguish between "type tests" and routine tests. Standards for the manufacture of equipment normally detail tests which are intended to be carried out on a single representative sample of a piece of equipment for which certification of compliance with a standard is being sought. Such tests are carried out by approved test houses under tightly specified environmental conditions. These tests are called "type tests" and are not intended for routine use. Indeed, repetition of many of the tests would certainly cause deterioration in performance and safety of the equipment under test. Routine tests have an entirely different purpose than that for type tests. Routine tests are intended to provide good indicators to the safety of equipment without subjecting it to undue stress that would be liable to cause deterioration. 6.2 HTM 8 In 1963 the Department of Health and Social Security published Hospital Technical Memorandum number 8 called "safety code for electro-medical apparatus". The purpose of the document was to establish adequate standards for the design and construction of electro-medical apparatus since no other relevant national standard existed at the time. Although the document was produced essentially for the guidance of manufacturers, biomedical departments in hospitals were quick to adopt tests from the document for the basis of their own medical electrical equipment safety testing regimes. Although tests detailed in the code were type tests, many of them could be fairly easily be repeated without adverse effects on the equipment as routine tests. Performance of the electrical safety tests was made easier by the development of specialised medical equipment safety testers, specifically, the Liverpool tester. 6.3 BS 5724 or IEC 60601 In 1979, BS 5724 part 1 was published. This document is a comprehensive specification for safety of medical electrical equipment. Part 1 covers the general requirements, i.e requirements common to all medical electrical equipment regardless of function. A series of part 2's detailing particular requirements for specific categories of medical electrical equipment followed publication of part 1.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

BS 5724 is a far more detailed document than HTM 8, which it replaced. Like the HTM, the tests contained in the standard are type tests. Some guidance was given in the 1979 edition of the standard on recommended testing during manufacture and/or installation. Unfortunately, some routine test regimes based on BS 5724 tended to be too rigorous for such application and in some cases caused damage to equipment. BS 5724 part 1 was revised in 1989, making it identical to the International Electro-technical Committee standard IEC 601 part 1. References to routine tests were made even less specific than in the previous edition. The standard was subsequently re-numbered as IEC 60601-1. Any manufacturer obtaining compliance of an item of their equipment to BS5724 or IEC 60601 will be in possession of a uniquely numbered certificate issued by the test house verifying that fact. Compliance to the standard is a commonly used route used by manufacturers to obtain CE marking. 6.4 Hospital Equipment Information 95 In August 1981, the DHSS issued HEI 95 entitled "Code of practice for acceptance testing of medical electrical equipment". The document was produced partly to address the problems that had arisen due to the misapplication of type tests from BS 5724 by some NHS biomedical departments. As indicated by the title of the document, the code of practice details inspection and test procedures to be performed on newly acquired medical electrical equipment before it is put into service. Inspection procedures are clearly explained and the standard acceptance test log sheet given in the appendix of the document contains references to the explanatory text. The electrical safety testing recommendations offered in HEI 95 provided a testing regime that was effective whilst being considerably simpler than many test regimes that were developed from the recommendations of BS 5724. The reason for this is that the recommended electrical safety tests are generally applied under worst-case conditions. Although designed as a code of practice for acceptance testing the document has been widely adopted and used as the basis of routine test regimes by hospital biomedical departments. The document was officially withdrawn in December 1999 on the publication by the Medical Devices Agency of MDA DB9801 Supplement 1 (see below).

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Safety in Biomedical Engineering (KUEU 4130) 6.5 DB9801 Supplement 1

