ANSI TIR62348-2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1 2005 and mapping of the clauses of IEC 60601-1 2005 to the previous editio.pdf

1、ANSI/AAMI/ IEC TIR 62348:2012Technical Information ReportAssessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous editionAn ANSI Technical Report prepared by AAMI ANSI/AAMI/IEC TIR62348:2012 (Revision o

2、f ANSI/AAMI/IEC TIR62348:2006) Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1:2005 and mapping of the clauses of IEC 60601-1:2005 to the previous edition Approved 31 December 2012 by Association for the Advancement of Medical Instrumentation Approved 23 Decemb

3、er 2012 by American National Standards Institute, Inc. Abstract: The second edition of this technical report was prepared by the Secretariat of IEC/SC 62A to summarize those changes cited in Amendment 1 that were assessed during the development process as having a moderate to significant impact on u

4、sers of IEC 60601-1. The tables from the first edition of this technical report were retained in the second edition because there are counties that have not fully transitioned to the third edition of IEC 60601-1. Therefore, the original contents of IEC/TR 62348 remain useful in those countries. Keyw

5、ords: medical electrical equipment, medical electrical systems, safety, essential performance Published by Association for the Advancement of Medical Instrumentation 4301 N. Fairfax Drive, Suite 301 Arlington, VA 22203-1633 www.aami.org 2013 by the Association for the Advancement of Medical Instrume

6、ntation All Rights Reserved This publication is subject to copyright claims of ISO, 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 pertaining to this docume

7、nt 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 Instrumentation. Violators risk legal

8、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, complete the reprint request form at www.aami.org or contact AAMI, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. Phone: +1-703-525-

9、4890; Fax: +1-703-525-1067. Printed in the United States of America ISBN 1570204756 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 m

10、edical technology. Although the material presented in a TIR may 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 underst

11、and the differences between these 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,

12、by the American National Standards 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 revie

13、wed, a standard must be acted onreaffirmed, 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 whethe

14、r the document is still usefulthat 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 recommend

15、ed practice, or because achieving 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 technolo

16、gy, readers are cautioned to ensure that they have also considered information that may 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 with

17、in the discretion and professional 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 th

18、is technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. ANSI Technical Report This AAMI TIR has been registered by the American National Standards Institute as an ANSI Technical Report. Publicatio

19、n of this ANSI Technical Report has 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

20、 and the material contained herein is not normative in nature. Comments on this technical information report are invited and should be sent to AAMI, Attn: Standards Department, 4301 N. Fairfax Drive, Suite 301, Arlington, VA 22203-1633. CONTENTS Glossary of equivalent standards vi Committee represen

21、tation . ix Background of AAMI adoption of IEC/TR 62348:2012 . x FOREWORD xiv INTRODUCTION xvi 1 Scope . 1 2 Normative references 1 3 Terms and definitions 1 4 Assessment of the changes in Amendment 1:2012 1 5 Changes impacting many users of the standard 5 5.1 Updated normative references (Clause 2)

22、 Moderate impact . 5 5.2 Definition and rationale for EXPECTED SERVICE LIFE (Definition 3.28 and rationale for 4.4) Moderate impact 5 5.3 Restructuring of RISK MANAGEMENT (Subclause 4.2) Significant impact . 5 5.4 Application of ESSENTIAL PERFORMANCE (Subclause 4.3) Significant impact . 5 5.5 Revisi

23、on to the concept of equivalent safety (Subclause 4.5) Significant impact . 6 5.6 Requirements for parts that contact the PATIENT (Subclause 4.6) Significant impact . 6 5.7 Steady-state measurement of input of the ME EQUIPMENT or ME SYSTEM (Subclause 4.11) Moderate impact . 6 5.8 Simultaneous fault

24、testing (Subclause 5.1) Moderate impact 6 5.9 SUPPLY MAINS test characteristics (Subclause 5.5 a) Significant impact . 7 5.10 Humidity preconditioning (Subclause 5.7) Significant impact 7 5.11 Actuating mechanisms (Subclause 5.9.2.3) Moderate impact . 7 5.12 Legibility of markings (Subclause 7.1.2)

25、Moderate impact 7 5.13 Identification of ME EQUIPMENT, parts and ACCESSORIES (Subclauses 7.2.1 and 7.2.4) Significant impact . 7 5.14 Marking of fuses, THERMAL CUT-OUTS and OVER-CURRENT RELEASES (Subclause 7.3.4) Moderate impact 7 5.15 Marking of stand-by control (Subclause 7.4.2) Moderate impact .

