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Hazards Physiological Effects Leakage Currents Classes & Types Standards & Guidance Electrical Safety Test & Inspection General Points on Safety Bibliography
2.1 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. 2.2 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.
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.
realise that a patient in the clinical environment who may have electrical equipment intentionally connected to them and may also be anaesthetised is 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.
Leakage currents
Most safety testing regimes for medical electrical equipment involve the measurement of certain "leakage currents", because the level of them can help to verify whether or not a piece of equipment is electrically safe. In this section the various leakage currents that are commonly measurable with medical equipment safety testers are described and their significance discussed. The precise methods of measurement along with applicable safe limits are discussed later under paragraphs at 6.
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, 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 mains part (the transformer primary and so on) 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 minimised.
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).
There is no agreed symbol in use to indicate that equipment is class I and it is not mandatory to state on the equipment itself that it 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.
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 standards relating to safety of medical electrical equipment do not recognise Class III equipment since limitation of voltage is not deemed sufficient to ensure safety of the patient. All medical electrical equipment that is capable of mains connection must be classified as class I or class II. Medical electrical equipment having no mains connection is simply referred to as "internally powered".
BF
CF
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. In summary then, it should be understood that International Electrotechnical Commission (IEC) or British Standards (BS) manufacturers' standards for medical electrical equipment referred to below are intended only for type testing and should not be used for acceptance, in-service or routine testing of equipment. However, any tests that are used for the latter purposes should ideally be consistent with the standards to which the equipment has been manufactured. Routine tests and test limits may therefore be derived (in modified form) from the standards, with the strict proviso that any such tests should not damage or even stress the equipment under test.
5.2 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. The HTM was withdrawn on publication of BS5724 part 1 (see below).
BS 5724 part 1 was revised in 1989, making it identical to the International Electro-technical Commission standard IEC 601-1: 1988. 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 (see paragraphs at 5.6.1 below).
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 detailed inspection and test procedures to be performed on newly acquired medical electrical equipment before it was put into service. Inspection procedures were clearly explained and the standard acceptance test log sheet given in the appendix of the document contained 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).
document updates and replaces guidance previously given in DB9801 ("Medical device and Equipment Management for hospital and community based organisations") and its supplements. Section 4 of the new guidance addresses "Delivery of a new piece of equipment" and hence replaces guidance previously given in DB9801 Supplement 1. Having said that, much of the basic philosophy behind, and recommendations from, the latter document have been retained. The guidance stresses the importance of acceptance checks as a means of improving efficiency and reducing risk. It also emphasises the necessity of recording checks and test results in order to meet health and safety requirements, possible litigation demands and to enable safe and effective future device management. Delivery checks relevant to medical electrical equipment on delivery are divided into administrative tasks ("paperwork/database") and visual inspection. Recommended administrative checks and tasks include:
device compatibility with purchase specification inclusion and appropriateness of user and service instructions inclusion of compliance and calibration certificates and test results adding device details to equipment management records check for special requirements such as need for decontamination before use
The guidance further recommends that functional checks, electrical safety tests and calibration checks (where appropriate) should be carried out prior to the equipment being placed into service. No specific detail is given on safety tests, other than to emphasise that "pre-use tests should not exceed the bounds of normal use". In connection with this, it states that the tests described in IEC 60601-1 are "type tests" and are therefore not suitable for pre-use or maintenance tests (see paragraphs at 5.1 above). The guidance does, however, point out the legal requirements for electrical safety testing under the Health and Safety at Work etc Act 1974 and the Electricity at Work Regulations 1989. The guidance states that "Responsible organisations should ensure that they have implemented electrical safety testing procedures to comply with this legislation". The legal requirements are further discussed in these notes under paragraphs at 5.6 below. The full text of DB2006(05) is available free of charge on the MHRA website at www.mhra.gov.uk
5.6 UK Legislation
There are a number of items of legislation applicable in the UK that impact in a fairly direct way on maintenance procedures for medical electrical devices. These are discussed briefly below.
Particular requirements with regard to electrical equipment are imposed by the Electricity at Work Regulations 1989. Some significant extracts from the regulations are quoted below. It should be noted when reading them that the word "systems" refers to electrical installations and any equipment capable of being made live by them. Regulation 4(1) "All systems shall at all times be of such construction as to prevent, so far as is reasonably practicable, danger". Regulation 4(2) "As necessary to prevent danger, all systems shall be maintained so as to prevent, so far as is reasonably practicable, such danger". Regulation 4(3) "Every work activity, including operation, use and maintenance of a system and work near a system, shall be carried out in such a manner as not to give rise, so far as is reasonably practicable, to danger". Regulation 16 "No person shall be engaged in any work activity where knowledge or experience is necessary to prevent danger or, where appropriate, injury, unless he possesses such knowledge or experience, or is under such degree of supervision as may be appropriate having regard to the nature of the work." Although the Electricity at Work Regulations clearly put requirements on employers and employees with regard to the necessity for maintaining electrical safety, the means by which this should be done are not spelt out in the Regulations.