Prof. Ir. Dr Fatimah Ibrahim

In December 1999, the Medical Devices Agency (now the Medicines and Healthcare Products Regulatory Agency or MHRA) published Device Bulletin 9801 Supplement 1 entitled "Checks and tests for newly delivered medical devices". The document is a supplement to Device Bulletin 9801, "Medical device and equipment management for hospital and community based organisations", which was published by the Medical Devices Agency in January 1998. The supplement supersedes HEI 95 as well as HEI 140 (see 5.9 below) for in vitro diagnostic medical devices. The document is intended to be applicable to all newly delivered medical devices, including equipment which is not electrical, before the equipment is placed into service. Delivery checks detailed include paperwork checks, visual inspection procedures and functional checks. Electrical safety checks and tests as well as calibration checks are also recommended. DB9801 Supplement 1 emphasises that new equipment under test should not be subjected to currents or voltages exceeding those experienced under normal operating conditions. Hence none of the recommended tests involve shorting applied parts together or applying high voltages to electrodes. It is also suggested that medical electrical equipment not having applied parts can be safety tested satisfactorily using a non-specialist portable appliance tester. Specimen forms for recording the results of checks and tests are given in the document. Rationales for the checks and tests prescribed are given in the annexes of the document. 6.6 Medical Devices Directive Since the Medical Devices Directive (Council Directive 93/42/EEC) became law in the UK in 1994, it has been mandatory that all medical devices put on to the market are appropriately CE marked to indicate compliance with the directive. An important component of the directive is a list of "essential requirements" to which all medical devices must comply. Compliance with these requirements can be interpreted essentially as meaning that the medical device is fit for purpose. Depending on the risk class under which a particular medical device is classified, there are various means by which a manufacturer is able to demonstrate conformity with the directive. For devices in the lowest risk category (class I), self declaration is acceptable, whilst for medium risk devices (classes IIa and IIb), the assessment route normally includes auditing of the manufacturers quality assurance system and independent type testing to a recognised standard (e.g. IEC 60601) of a representative production sample by a "notified body".

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

In each member state a "Competent Authority" is authorised by that country's government to ensure that the requirements of the directive are carried out. In the UK, the competent authority is the Secretary of State for Health who has delegated day to day running of the competent authority to the Medicines and Healthcare Products Regulatory Agency (MHRA). As far as the purchaser of equipment is concerned, all medical devices purchased within any EEC member state should be appropriately CE marked. Conformity to the directive should be confirmed by the equipment supplier by means of a "declaration of conformity" prior to purchase. 6.7 ESCHLE The Electrical Safety Code for Hospital Laboratory Equipment (ESCHLE) was first published in 1977. It was produced by the Department of Health in conjunction with industry as a minimum standard to ensure the safety of laboratory equipment used in hospital pathology departments and similar environments. This was done in response to pressure from industry since prior to ESCHLE there was no strictly appropriate standard to form the basis for design and assessment of hospital laboratory equipment. Hospital Technical Memorandum 8, which was a safety code for electromedical apparatus was used for this purpose prior to 1977. In 1986 the second edition of ESCHLE was published by the Department of Health in Hospital Equipment Information 158 (HEI158). The title ESCHLE is somewhat misleading since apart from electrical safety, the document is also designed to ensure safety from overheating, fire, mechanical hazards, and the provision of adequate documentation and clearly marked controls. In HEI165 (March 1987) the DHSS recommended that as from January 1989, only laboratory equipment complying to ESCHLE II should be purchased by the NHS. However, ESCHLE itself recognised that some equipment used in hospital laboratories may comply to other standards applicable to specific types of equipment (e.g. BS4743/IEC348 for electronic measuring apparatus). It was recognised that on publication of the IEC 1010 standard in 1990 (see below), ESCHLE would "die a natural death". 6.8 IEC 61010 In 1990 the International Electrotechnical Committee published IEC1010-1 (subsequently re-numbered as IEC 61010-1), which is a European standard covering safety requirements for electrical equipment for measurement control and laboratory use. Part 1 deals with requirements relevant to all types of equipment under its remit and a series of part 2's covers particular requirements for specific types of equipment. The standard has been adopted by the British