26、8 5.16 Use of safety signs (Subclause 7.5) Moderate impact 8 5.17 General requirements for ACCOMPANYING DOCUMENTS (Subclause 7.9.1) Significant impact. 8 5.18 Disposal of waste (Subclause 7.9.2.15) Moderate impact . 8 5.19 Unique version identification (Subclauses 7.9.2.19 and 7.9.3.1) Moderate impa

27、ct . 8 5.20 Disclosure of ESSENTIAL PERFORMANCE (Subclause 7.9.3.1) Significant impact 8 5.21 Change to the fundamental rule of protection against electric shock (Subclause 8.1 b) Moderate impact . 8 5.22 Use of Y capacitors as a MEANS OF PROTECTION (Subclauses 8.5.1.2 and 8.5.1.3) Moderate impact 9

28、 5.23 Requirements for impedance and current-carrying capabilities (Subclause 8.6.4) Moderate impact 9 5.24 Allowable values of LEAKAGE CURRENTS that can flow in a FUNCTIONAL EARTH CONDUCTOR (Subclause 8.7.3) Substantial impact 9 5.25 Measurement of the EARTH LEAKAGE CURRENT and current in functiona

29、l earth connection (Subclause 8.7.4.5) Moderate impact . 9 5.26 Clarification of the insulation to be tested (Subclause 8.8.1) Significant impact 9 5.27 Spacing for one MEANS OF OPERATOR PROTECTION for a WORKING VOLTAGE of 25 V r.m.s. (Table 16) Moderate impact . 9 5.28 Measurement of CREEPAGE DISTA

30、NCES AND AIR CLEARANCES (Subclause 8.9.4) Moderate impact 10 5.29 Spillage on ME EQUIPMENT and ME SYSTEMS (Subclause 11.6.3) Moderate impact . 10 5.30 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS (Subclause 11.6.6) Moderate impact 10 5.31 Interruption of the power supply / SUPPLY MAINS t

31、o ME EQUIPMENT or ME SYSTEM (Subclauses 11.8 and 16.8) Significant impact . 10 5.32 Emissions, deformation of ENCLOSURE or exceeding maximum temperature (Subclause 13.1.2) Significant impact 10 5.33 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) (Subclause 14.1) Moderate impact 10 5.34 Design and im

32、plementation (Subclause 14.9) Moderate impact 11 5.35 PEMS VALIDATION (Subclause 14.11) Moderate impact 11 5.36 Mechanical strength (Subclause 15.3.1) Moderate impact 11 5.37 Actuating parts of controls of ME EQUIPMENT (Subclause 15.4.6.1 b) Moderate impact . 11 5.38 Limitation of movement (Subclaus

33、e 15.4.6.2) Moderate impact 11 5.39 Transformers (Subclause 15.5.1.1) Moderate impact . 11 5.40 Overload test (Subclause 15.5.1.3) Moderate impact . 11 5.41 Dielectric strength (Subclause 15.5.2) Moderate impact . 12 5.42 Construction of transformers used to provide separation as required by 8.5 (Su

34、bclause 15.5.3) Significant impact 12 5.43 Resistors bridging a MEANS OF PROTECTION (Rationale for Subclause 4.8) Moderate impact 12 6 Changes impacting particular users of the standard 12 6.1 ME EQUIPMENT intended to receive power from other equipment (Subclause 7.2.5) Significant impact . 12 6.2 M

35、E EQUIPMENT or ACCESSORIES supplied sterile (Subclauses 7.2.17 and 7.9.2.18) Moderate impact . 12 6.3 ME EQUIPMENT supplied from an external pressure source (Subclause 7.2.18) Moderate impact 13 6.4 Mass of MOBILE ME EQUIPMENT (Subclause 7.2.21) Significant impact . 13 6.5 General requirements for t

36、he instructions for use when the PATIENT is an OPERATOR (Subclause 7.9.2.1) Moderate impact 13 6.6 ME EQUIPMENT emitting radiation (Subclause 7.9.2.17) Moderate impact. 13 6.7 ME EQUIPMENT with DEFIBRILLATION-PROOF APPLIED PARTS (Subclause 8.5.5.1 a) Significant impact. 13 6.8 Energy reduction test

37、for ME EQUIPMENT with DEFIBRILLATION-PROOF APPLIED PARTS (Subclause 8.5.5.2) Significant impact . 14 6.9 Measurement of LEAKAGE CURRENT for sterile equipment (Subclause 8.7.1 b) Moderate impact 14 6.10 Isolation of PERMANENTLY INSTALLED ME EQUIPMENT from the SUPPLY MAINS (Subclause 8.11.1) Moderate

