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1、American National Standard ANSI/AAMI/IEC 60601-2-21 Fax: (703) 525-1067. Printed in the United States of America ISBN 1570201315 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for R
2、esale, 03/21/2007 02:38:58 MDTNo reproduction or networking permitted without license from IHS -,-,- Contents Page Committee representation.v Backgroundvi Foreword.vii Introduction viii SECTION ONEGENERAL Clause 1Scope and object.1 2Terminology and definitions.2 3General requirements 3 4General requ
3、irements for tests 3 6Identification, marking and documents 3 SECTION TWOENVIRONMENTAL CONDITIONS 10Special environmental conditions 5 SECTION THREEPROTECTION AGAINST ELECTRIC SHOCK HAZARDS 20Dielectric strength5 SECTION FOURPROTECTION AGAINST MECHANICAL HAZARDS 21Mechanical strength.6 24Stability i
4、n NORMAL USE.6 SECTION FIVEPROTECTION AGAINST HAZARDS FROM UNWANTED OR EXCESSIVE RADIATION 33Infra-red radiation.6 36Electromagnetic compatibility 7 SECTION SIXPROTECTION AGAINST HAZARDS OF IGNITION OF FLAMMABLE ANAESTHETIC MIXTURES SECTION SEVENPROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SA
5、FETY HAZARDS 42Excessive temperature.7 43Fire prevention.7 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, sterilization and disinfection .8 46Human errors.9 49Interruption of the power supply.9 SECTION EIGHTACCURACY OF OPERATING DATA AND PROTECTION AGAINST HAZARDOUS OUTPUT 50
6、Accuracy of operating data 9 Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:38:58 MDTNo reproduction or networking permitted without license from IHS -,-,-
7、 SECTION NINEABNORMAL OPERATION AND FAULT CONDITIONS: ENVIRONMENTAL TESTS SECTION TENCONSTRUCTIONAL REQUIREMENTS 54General 11 56Components and general assembly 11 SECTION 101ADDITIONAL REQUIREMENTS 101Alarms12 102Sound pressure level .12 103Concentration of carbon dioxide (CO2) 13 Figures 101Test de
8、vice.14 102Layout of test devices 14 103Illustration of the main requirements of this standard15 Appendix/Annexes16 Appendix LReferencesPublications mentioned in this standard16 Annex AAGeneral guidance and rationale 17 Annex BBBibliography.21 Copyright Association for the Advancement of Medical Ins
9、trumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:38:58 MDTNo reproduction or networking permitted without license from IHS -,-,- 2000 AAMI ! ANSI/AAMI/IEC 60601-2-21 any IEC National Committee interested in the su
10、bject dealt with may participate in this preparatory work. International, governmental and non-governmental organizations liaising with the IEC also participate in this preparation. The IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditio
11、ns determined by agreement between the two organizations. 2) The formal decisions or agreements of the IEC on technical matters, prepared by technical committees on which all the National Committees having a special interest therein are represented, express, as nearly as possible, an international c
12、onsensus of opinion on the subjects dealt with. 3) They have the form of recommendations for international use published in the form of standards, technical reports or guides and they are accepted by the National Committees in that sense. 4) In order to promote international unification, IEC Nationa
13、l Committees undertake to apply IEC International Standards transparently to the maximum extent possible in their national and regional standards. Any divergence between the IEC Standard and the corresponding national or regional standard shall be clearly indicated in the latter. 5) The IEC provides
14、 no marking procedure to indicate its approval and cannot be rendered responsible for any equipment declared to be in conformity with one of its standards. International Standard IEC 60601-2-21 and its amendment have been prepared by subcommittee 62D: Electromedical equipment, of IEC technical commi
15、ttee 62: Electrical equipment in medical practice. The text of this Particular Standard and its amendment is based on the following documents: DIS/FDISReport on voting 62D(CO)7162D(CO)74 62D/195/FDIS62D/219/RVD Full information on the voting for the approval of this Particular Standard can be found
16、in the reports of voting indicated in the above table. Appendix L is an integral part of this standard. Annexes AA and BB are for information only. In this Particular Standard, the following print types are used: requirements, compliance with which can be tested, and definitions: in roman type; note
17、s, explanations, advice, instructions, general statements, exceptions and references: in smaller type; test specifications: in italic type; TERMS USED THROUGHOUT THE PARTICULAR STANDARD WHICH HAVE BEEN DEFINED IN CLAUSE 2 AND IN IEC 60601-1: SMALL CAPITALS. Copyright Association for the Advancement