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Standards Institution (BS EN 61010-1:2001 is the current edition) and has effectively replaced ESCHLE. The purpose of the standard is to provide adequate protection to the operator and the surrounding area against electric shock or burn, mechanical hazards, excessive temperature, fire, effects of radiation, liberated gases, explosion and implosion. However, it should be noted that IEC61010-1 is not specifically intended for hospital applications of laboratory equipment. 6.9 Hospital Equipment Information 140 Part II of HEI140 is virtually an equivalent to HEI95 except that it is designed for hospital laboratory equipment. Part I of the document summarised the implementation of the first edition of ESCHLE and added some amendments to that standard. Again, although HEI140 Part II is a code of practice for acceptance testing, it is highly relevant to routine testing and has been widely used for this purpose. The document was written with ESCHLE in mind but was still considered to be a relevant code of practice for equipment complying to IEC61010, since no equivalent document relating specifically to that standard was produced. MDA DB9801 Supplement 1 is stated to replace HEI 140 part II for in-vitro medical diagnostic medical devices from December 1999, "pending further guidance in this area". No guidance has been given by the Medical devices Agency as to the status of HEI 140 with regard to hospital laboratory equipment that is not classified as an in-vitro diagnostic device. In March 2002, the MDA published Device Bulletin DB2002(02) "Management of in-vitro diagnostic medical devices". Although this document gives some general guidance on the need for acceptance testing, it does provide any specific detail on appropriate electrical safety tests. 6.10 When to test Medical electrical equipment should be inspected and tested on the following occasions. a. b. c. On newly acquired equipment prior to being accepted for use During routine planned preventative maintenance. After repairs have been carried out on equipment.

A patient should never be connected to a piece of equipment that has not been checked. The testing regime used in the case of acceptance testing will be slightly different to that used on other occasions particularly as regards condition of packaging, 25

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

presence of relevant documentation and accessories. Having said this, the importance of visual inspection prior to all electrical testing cannot be over stressed. Most equipment that has become hazardous or defective due to damage exhibits visible signs of such. 6.11 Recording test results The acceptance test log sheet given in appendix A of HEI 95 is a good example of a comprehensive format for its purpose and many biomedical departments have used it successfully or modified it slightly to suit their own requirements. Log sheets for routine safety testing are generally less extensive since the bulk of the information they need to record relates purely to the electrical safety tests. Examples of forms in use are given in appendix 2. One important feature of such forms is that they should allow changes in results over a period to be seen at a glance. This facility enhances the usefulness of routine safety testing since it can often allow developing problems to be spotted before they present a hazard. 6.12 Equipment Management Software Packages There are on the market a number of equipment management software packages suitable for use with medical electrical equipment. SEMS and QA-MAP are some such packages. Some software packages allow the downloading of test results from automatic testers to a database and the production of hard copy test result forms. These facilities can be very useful if used correctly although there are also inherent dangers. Computers are able to handle large amounts of information very quickly and the temptation exists with automatic testers to perform large numbers of tests and store all results on computer. Such information is of no use whatever if there is no human contact with the information. This may seem to be stating the obvious, but where large amounts of information are presented, it becomes very easy to miss important details.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

CHAPTER 7: ELECTRICAL SAFETY TESTS

7.1 Normal condition and single fault conditions A basic principle behind the philosophy of electrical safety is that in the event of a single abnormal external condition arising or of the failure of a single means of protection against a hazard, no safety hazard should arise. Such conditions are called "single fault conditions" (SFC's) and include such situations as the interruption of the protective earth conductor or of one supply conductor, the appearance of an external voltage on an applied part, the failure of basic insulation or of temperature limiting devices. Where a single fault condition is not applied, the equipment is said to be in "normal condition" (NC). However, it is important to understand that in this condition, the performance of certain tests may compromise the means of protection against electric shock. For example, if earth leakage current is measured in normal condition, the impedance of the measuring device in series with the protective earth conductor means that there is no effective supplementary protection against electric shock. Many electrical safety tests are carried out under single fault conditions since these represent the worst case and will give the most adverse results. Clearly the safety of the equipment under test may be compromised when such tests are performed. Personnel carrying out electrical safety tests should be aware that the normal means for protection against electric shock are not necessarily operative during testing and should therefore exercise due precautions for their own safety and that of others.

7.2 Protective Earth Continuity The resistance of the protective earth conductor is measured between the earth pin on the mains plug and a protectively earthed point on the equipment enclosure (see figure 6). The reading should not normally exceed 0.2 O at any such point. The test is obviously only applicable to class I equipment. In IEC60601, the test is conducted using a 50Hz current between 10A and 25A for a period of at least 5 seconds. Although this is a type test, some medical equipment safety testers mimic this method. Damage to equipment can occur if high currents are passed to points that are not protectively earthed, for example, functional earths. Great care should be taken when high current testers are used to ensure that the probe is connected to a point that is intended to be protectively earthed.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

HEI 95 and DB9801 Supplement 1 recommend that the test be carried out at a current of 1A or less for the reason described above. Where the instrument used does not do so automatically, the resistance of the test leads used should be deducted from the reading. If protective earth continuity is satisfactory then insulation tests can be performed.

