ANSI TIR62296-2009 Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements.pdf

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1、ANSI/AAMI/IEC TIR62296:2009 Association for the Advancementof Medical InstrumentationConsiderations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals fornew requirementsAn ANSI Technical Report prepared by AAMI ANSI/AAMI/IEC TIR62296:2009 (Revision of ANSI/AAMI/IEC TIR

2、62296:2003) Considerations of unaddressed safety aspects in the second edition of IEC 60601-1 and proposals for new requirements Approved 17 March 2009 by Association for the Advancement of Medical Instrumentation Approved 5 April 2009 by American National Standards Institute, Inc. Abstract: This Te

3、chnical Report contains a series of recommendations developed by an expert working group of IEC subcommittee 62A in response to questions of interpretation of the second edition of IEC 60601-1. This Technical Report is primarily intended to be used by manufacturers of MEDICAL ELECTRICAL EQUIPMENT; t

4、est houses and others responsible for assessment of compliance with IEC 60601-1; and those developing subsequent editions of IEC 60601-1. The object of this Technical Report is to make the recommendations/interpretations developed by the experts in IEC/SC 62A/WG 14 available to those interested in t

5、he application of the second edition of IEC 60601-1. Keywords: electromedical equipment, interpretations, safety, testing Published by Association for the Advancement of Medical Instrumentation 1110 N. Glebe Road, Suite 220 Arlington, VA 22201-4795 www.aami.org 2009 by the Association for the Advanc

6、ement of Medical Instrumentation All Rights Reserved This publication is subject to copyright claims of IEC, ANSI, and AAMI. No part of this publication may be reproduced or distributed in any form, including an electronic retrieval system, without the prior written permission of AAMI. All requests

7、pertaining to this document should be submitted to AAMI. It is illegal under federal law (17 U.S.C. 101, et seq.) to make copies of all or any part of this document (whether internally or externally) without the prior written permission of the Association for the Advancement of Medical Instrumentati

8、on. Violators risk legal action, including civil and criminal penalties, and damages of $100,000 per offense. For permission regarding the use of all or any part of this document, contact AAMI, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. Phone: (703) 525-4890; Fax: (703) 525-1067. Print

9、ed in the United States of America ISBN 1570203458 AAMI Technical Information Report A technical information report (TIR) is a publication of the Association for the Advancement of Medical Instrumentation (AAMI) Standards Board that addresses a particular aspect of medical technology. Although the m

10、aterial presented in a TIR might need further evaluation by experts, releasing the information is valuable because the industry and the professions have an immediate need for it. A TIR differs markedly from a standard or recommended practice, and readers should understand the differences between the

11、se documents. Standards and recommended practices are subject to a formal process of committee approval, public review, and resolution of all comments. This process of consensus is supervised by the AAMI Standards Board and, in the case of American National Standards, by the American National Standa

12、rds Institute. A TIR is not subject to the same formal approval process as a standard. However, a TIR is approved for distribution by a technical committee and the AAMI Standards Board. Another difference is that, although both standards and TIRs are periodically reviewed, a standard must be acted o

13、nreaffirmed, revised, or withdrawnand the action formally approved usually every five years but at least every 10 years. For a TIR, AAMI consults with a technical committee about five years after the publication date (and periodically thereafter) for guidance on whether the document is still usefult

14、hat is, to check that the information is relevant or of historical value. If the information is not useful, the TIR is removed from circulation. A TIR may be developed because it is more responsive to underlying safety or performance issues than a standard or recommended practice or because achievin

15、g consensus is extremely difficult or unlikely. Unlike a standard, a TIR permits the inclusion of differing viewpoints on technical issues. CAUTION NOTICE: This AAMI TIR may be revised or withdrawn at any time. Because it addresses a rapidly evolving field or technology, readers are cautioned to ens

16、ure that they have also considered information that might be more recent than this document. All standards, recommended practices, technical information reports, and other types of technical documents developed by AAMI are voluntary, and their application is solely within the discretion and professi

17、onal judgment of the user of the document. Occasionally, voluntary technical documents are adopted by government regulatory agencies or procurement authorities, in which case the adopting agency is responsible for enforcement of its rules and regulations. Comments on this technical information repor

18、t are invited and should be sent to AAMI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI Technical Report. Publication of this ANSI Technical Report h

