Professional Documents
Culture Documents
Hazards Physiological Effects Leakage Currents Classes & Types Standards & Guidance Electrical Safety Test & Inspection General Points on Safety Bibliography
explosions. Although the use of flammable anaesthetics is not common today, it should be recognised that many of the medical gases currently in use, such oxygen or nitrous oxide, vigorously support combustion. Wherever there is an elevated concentration of such gases, there is an increased risk of fire initiated by electrical faults.
1.5 Infection
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.
1.6 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.
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.
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 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.
Hazards Physiological Effects Leakage Currents Classes & Types Standards & Guidance Electrical Safety Test & Inspection General Points on Safety Bibliography
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.
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
Hazards Physiological Effects Leakage Currents Classes & Types Standards & Guidance Electrical Safety Test & Inspection General Points on Safety Bibliography
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).
Certain changes in terminology and numbering systems have been introduced in order to make the standard more compatible with other IEC standards, in particular IEC 60950-1 (Information technology equipment). Collateral standards for medical electrical systems (IEC 60601-1-1) and programmable electrical medical systems (IEC 60601-1-4) have been incorporated into the body of the new standard as new clauses.
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 was 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 superseded HEI 95. The document was intended to be applicable to all newly delivered medical devices, including non-electrical equipment, before being placed into service. Delivery checks detailed included paperwork checks, visual inspection procedures and functional checks. Electrical safety checks and tests as well as calibration checks were also recommended. DB9801 Supplement 1 emphasised 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 involved shorting applied parts together or applying high voltages to electrodes. It was also suggested that medical electrical equipment not having applied parts could be safety tested satisfactorily using non-specialist portable appliance testers. Specimen forms for recording the results of checks and tests were given in the document. Rationales for the checks and tests prescribed were also given in the annexes of the document. DB0801 and its supplements were replaced by DB2006(05) in November 2006 (see below).
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.
higher risk devices (classes IIa, IIb and III), the assessment route is more rigorous and may include 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". Each notified body may be identified by a unique number that appears to the top right of the CE mark on medical devices. 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). The Medical Devices Directive is enshrined into UK law by the medical Devices Regulations 2002. 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.
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.
Hazards Physiological Effects Leakage Currents Classes & Types Standards & Guidance Electrical Safety Test & Inspection General Points on Safety Bibliography
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.
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 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. HEI 95 and DB9801 Supplement 1 recommended 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 Class I, all types Limit: 0.2 DB9801 recommended?: Yes, at 1A or less. HEI 95 recommended?: Yes, at 1A or less. Notes: Ensure probe is on a protectively earthed point Figure 8. Measurement of protective earth continuity.
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.
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.
Applicable to Class II, all types having applied parts Limits: not less than 50M. DB9801 recommended?: No HEI 95 recommended?: Yes Notes: 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.
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.
Notes:
Measure with mains normal and reversed. Ensure equipment is switched on. Figure 12. Measurement of earth leakage current.
Class I and class II equipment, all types. 0.1mA in NC, 0.5mA in SFC Yes, NC only 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
Applicable to Limits:
All classes, type B & BF equipment having applied parts. 0.1mA in NC, 0.5mA in SFC.
DB9801 recommended?: No HEI 95 recommended?: Yes, class I SFC earth open circuit, class II normal condition. Notes: Equipment on, but outputs inactive. Normal and reverse mains.
Figure 14. Measurement of patient leakage current with applied parts connected together
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. 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 electrode.
Figure 15. Measurement of patient leakage current for each applied part in turn
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 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
Notes:
Ensure outputs are inactive. Normal and reverse mains. Caution required, especially on physiological measurement equipment. Figure 17. Mains on applied parts measurement arrangement
Leakage current Earth Earth for fixed equipment Enclosure Patient Mains on applied part Patient auxiliary
* 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.
Measure between L and N connected together and E 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
Measure between applied parts and accessible conductive parts of the equipment. No recommendation. Limit > 50M. Investigate lower values Measure in normal condition Limit < 0.5mA Measure in SFC, earth open circuit for Class-1, NC for Class-II 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 : Measure in normal condition Limit < 0.5mA Measure in NC only Limit < 0.1 mA Measure from each applied part in turn, for all types of equipment Measure under NC only Limits
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
Type B & BF <0.1 mA per electrode Type CF < 0.01 per electrode
Hazards Physiological Effects Leakage Currents Classes & Types Standards & Guidance Electrical Safety Test & Inspection General Points on Safety Bibliography
The details of the test equipment used are also recorded at the top of the form together with the calibration date. This information is important for traceability since test results can only be proved to be accurate if it can be demonstrated that the test equipment was in calibration. The visual inspection checklist provides a record that the relevant parts of the equipment have been inspected. This is very important since, in practice, the visual inspection is likely to flag up problems far more often than the electrical safety tests themselves. It is also important that a record of visual inspection is kept. Where user organisations use electronic means to record data downloaded from electrical safety testers, it is important to add information on visual inspection to the record. The electrical safety tests that are used in this particular protocol are few in number and are the same tests, derived from IEC60601-1, that were selected for HEI 95. The earth continuity test is obviously important for all class I equipment. The insulation test is intended to look at the insulation between the mains part and the earth of the equipment under test, and may be regarded as a pre-test to verify that it is safe to apply mains power in order to measure leakage currents. Earth leakage current here is only measured under normal condition (NC). Note that "normal" and "reverse" here mean that the leakage current is measured with L1 and L2 the right way round and the wrong way round. Both of these conditions are defined as "normal condition". This test will not usually produce as high a reading as if the test is conducted with under single fault condition, neutral 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.
Hazards Physiological Effects Leakage Currents Classes & Types Standards & Guidance Electrical Safety Test & Inspection General Points on Safety Bibliography
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. Even under normal condition, the equipment under test cannot be regarded as safe, since the supplementary protection may have been compromised by the test arrangement. 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. Where it is not possible to remove equipment to a workshop facility for testing, particular care must be taken to ensure that there is no possibility of any other persons coming into contact with the equipment under test. 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, shortwave 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.