Applicable to Limit: DB9801 recommended?: HEI 95 recommended?: Notes:

Class I, all types 0.2 Yes, at 1A or less. Yes, at 1A or less. Ensure probe is on a protectively earthed point

Figure 8. Measurement of protective earth continuity.

7.3 Insulation Tests IEC 60601-1, clause 17, lays down specifications for electrical separation of parts of medical electrical equipment compliance to which is essentially verified by inspection and measurement of leakage currents. Further tests on insulation are detailed under clause 20, "dielectric strength". These tests use AC sources to test equipment that has been pre-conditioned to specified levels of humidity. The tests described in the standard are type tests and are not suitable for use as routine tests. HEI 95 and DB9801 recommend that for class I equipment the insulation resistance is measured at the mains plug between the live and neutral pins

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

connected together and the earth pin. Whereas HEI 95 recommends using a 500V DC insulation tester, DB 9801 recommends the use of 350V DC as the test voltage. In practice this last requirement could prove difficult and it is acknowledged in a footnote that a 500 V DC test voltage is unlikely to cause any harm. The value obtained should normally be in excess of 50M but may be less in exceptional circumstances. For example, equipment containing mineral insulated heaters may have an insulation resistance as low as 1M with no fault present. The test should be conducted with all fuses intact and equipment switched on (see figure 9).

Applicable to Class I, all types Limits: Not less than 50M DB9801 Yes recommended?: HEI 95 Yes recommended?: Equipment containing mineral insulated heaters may give Notes: values down to 1M. Check equipment is switched on. Figure 9. Measurement of insulation resistance for class I equipment

HEI 95 further recommends for class II equipment that the insulation resistance be measured between all applied parts connected together and any accessible conductive parts of the equipment. The value should not normally be less than 50M (see figure 10). DB9801 Supplement 1 does not recommend any form of insulation test be applied to class II equipment.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Applicable to Limits: DB9801 recommended?: HEI 95 recommended?: Notes:

Class II, all types having applied parts not less than 50M. No Yes Move probe to find worst case.

Figure 10. Measurement of insulation resistance for class II equipment.

Satisfactory earth continuity and insulation test results indicate that it is safe to proceed to leakage current tests.

7.4 Leakage current measuring device The leakage current measuring device recommended by IEC 60601-1 loads the leakage current source with a resistive impedance of about 1 kO and has a half power point at about 1kHz. The recommended measuring device was changed slightly in detail between the 1979 and 1989 version but remained functionally very similar. Figure 11 shows suitable arrangements for the measuring device. The millivolt meter used should be true RMS reading and should have an input impedance greater than 1 M. In practice this is easily achievable with most good quality modern multimeters. The meter in the arrangements shown measures 1mV for each A of leakage current.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Figure 11. Suitable arrangements for measurement of leakage currents.

7.5 Earth Leakage Current For class I equipment, earth leakage current is measured as shown in figure 12. The current should be measured with the mains polarity normal and reversed. HEI 95 and DB9801 Supplement 1 recommend that the earth leakage current be measured in normal condition (NC) only. Many safety testers offer the opportunity to perform the test under a single fault condition such as live or neutral conductor open circuit.

Applicable to Limits: DB9801 recommended?: HEI recommended?: Notes:

Class I equipment, all types 0.5mA in NC, 1mA in SFC or 5mA and 10mA respectively for permanently installed equipment. Yes, in normal condition only. 95 Yes, in normal condition only. Measure with mains normal and reversed. Ensure equipment is switched on.

Figure 12. Measurement of Earth Leakage Current.

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Safety in Biomedical Engineering (KUEU 4130) 7.6 Enclosure leakage current

Prof. Ir. Dr Fatimah Ibrahim

Enclosure leakage current is measured between an exposed part of the equipment which is not intended to be protectively earthed and true earth as shown in figure 13. The test is applicable to both class I and class II equipment and should be performed with mains polarity both normal and reversed. HEI 95 recommends that the test be performed under the SFC protective earth open circuit for class I equipment and under normal condition for class II equipment. DB9801 Supplement 1 recommends that the test be carried out under normal condition only for both class I and class II equipment. Many safety testers also allow the SFC's of interruption of live or neutral conductors to be selected. Points on class I equipment which are likely not to be protectively earthed may include front panel fascias, handle assemblies etc.