38、impact 14 6.11 Protective measures (Subclause 9.2.2.4.4) Moderate impact . 14 6.12 Continuous activation (Subclause 9.2.2.5) Moderate impact . 14 6.13 Speed of movement(s) (Subclause 9.2.2.6) Moderate impact . 14 6.14 Unintended movement (Subclause 9.2.3.1) Significant impact 14 6.15 Overtravel end

39、stops (subclause 9.2.3.2) Moderate impact 14 6.16 Overbalancing from horizontal and vertical forces (Subclause 9.4.2.3 a) Significant impact. 15 6.17 Movement over a threshold (Subclause 9.4.2.4.3) Significant impact . 15 6.18 Instability of MOBILE ME EQUIPMENT in transport position (Subclause 9.4.3

40、.1 c) Moderate impact 15 6.19 Instability of MOBILE ME EQUIPMENT on an incline surface and in other than transport position (Subclause 9.4.3.2 a) Moderate impact . 15 6.20 Instability of MOBILE ME EQUIPMENT from lateral forces in other than transport position (Subclause 9.4.3.2 b) Significant impact

41、 15 6.21 Acoustic energy and vibration (Subclause 9.6.1) Moderate impact . 15 6.22 Audible acoustic energy measurements (Subclause 9.6.2.1) Moderate impact . 15 6.23 Static forces due to loading from persons (Subclause 9.8.3.2) Moderate impact 15 6.24 Dynamic forces due to loading from persons (Subc

42、lause 9.8.3.3) Moderate impact . 16 6.25 ME EQUIPMENT not intended to produce diagnostic or therapeutic X-radiation (Subclause 10.1.1) Moderate impact 16 6.26 ME EQUIPMENT intended to produce diagnostic or therapeutic X-radiation (Subclause 10.1.2) Moderate impact 16 6.27 Microwave radiation (Subcla

43、use 10.3) Significant impact . 16 6.28 Lasers and light-emitting diodes (LEDs) (Subclause 10.4) Moderate impact . 16 6.29 APPLIED PARTS not intended to supply heat to a PATIENT (Subclause 11.1.2.2) Moderate impact 16 6.30 Overflow in ME EQUIPMENT (Subclause 11.6.2) Moderate impact . 16 6.31 Diagnost

44、ic X-ray equipment (Subclause 12.4.5.2) Moderate impact . 16 6.32 PEMS intended to be incorporated into an IT-NETWORK (Subclause 14.13) Moderate impact 17 6.33 Rough handling test (Subclause 15.3.5) Moderate impact 17 6.34 Application of temperature and overload control devices (Subclause 15.4.2.1 d

45、) Moderate impact 17 6.35 Excessive current and voltage protection (Subclause 15.4.3.5) Moderate impact . 17 6.36 Entry of liquids for foot-operated control devices (Subclause 15.4.7.3) Moderate impact 17 6.37 ME SYSTEM power supply (Subclause 16.3) Moderate impact . 17 6.38 General measurement cond

46、itions for ME SYSTEMS (Subclause 16.6.4.1) Moderate impact 17 6.39 An MSO combined with a separating transformer (Subclause 16.9.2.1 d) Moderate impact 18 6.40 Impedance of protective earth connections in ME SYSTEMS (Subclause 16.9.2.2) Moderate impact 18 7 Mapping 18 7.1 Mapping to the second editi

47、on of IEC 60601-1 . 18 7.2 Mapping to the second edition of IEC 60601-1-1 52 7.3 Mapping to the first edition of IEC 60601-1-4, as amended 54 7.4 Mapping from IEC 60601-1:2005 + A1:2012 . 58 Bibliography 94 Table 1 Amendment 1 changes assessed as having the potential for a significant impact . 2 Tab

48、le 2 Amendment 1 changes assessed as having the potential for a moderate impact (1 of 2) 3 Table 3 Mapping between the elements of the second edition of IEC 60601-1 as amended and IEC 60601-1:2005 (1 of 35) . 18 Table 4 Mapping between the elements of the second edition of IEC 60601-1-1 and IEC 6060

49、1-1:2005 (1 of 2) . 53 Table 5 Mapping between the elements of the first edition of IEC 60601-1-4 as amended and IEC 60601-1:2005 (1 of 3) 55 Table 6 Mapping between the elements of IEC 60601-1:2005 + A1:2012 and other standards (1 of 36) 58 viii 2013 Association for the Advancement of Medical Instrumentation ANSI/AAMI/IEC TIR62348:2012 Glossary of equivalent standards International Standards a