18、of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:38:58 MDTNo reproduction or networking permitted without license from IHS -,-,- viii 2000 AAMI ! ANSI/AAMI/IEC 60601-2-21 where it is intended that an
19、y part of the General Standard, although possibly relevant, is not to be applied, a statement to that effect is given in this Particular Standard. The requirements of this Particular Standard take priority over those of the General Standard. Copyright Association for the Advancement of Medical Instr
20、umentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:38:58 MDTNo reproduction or networking permitted without license from IHS -,-,- 2 2000 AAMI ! ANSI/AAMI/IEC 60601-2-21 bb)disconnection of a SKIN TEMPERATURE SENSOR f
21、rom the EQUIPMENT; cc)failure of the heater control circuit. Additional subclause: 3.101For EQUIPMENT which combines alternative heat sources, for instance incubators with integrated radiant warmers, heated mattresses, etc., the safety requirements of the Particular Standards for these alternative h
22、eat sources, if any, shall be met. The safety requirements of this Particular Standard shall not be altered by such additional heat sources specified by the manufacturer, details of which are provided in the instruction for use. Compliance is checked by the test of clauses 42 and 56.6 of the relevan
23、t standards. 4General requirements for tests This clause of the General Standard applies except as follows: 4.5*Ambient temperature, humidity, atmospheric pressure a)*Amendment: In line 3 replace “an ambient temperature within the range 15 C to 35 C” by “an ambient temperature within the range 18 C
24、to 30 C”. 4.6Other conditions Additional item: aa)During the tests the CONTROL TEMPERATURE shall always exceed the ambient temperature by at least 3 C. 6Identification, marking and documents This clause of the General Standard applies except as follows: 6.1Marking on the outside of EQUIPMENT or EQUI
25、PMENT parts * Rationale, see annex AA. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:38:58 MDTNo reproduction or networking permitted without license from
26、 IHS -,-,- 4 2000 AAMI ! ANSI/AAMI/IEC 60601-2-21 -continue to perform its intended function as specified by the manufacturer or fail without creating a SAFETY HAZARD at a level less than or equal to 10 V/m for the frequency range of 26 MHz to 1 GHz. SECTION SIXPROTECTION AGAINST HAZARDS OF IGNITION
27、 OF FLAMMABLE ANAESTHETIC MIXTURES The clauses and subclauses of this section of the General Standard apply. SECTION SEVENPROTECTION AGAINST EXCESSIVE TEMPERATURES AND OTHER SAFETY HAZARDS The clauses and subclauses of this section of the General Standard apply except as follows: 42Excessive tempera
28、ture This clause of the General Standard applies except as follows: 42.1Amendment: Delete from column 1 in table Xa: “EQUIPMENT parts which may in NORMAL USE have a brief contact with a PATIENT”. Delete from column 2: “50 C”. 42.3*Amendment: Replace the first paragraph by the following: The temperat
29、ure of surfaces accessible to an infant PATIENT on the mattress shall not exceed 40 C for metal surfaces and 42 C for other materials when the EQUIPMENT is operating under STEADY TEMPERATURE CONDITION at its maximum CONTROL TEMPERATURE. Under conditions of warm-up to STEADY TEMPERATURE CONDITION or
30、that of a SINGLE FAULT CONDITION these surfaces shall not exceed 42 C for metal or 45 C for other materials. 42.5Addition: If the heater element surface temperature exceeds 85 C in NORMAL USE, heater guards which cannot exceed 85 C in NORMAL USE shall be fitted. Compliance is checked by measurement
31、of the temperature and by performing the rigidity test as described in 21 a) of the General Standard. The heater guard shall not touch the heater element. 43Fire prevention Add the following new subclauses: 43.101In order to eliminate the risk of oxygen fires caused by electrical components which ca
32、n be a source of ignition in enclosed compartments of EQUIPMENT containing an oxygen system, at least one of the following requirements shall apply: * Rationale, see annex AA. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Em
33、ployees/1111111001, User=Wing, Bernie Not for Resale, 03/21/2007 02:38:58 MDTNo reproduction or networking permitted without license from IHS -,-,- 8 2000 AAMI ! ANSI/AAMI/IEC 60601-2-21 -compartments containing electrical components shall be ventilated according to the requirements of 43.103; -elec
