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    IEC TR 62348-2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1 2005 and mapping of the clauses of the IEC 60601-1 2005.pdf

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    IEC TR 62348-2012 Assessment of the impact of the most significant changes in Amendment 1 to IEC 60601-1 2005 and mapping of the clauses of the IEC 60601-1 2005.pdf

    1、 IEC/TR 62348 Edition 2.0 2012-12 TECHNICAL REPORT 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 IEC/TR 62348:2012(E) colour inside THIS PUBLICATION IS COPYRIGHT PROTECTED Copyright 2

    2、012 IEC, Geneva, Switzerland All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying and microfilm, without permission in writing from either IEC or IECs member National C

    3、ommittee in the country of the requester. If you have any questions about IEC copyright or have an enquiry about obtaining additional rights to this publication, please contact the address below or your local IEC member National Committee for further information. IEC Central Office Tel.: +41 22 919

    4、02 11 3, rue de Varemb Fax: +41 22 919 03 00 CH-1211 Geneva 20 infoiec.ch Switzerland www.iec.ch About the IEC The International Electrotechnical Commission (IEC) is the leading global organization that prepares and publishes International Standards for all electrical, electronic and related technol

    5、ogies. About IEC publications The technical content of IEC publications is kept under constant review by the IEC. Please make sure that you have the latest edition, a corrigenda or an amendment might have been published. Useful links: IEC publications search - www.iec.ch/searchpub The advanced searc

    6、h enables you to find IEC publications by a variety of criteria (reference number, text, technical committee,). It also gives information on projects, replaced and withdrawn publications. IEC Just Published - webstore.iec.ch/justpublished Stay up to date on all new IEC publications. Just Published d

    7、etails all new publications released. Available on-line and also once a month by email. Electropedia - www.electropedia.org The worlds leading online dictionary of electronic and electrical terms containing more than 30 000 terms and definitions in English and French, with equivalent terms in additi

    8、onal languages. Also known as the International Electrotechnical Vocabulary (IEV) on-line. Customer Service Centre - webstore.iec.ch/csc If you wish to give us your feedback on this publication or need further assistance, please contact the Customer Service Centre: csciec.ch. IEC/TR 62348 Edition 2.

    9、0 2012-12 TECHNICAL REPORT 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 INTERNATIONAL ELECTROTECHNICAL COMMISSION XD ICS 11.040 PRICE CODE ISBN 978-2-83220-548-8 Registered trademark

    10、 of the International Electrotechnical Commission Warning! Make sure that you obtained this publication from an authorized distributor. colour inside 2 TR 62348 IEC:2012(E) CONTENTS FOREWORD . 6 INTRODUCTION . 8 1 Scope . 9 2 Normative references . 9 3 Terms and definitions . 9 4 Assessment of the c

    11、hanges in Amendment 1:2012 . 9 5 Changes impacting many users of the standard 13 5.1 Updated normative references (Clause 2) Moderate impact . 13 5.2 Definition and rationale for EXPECTED SERVICE LIFE (Definition 3.28 and rationale for 4.4) Moderate impact . 13 5.3 Restructuring of RISK MANAGEMENT (

    12、Subclause 4.2) Significant impact . 13 5.4 Application of ESSENTIAL PERFORMANCE (Subclause 4.3) Significant impact 13 5.5 Revision to the concept of equivalent safety (Subclause 4.5) Significant impact 14 5.6 Requirements for parts that contact the PATIENT (Subclause 4.6) Significant impact 14 5.7 S

    13、teady-state measurement of input of the ME EQUIPMENT or ME SYSTEM (Subclause 4.11) Moderate impact 14 5.8 Simultaneous fault testing (Subclause 5.1) Moderate impact . 14 5.9 SUPPLY MAINS test characteristics (Subclause 5.5 a) Significant impact 15 5.10 Humidity preconditioning (Subclause 5.7) Signif

    14、icant impact . 15 5.11 Actuating mechanisms (Subclause 5.9.2.3) Moderate impact 15 5.12 Legibility of markings (Subclause 7.1.2) Moderate impact . 15 5.13 Identification of ME EQUIPMENT, parts and ACCESSORIES (Subclauses 7.2.1 and 7.2.4) Significant impact . 15 5.14 Marking of fuses, THERMAL CUT-OUT