Applicable to Limits: DB9801 recommended?: HEI recommended?: Notes:

Class I and class II equipment, all types. 0.1mA in NC, 0.5mA in SFC Yes, NC only 95 Yes, class I SFC earth open circuit, class II NC. Ensure equipment switched on. Normal and reverse mains. Move probe to find worst case.

Figure 13. Measurement of Enclosure Leakage Current.

7.7 Patient leakage current Under IEC 60601-1 and HEI 95, for class I and class II type B and BF equipment, the patient leakage current is measured from all applied parts having the same function connected together and true earth (figure 14). For type CF equipment 32

Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

the current is measured from each applied part in turn and the leakage current leakage must not be exceeded at any one applied part (figure 15). DB9801 Supplement 1 recommends that patient leakage current be measured from each applied part in turn for all types of equipment, although the recommended leakage current limits have not been revised to take into account the changed test method for B and BF equipment. Great care must be taken when performing patient leakage current measurements that equipment outputs are inactive. In particular, outputs of diathermy equipment and stimulators can be fatal and can damage test equipment.

Applicable to Limits: DB9801 recommended?: HEI 95 recommended?: Notes:

All classes, type B & BF equipment having applied parts. 0.1mA in NC, 0.5mA in SFC. No Yes, class I SFC earth open circuit, class II normal condition. Equipment on but outputs inactive. Normal and reverse mains.

Figure 14. Measurement of Patient Leakage Current with applied parts connected together.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Applicable to Limits: DB9801 recommended?: HEI recommended?: Notes:

Class I and class II, type CF (B & BF for DB9801 only) equipment having applied parts. 0.01mA in NC, 0.05mA in SFC. Yes, all types, normal condition only. 95 Yes, type CF only, class I SFC earth open circuit, class II normal condition. Equipment on but outputs inactive. Normal and reverse mains. Limits are per electrode.

Figure 15. Measurement of patient leakage current for each applied part in turn

7.8 Patient auxiliary current Patient auxiliary current as defined in section 3.5 is measured between any single patient connection and all other patient connections of the same module connected together. It is not usual to test all possible combinations since together with all possible single fault conditions this would give an exceedingly large amount of data of questionable value.

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

Applicable to Limits:

All classes and types of equipment having applied parts. Type B & BF - 0.1mA in NC, 0.5mA in SFC. Type CF - 0.01mA in NC, 0.05mA in SFC.

DB9801 No. recommended?: HEI 95 recommended?: No. Ensure outputs are inactive. Normal and reverse Notes: mains.

Figure 16. Measurement of patient auxiliary current.

7.9 Mains on applied parts By applying mains voltage to the applied parts, the leakage current that would flow from an external source into the patient circuits can be measured. The measuring arrangement is illustrated in figure 18. Although the safety tester normally places a current limiting resistor in series with the measuring device for the performance of this test, a shock hazard still exists. Therefore, great care should be taken if the test is carried out in order to avoid the hazard presented by applying mains voltage to the applied parts. Careful consideration should be given as to the necessity or usefulness of performing this test on a routine basis when weighed against the associated hazard and the possibility of causing problems with equipment. The purpose of the test under IEC 60601-1 is to ensure that there is no danger of electric shock to a patient who for some unspecified reason is raised to a potential above earth due to the connection of the applied parts of the equipment under test. The standard requires that the leakage current limits specified are not exceeded. There is no guarantee that equipment performance will not be adversely affected by the performance of the test. In particular, caution should be exercised in the case of sensitive physiological measurement equipment. In short, the test is a "type test".

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Safety in Biomedical Engineering (KUEU 4130) Applicable to Limit: DB9801 recommended?: HEI 95 recommended?: Notes:

Prof. Ir. Dr Fatimah Ibrahim

Class I & class II, types BF & CF having applied parts. Type BF - 5mA; type CF - 0.05mA per electrode. No. No Ensure outputs are inactive. Normal and reverse mains. Caution required, especially on physiological measurement equipment.