34、trical components which, in NORMAL USE or SINGLE FAULT CONDITION, can be a source of ignition shall comply with the requirements of 43.103. 43.102Any barrier required under the provisions of 43.101 shall be sealed at all joints and at any holes for cables or for other purposes. Compliance is checked
35、 by inspection and if applicable by the compliance test described in 40.5 of the General Standard, for enclosures with restricted breathing. The internal overpressure of 4 mbar specified in subclause 40.5 of the General Standard is not applicable when, in NORMAL CONDITION, a pressure difference exis
36、ts between the spaces separated by the barrier. In such cases the compliance test of 43.103 of this Particular Standard applies. 43.103The ventilation required under the provisions of 43.101 shall be such that the oxygen concentration in the compartment containing electrical components shall not exc
37、eed 4 vol. % above the ambient level. If this requirement is met by forced ventilation, means for an alarm in the event of malfunction shall be provided. Compliance is checked by the following test: The oxygen concentration shall be measured under the following conditions and for such a period that
38、the highest possible concentration of oxygen occurs. -SINGLE FAULT CONDITION including possible leakage of oxygen. -Selection of the most unfavorable control settings. -MAINS VOLTAGE deviations of 10%. The measurements shall be repeated after 4 h during which time the SUPPLY MAINS shall have been sw
39、itched off and the gas supply remained on. The rate of air exchange in the test room shall be between 3 volumes and 10 volumes per hour. 43.104* Electrical circuits which can produce sparks or generate increased surface temperatures and which might otherwise be a source of ignition shall be so desig
40、ned that no ignition occurs. At least both of the following requirements shall be satisfied in NORMAL CONDITION and SINGLE FAULT CONDITION: -the product of the r.m.s. value of the no load voltage and the r.m.s. value of the short circuit current shall not exceed 10 VA. -The surface temperature of co
41、mponents shall not exceed 300 C. Compliance is checked by the following test: Voltages and currents shall be measured or calculated and surface temperatures shall be measured in NORMAL CONDITIONS and SINGLE FAULT CONDITIONS. 44Overflow, spillage, leakage, humidity, ingress of liquids, cleaning, ster
42、ilization and disinfection This clause of the General Standard applies except as follows: 44.3Spillage Replacement: The EQUIPMENT shall be so constructed that in the event of spillage of water (accidental wetting) no safety hazard shall result from the ingress of water, the equipment shall meet the
43、dielectric strength requirements specified in 20.1 to 20.4 of the General Standard and the EQUIPMENT shall function normally. * Rationale, see annex AA. Copyright Association for the Advancement of Medical Instrumentation Provided by IHS under license with AAMI Licensee=IHS Employees/1111111001, Use
44、r=Wing, Bernie Not for Resale, 03/21/2007 02:38:58 MDTNo reproduction or networking permitted without license from IHS -,-,- 2000 AAMI ! ANSI/AAMI/IEC 60601-2-21 the latter could be cooler than nurseries. 6.8.2 aa) 8)It is desirable that the EQUIPMENT should be provided with an auditory alarm and vi
45、sual indication which operates when the SKIN TEMPERATURE SENSOR is detached from the infants skin. Technically this has not been reliably achieved and has therefore not been made a requirement of this Standard. 6.8.2 aa) 13)An INFANT RADIANT WARMER in the MANUAL MODE of operation emits a preset amou
46、nt of energy to the child continuously, regardless of the temperature of the infant. If the heater is set at the maximum in order to warm up the infant rapidly, the skin of the infant can become dangerously hot. It is therefore essential to attend to EQUIPMENT operation and infant condition at frequ
47、ent intervals. It is recommended that the PATIENT under the INFANT RADIANT WARMER be supervised. 6.8.2 aa) 15)The EQUIPMENT cannot differentiate between an increase in core temperature with a cold skin (fever) and a low core and skin temperature (hypothermia). Therefore in all situations it is recom
48、mended that the temperature of the PATIENT be monitored separately. 6.8.2 aa) 17)There have been reports of hot fragments (e.g., metal oxide particles) from aged warmer heaters falling onto the mattress. 33INFANT RADIANT WARMERS provide thermal support by directing invisible infra-red light to the infants body. The source of this infra-red light is an overhead heater whose electrical power input is limited by design, thereby limiting the amount of infra-red energy output that can be directed at the