19、as been approved by the accredited standards developer (AAMI). This document is registered as a Technical Report series of publications according to the Procedures for the Registration of Technical Reports with ANSI. This document is not an American National Standard and the material contained herei

20、n is not normative in nature. Comments on the content of this document should be sent to AAMI, Attn: Standards Department, 1110 N. Glebe Road, Suite 220, Arlington, VA 22201-4795. CONTENTS Glossary of equivalent standards . vi Committee representation.viii Background of AAMI adoption of IEC/TR 62296

21、:2009 . ix FOREWORD x INTRODUCTION xii 1 Scope and object .1 1.1 Scope .1 1.2 Object.1 2 Recommendations2 2.1 Summary of all recommendations prepared by SC 62A/WG 14.2 2.2 Recommendation sheets .4 2.2.1 Separation: Reliability of component impedance.4 2.2.2 Separation: Non-complying creepage distanc

22、e and air clearances 6 2.2.3 Mains supply transformers: Overload test.7 2.2.4 Mains supply transformers: Short circuit and overload tests8 2.2.5 Creepage distance and air clearances: Values .9 2.2.6 Dielectric strength 10 2.2.7 Failure of components: Evidence of reliability. 11 2.2.8 ENCLOSURES and

23、protective covers. 12 2.2.9 INTERNALLY POWERED EQUIPMENT: 110 % of the maximum supply voltage . 13 2.2.10 Creepage distances and air clearances: Values under 1 mm. 14 2.2.11 Separation: Secondary circuit impedance limit LEAKAGE CURRENT 15 2.2.12 ENCLOSURES and PROTECTIVE COVERS: Lampholder/switching

24、 device . 16 2.2.13 Fixing, prevention of maladjustment: Torque test 17 2.2.14 Batteries not intended to be changed by OPERATOR: Lithium batteries . 18 2.2.15 Excessive temperatures: Ambient temperatures . 19 2.2.16 Continuous LEAKAGE CURRENTS: Different SUPPLY MAINS 20 2.2.17 ENCLOSURE and protecti

25、ve covers: EQUIPMENT in ambulances . 21 2.2.18 Dielectric strength: Voltages appearing from external sources 22 2.2.19 Testing switch mode power supply units (SMPSU) 23 2.2.20 Failure of an electrical component: Time periodicity for detection 25 2.2.21 Environmental conditions: Compliance paragraph.

26、 26 2.2.22 Limitation of voltage and/or energy: Capacitance 27 2.2.23 LEAKAGE CURRENTS: Presence of 45 k resistor in Figure 21. 28 2.2.24 Humidity preconditioning treatment: Exception from requirement 29 2.2.25 Dielectric strength: EQUIPMENT containing floating circuits. 30 2.2.26 General requiremen

27、ts for tests: Measurement uncertainty 31 2.2.27 CREEPAGE DISTANCES and AIR CLEARANCES: Interpolated values . 32 2.2.28 Overheating: Change of load resistance. 33 2.2.29 Mains operated EQUIPMENT with additional power source: Integrity of external protective earth 34 2.2.30 Rechargeable batteries: No

28、OPERATOR/USER maintenance. 35 2.2.31 Isolation from the SUPPLY MAINS: Symbol for single pole switch . 36 2.2.32 Sequence of testing: Clause 52 before Clause 19. 37 2.2.33 SINGLE FAULT CONDITION: ENCLOSURE LEAKAGE CURRENT from INTERNALLY POWERED EQUIPMENT 38 2.2.34 Marking on the outside of EQUIPMENT

29、: Type and rating of fuses. 39 2.2.35 Excessive temperatures: APPLIED PARTS not intended to supply heat. 40 2.2.36 Mains supply transformers: Use of PTCs as protective devices. 41 2.2.37 Components and general assembly: Reliability of components 42 2.2.38 Definition of APPLIED PART: EQUIPMENT worn b

30、y PATIENTS. 43 2.2.39 Construction: Triple insulated winding wire. 44 2.2.40 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test versus CREEPAGE DISTANCES and AIR CLEARANCES . 45 2.2.41 CREEPAGE DISTANCES and AIR CLEARANCES: Dielectric strength test versus CREEPAGE DISTANCES and AIR CLEA