Figure 17. Mains on applied parts measurement arrangement.

7.10 Leakage current summary The following table summarises the leakage current limits (in mA) specified by IEC60601-1 for the tests most commonly performed as routine tests. Limits for DB9801 recommended tests are underlined. Limits for HEI 95 recommended tests are given in bold type. Type B NC 0.5 fixed 5 0.1 0.1 SFC 1 10 0.5 0.5 0.5 Type BF NC 0.5 5 0.1 0.1 0.1 SFC 1 10 0.5 0.5 5 0.5 Type CF NC 0.5 5 0.1 0.01 0.01 SFC 1 10 0.5 0.05 0.05 0.05

Leakage current Earth Earth for equipment Enclosure Patient

Mains on applied part Patient auxiliary 0.1

* For class II type CF equipment HEI95 recommends a limit for enclosure leakage current of 0.01mA as per the 1979 edition of BS 5724. Table 2. Leakage current limits summary.

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Safety in Biomedical Engineering (KUEU 4130) 7.11 Comparison recommendations Test Earth continuity of HEI HEI 95 95 and DB

Prof. Ir. Dr Fatimah Ibrahim 9801 Supplement 1

DB9801 Supplement 1

Use test current of 1A or Use test current of 1A or less less Limit 0.2ohm Limit 0.2ohm Class Measure between L and N connected together and E 1 using 500v DC tester. Limit > 50M. Investigate lower values Measure between L and N connected together and E using 350v DC tester. Limit > 20M. Investigate lower values

Insulation for equipment

Insulation for equipment

Class

Measure between applied parts and accessible II conductive parts of the No recommendation. equipment. Limit > 50M. Investigate lower values Measure in condition Limit < 0.5mA normal Measure in condition Limit < 0.5mA normal

Earth leakage current

Measure in SFC, earth open circuit for Class-1, Measure in NC Enclosure leakage current NC for Class-II Limit < 0.1 mA Limit <0.5 mA for Class1 <0.1 mA for class II Measure from all applied parts connected together for B & BF equipment and from each applied part in turn for type CF. Measure under SFC, eart open circuit for Class 1, NC for classII. Limits : Patient leakage current Class I, B& BF < 0.5 mA Class II, B& BF < 0.1 mA Class I, CF < 0.05 mA per electrode Class II, CF < 0.01 mA per electrode

only

Measure from each applied part in turn, for all types of equipment Measure under NC only Limits Type B & BF <0.1 mA per electrode Type CF < 0.01 per electrode

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Safety in Biomedical Engineering (KUEU 4130)

Prof. Ir. Dr Fatimah Ibrahim

CHAPTER 8: GENERAL POINT ON SAFETY

Many Electrical safety tests are performed under single fault conditions such that a means for protection against electric shock has been removed. In the case of patient leakage current with mains on applied parts, a hazard is actually introduced. For these reasons no equipment under test should be touched whilst tests are being undertaken, as parts of the equipment may be hazardous live. For similar reasons, tests should be conducted on suitable non-conductive surfaces and conductive objects should be kept well clear of the equipment. The potential hazard is exacerbated by the use of automatic testers when running in automatic or semi-automatic modes since hazardous voltages may appear on the equipment under test at any time without any warning. Many categories of medical electrical equipment can produce outputs for treatment purposes that, if applied incorrectly to a person can prove fatal, or at least cause serious injuries. Examples of these categories include surgical diathermy machines, nerve and muscle stimulators, short-wave therapy units and defibrillators. Persons who have not had specific training on such equipment sufficient to enable them to avoid the hazards should not be allowed to perform electrical safety testing on it. The tests applied in the course of routine safety testing can cause damage to equipment if carried out incorrectly or inappropriately. Such damage may lead directly or indirectly to patient injuries or death if the equipment is put back into service in this condition. It is clear that only maintenance personnel who are sufficiently trained to avoid such occurrences arising should carry out electrical safety testing of medical equipment.

References 1. Note adopted from http://www.ebme.co.uk/arts/safety/part7.htm 2. World Health Organization (WHO), Medical Devices Regulations: Global overview and guiding principle

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