All medical electrical equipment should be marked by the manufacturer with one of the type symbols above.
The following paragraphs and diagrams describe the electrical safety tests commonly available on medical equipment safety testers. Please note that although HEI 95 and DB9801 are no longer current, they are referred to in the text since many medical electronics departments have used them as a basis for local acceptance testing and even routine testing protocols. Protocols based on both sets of guidance are also available on many medical equipment safety testers.
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. 6.3 Insulation Tests IEC 60601-1 (second edition), 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 recommended that for class I equipment the insulation resistance be measured at the mains plug between the live and neutral pins connected together and the earth pin. Whereas HEI 95 recommended using a 500V DC insulation tester, DB 9801 recommended the use of 350V DC as the test voltage. In practice this last requirement could prove difficult and it was 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 where mechanical on/off switches are present (see figure 9).
Class I, all types Not less than 50M Yes Yes Equipment containing mineral insulated heaters may give values down to 1M. Check equipment is switched on. Figure 9. Measurement of insulation resistance for class I equipment
HEI 95 further recommended 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 did not recommend any form of insulation test be applied to class II equipment.
Class II, all types having applied parts not less than 50M. No Yes Move probe to find worst case.
Satisfactory earth continuity and insulation test results indicate that it is safe to proceed to leakage current tests.
Class I equipment, all types 0.5mA in NC, 1mA in SFC or 5mA and 10mA respectively for equipment designed to IEC60601-1:2005. Yes, in normal condition only. Yes, in normal condition only. Measure with mains normal and reversed. Ensure equipment is switched on. Figure 12. Measurement of earth leakage current.
Hence, where higher earth leakage currents are recorded for equipment designed to the new standard, it is important to check the touch current under single fault condition, earth open circuit, from all accessible conductive parts.
Applicable to Class I and class II equipment, all types. Limits: 0.1mA in NC, 0.5mA in SFC DB9801 Yes, NC only recommended?: HEI 95 recommended?: Yes, class I SFC earth open circuit, class II NC. Ensure equipment switched on. Normal and reverse mains. Move probe to Notes: find worst case. Figure 13. Measurement of enclosure leakage current
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
Applicable to
Limits: DB9801 Yes, all types, normal condition only. recommended?: HEI 95 recommended?: Yes, type CF only, class I SFC earth open circuit, class II normal condition. quipment on, but outputs inactive. Normal and reverse mains. Limits are per Notes: electrode. Figure 15. Measurement of patient leakage current for each applied part in turn
Class I and class II, type CF (B & BF for DB9801 only) equipment having applied parts. 0.01mA in NC, 0.05mA in SFC.
Patient auxiliary current is measured between any single patient connection and all other patient connections of the same module or function connected together. Where all possible combinations are tested together with all possible single fault conditions this yields an exceedingly large amount of data of questionable value.
Applicable to
All classes and types of equipment having applied parts. Type B & BF - 0.1mA in NC, 0.5mA in SFC. Limits: Type CF - 0.01mA in NC, 0.05mA in SFC. DB9801 recommended?: No. HEI 95 recommended?: No. Notes: Ensure outputs are inactive. Normal and reverse mains. Figure 16. Measurement of patient auxiliary current.
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.
* 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.
As discussed at paragraphs under 5.6 above, user organisations should design and implement electrical safety inspection and test regimes on the basis of risk assessments. In practice, most user organisations have found it necessary to carry out electrical inspection and safety testing on medical electrical equipment on the following occasions. a. On newly acquired equipment prior to being accepted for use b. During routine planned preventative maintenance. c. 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 checks on the condition of packaging, presence of relevant documentation and accessories. However, it is useful to use the acceptance testing procedure to lay down baseline data for comparison when the equipment is tested on future scheduled services and after repairs.
open circuit. However, in most cases, if there is no problem with earth leakage current under normal condition, there is unlikely to be one under the single fault condition. Enclosure leakage and patient leakage currents are both recommended under this protocol to measured under single fault condition, earth open circuit (EOC). The rationale behind this is that any problems are likely to be evident under this condition and it is not improbable that the fault condition may arise when the equipment is in use. At the foot of the form, it is recorded whether the equipment has passed or failed in the light of the visual inspection and the electrical safety test results. The date of the test and the identity of the person who performed the test must also be recorded. The comments field below the table is a useful feature of any recording system. It allows any observations to be recorded, for example, of peculiarities of the equipment under test or concerns about test results. The record should be referred to by the person performing the next test and inspection on the equipment prior to carrying out the inspection and test.