31、RANCES POWER SUPPLY CORDS 46 2.2.42 ACCOMPANYING DOCUMENTS: on CD-ROM or electronic file format 47 2.2.43 INTERNAL ELECTRICAL POWER SOURCE: Requirements for lithium batteries . 48 2.2.44 Dielectric strength: Differences between B-d and B-e . 49 2.2.45 Excessive temperatures: Thermocouple instead of

32、resistance method 50 2.2.46 Mains fuses and OVER-CURRENT RELEASEs: Fuses in CLASS II EQUIPMENT 51 2.2.47 Plug in power supply 52 2.2.48 Connecting cords between EQUIPMENT parts: Other applications 53 2.2.49 MULTIPLE PORTABLE SOCKET-OUTLET 54 2.2.50 Separation, DEFIBRILLATION-PROOF APPLIED PART: mult

33、iple APPLIED PARTS. 55 2.2.51 Separation, APPLIED PART: Hand held flexible shafts 56 2.2.52 Protective earthing: No-load voltage of 6 V maximum . 57 2.2.53 Foot-operated control devices: Protection against entry of liquids . 58 2.2.54 Mains supply transformers . 59 2.2.55 Dielectric strength: Reliab

34、ility of components to bridge A-a2and B-a 60 2.2.56 Dielectric strength: A-e in switch mode power supply units (SMPSU) 61 2.2.57 Dielectric strength: Connection of 12 V dc negative side to ENCLOSURE . 62 2.2.58 Dielectric strength: Voltages appearing on SIP/SOP . 63 2.2.59 APPLIED PART: EQUIPMENT wi

35、thout APPLIED PART 64 2.2.60 Scope: Other than MEDICAL ELECTRICAL EQUIPMENT in contact with the body of a person 65 2.2.61 Markings: AC symbol . 66 2.2.62 Interruption of power supply: Characteristics of interruption 67 2.2.63 Reference voltage: Different reference voltages in the same circuit. 68 B

36、ibliography . 69 Index of Terms . 71 vi 2009 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR62296:2009 Glossary of equivalent standards International Standards adopted in the United States may include normative references to other International Standards. For each Intern

37、ational Standard that has been adopted by AAMI (and ANSI), the table below gives the corresponding U.S. designation and level of equivalency to the International Standard. NOTE: Documents are sorted by international designation. Other normatively referenced International Standards may be under consi

38、deration for U.S. adoption by AAMI; therefore, this list should not be considered exhaustive. International designation U.S. designation Equivalency IEC 60601-1:2005 ANSI/AAMI ES60601-1:2005 Major technical variations IEC 60601-1-2:2007 ANSI/AAMI/IEC 60601-1-2:2007 Identical IEC 60601-2-2:2009 ANSI/

39、AAMI/IEC 60601-2-2:2009 Identical IEC 60601-2-4:2002 ANSI/AAMI DF80:2003 Major technical variations IEC 60601-2-19:2009 ANSI/AAMI/IEC 60601-2-19:2009 Identical IEC 60601-2-20:2009 ANSI/AAMI/IEC 60601-2-20:2009 Identical IEC 60601-2-21:2009 ANSI/AAMI/IEC 60601-2-21:2009 Identical IEC 60601-2-24:1998

40、ANSI/AAMI ID26:2004 Major technical variations IEC 60601-2-47:2001 ANSI/AAMI EC38:2007 Major technical variations IEC 60601-2-50:2009 ANSI/AAMI/IEC 60601-2-50:2009 Identical IEC 80601-2-58:2008 ANSI/AAMI/IEC 80601-2-58:2008 Identical IEC/TR 60878:2009 ANSI/AAMI/IEC TIR60878:2003 Identical IEC/TR 622

41、96:2009 ANSI/AAMI/IEC TIR62296:2009 Identical IEC 62304:2006 ANSI/AAMI/IEC 62304:2006 Identical IEC/TR 62348:2006ANSI/AAMI/IEC TIR62348:2006 Identical ISO 5840:2005 ANSI/AAMI/ISO 5840:2005 Identical ISO 7198:1998 ANSI/AAMI/ISO 7198:1998/2001/(R)2004 Identical ISO 7199:1996 ANSI/AAMI/ISO 7199:1996/(R

42、)2002 Identical ISO 8637:2004 ANSI/AAMI RD16:2007 Major technical variations ISO 8638:2004 ANSI/AAMI RD17:2007 Major technical variations ISO 10993-1:2003 ANSI/AAMI/ISO 10993-1:2003 Identical ISO 10993-2:2006 ANSI/AAMI/ISO 10993-2:2006 Identical ISO 10993-3:2003 ANSI/AAMI/ISO 10993-3:2003 Identical

43、ISO 10993-4:2002 and Amendment 1:2006 ANSI/AAMI/ISO 10993-4:2002/(R)2009 and Amendment 1:2006/(R)2009 Identical ISO 10993-5:1999 ANSI/AAMI/ISO 10993-5:1999 Identical ISO 10993-6:2007 ANSI/AAMI/ISO 10993-6:2007 Identical ISO 10993-7:2008 ANSI/AAMI/ISO 10993-7:2008 Identical ISO 10993-9:1999 ANSI/AAMI

44、/ISO 10993-9:1999/(R)2005 Identical ISO 10993-10:2002 and Amendment 1:2006 ANSI/AAMI BE78:2002/(R)2008 ANSI/AAMI BE78:2002/A1:2006/(R)2008 Minor technical variations Identical ISO 10993-11:2006 ANSI/AAMI/ISO 10993-11:2006 Identical ISO 10993-12:2007 ANSI/AAMI/ISO 10993-12:2007 Identical ISO 10993-13

45、:1998 ANSI/AAMI/ISO 10993-13:1999/(R)2004 Identical ISO 10993-14:2001 ANSI/AAMI/ISO 10993-14:2001/(R)2006 Identical ISO 10993-15:2000 ANSI/AAMI/ISO 10993-15:2000/(R)2006 Identical ISO 10993-16:1997 ANSI/AAMI/ISO 10993-16:1997/(R)2009 Identical ISO 10993-17:2002 ANSI/AAMI/ISO 10993-17:2002/(R)2008 Id

46、entical ISO 10993-18:2005 ANSI/AAMI BE83:2006 Major technical variations ISO/TS 10993-19:2006 ANSI/AAMI/ISO TIR10993-19:2006 Identical ISO/TS 10993-20:2006 ANSI/AAMI/ISO TIR10993-20:2006 Identical ISO 11135-1:2007 ANSI/AAMI/ISO 11135-1:2007 Identical 2009 Association for the Advancement of Medical I

47、nstrumentation ANSI/AAMI/IEC TIR62296:2009 vii International designation U.S. designation Equivalency ISO/TS 11135-2:2008 ANSI/AAMI/ISO TIR11135-2:2008 Identical ISO 11137-1:2006ANSI/AAMI/ISO 11137-1:2006 Identical ISO 11137-2:2006 (2006-08-01 corrected version)ANSI/AAMI/ISO 11137-2:2006 Identical I

48、SO 11137-3:2006ANSI/AAMI/ISO 11137-3:2006 Identical ISO 11138-1: 2006 ANSI/AAMI/ISO 11138-1:2006 Identical ISO 11138-2: 2006 ANSI/AAMI/ISO 11138-2:2006 Identical ISO 11138-3: 2006 ANSI/AAMI/ISO 11138-3:2006 Identical ISO 11138-4: 2006 ANSI/AAMI/ISO 11138-4:2006 Identical ISO 11138-5: 2006 ANSI/AAMI/

49、ISO 11138-5:2006 Identical ISO/TS 11139:2006 ANSI/AAMI/ISO 11139:2006 Identical ISO 11140-1:2005 ANSI/AAMI/ISO 11140-1:2005 Identical ISO 11140-3:2007 ANSI/AAMI/ISO 11140-3:2007 Identical ISO 11140-4:2007 ANSI/AAMI/ISO 11140-4:2007 Identical ISO 11140-5:2007 ANSI/AAMI/ISO 11140-5:2007 Identical ISO 11607-1:2006ANSI/AAMI/ISO 11607-1:2006 Identical ISO 11607-2:2006ANSI/AAMI/ISO 11607-2:2006 Identical ISO 11737-1: 2006 ANSI/AAMI/ISO 11737-1:2006 Identical ISO 11737-2:1998 ANSI/AAMI/ISO 11737-2:1998 Identical ISO 13408-1:2008 ANSI/AAMI/ISO 13408-1:2008 Identical ISO 13408-2:20