    15、S and OVER-CURRENT RELEASES (Subclause 7.3.4) Moderate impact . 15 5.15 Marking of stand-by control (Subclause 7.4.2) Moderate impact 15 5.16 Use of safety signs (Subclause 7.5) Moderate impact 16 5.17 General requirements for ACCOMPANYING DOCUMENTS (Subclause 7.9.1) Significant impact 16 5.18 Dispo

    16、sal of waste (Subclause 7.9.2.15) Moderate impact 16 5.19 Unique version identification (Subclauses 7.9.2.19 and 7.9.3.1) Moderate impact 16 5.20 Disclosure of ESSENTIAL PERFORMANCE (Subclause 7.9.3.1) Significant impact 16 5.21 Change to the fundamental rule of protection against electric shock (Su

    17、bclause 8.1 b) Moderate impact 16 5.22 Use of Y capacitors as a MEANS OF PROTECTION (Subclauses 8.5.1.2 and 8.5.1.3) Moderate impact . 16 5.23 Requirements for impedance and current-carrying capabilities (Subclause 8.6.4) Moderate impact 17 5.24 Allowable values of LEAKAGE CURRENTS that can flow in

    18、a FUNCTIONAL EARTH CONDUCTOR (Subclause 8.7.3) Substantial impact 17 5.25 Measurement of the EARTH LEAKAGE CURRENT and current in functional earth connection (Subclause 8.7.4.5) Moderate impact 17 5.26 Clarification of the insulation to be tested (Subclause 8.8.1) Significant impact 17 TR 62348 IEC:

    19、2012(E) 3 5.27 Spacing for one MEANS OF OPERATOR PROTECTION for a WORKING VOLTAGE of 25 V r.m.s. (Table 16) Moderate impact . 17 5.28 Measurement of CREEPAGE DISTANCES AND AIR CLEARANCES (Subclause 8.9.4) Moderate impact 17 5.29 Spillage on ME EQUIPMENT and ME SYSTEMS (Subclause 11.6.3) Moderate imp

    20、act 17 5.30 Cleaning and disinfection of ME EQUIPMENT and ME SYSTEMS (Subclause 11.6.6) Moderate impact 18 5.31 Interruption of the power supply / SUPPLY MAINS to ME EQUIPMENT or ME SYSTEM (Subclauses 11.8 and 16.8) Significant impact . 18 5.32 Emissions, deformation of ENCLOSURE or exceeding maximu

    21、m temperature (Subclause 13.1.2) Significant impact 18 5.33 PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS) (Subclause 14.1) Moderate impact 18 5.34 Design and implementation (Subclause 14.9) Moderate impact . 18 5.35 PEMS VALIDATION (Subclause 14.11) Moderate impact 18 5.36 Mechanical strength (Subc

    22、lause 15.3.1) Moderate impact . 18 5.37 Actuating parts of controls of ME EQUIPMENT (Subclause 15.4.6.1 b) Moderate impact 19 5.38 Limitation of movement (Subclause 15.4.6.2) Moderate impact . 19 5.39 Transformers (Subclause 15.5.1.1) Moderate impact . 19 5.40 Overload test (Subclause 15.5.1.3) Mode

    23、rate impact . 19 5.41 Dielectric strength (Subclause 15.5.2) Moderate impact 19 5.42 Construction of transformers used to provide separation as required by 8.5 (Subclause 15.5.3) Significant impact 19 5.43 Resistors bridging a MEANS OF PROTECTION (Rationale for Subclause 4.8) Moderate impact 19 6 Ch

    24、anges impacting particular users of the standard 20 6.1 ME EQUIPMENT intended to receive power from other equipment (Subclause 7.2.5) Significant impact 20 6.2 ME EQUIPMENT or ACCESSORIES supplied sterile (Subclauses 7.2.17 and 7.9.2.18) Moderate impact . 20 6.3 ME EQUIPMENT supplied from an externa

    25、l pressure source (Subclause 7.2.18) Moderate impact 20 6.4 Mass of MOBILE ME EQUIPMENT (Subclause 7.2.21) Significant impact . 20 6.5 General requirements for the instructions for use when the PATIENT is an OPERATOR (Subclause 7.9.2.1) Moderate impact 20 6.6 ME EQUIPMENT emitting radiation (Subclau

    26、se 7.9.2.17) Moderate impact 20 6.7 ME EQUIPMENT with DEFIBRILLATION-PROOF APPLIED PARTS (Subclause 8.5.5.1 a) Significant impact . 21 6.8 Energy reduction test for ME EQUIPMENT with DEFIBRILLATION-PROOF APPLIED PARTS (Subclause 8.5.5.2) Significant impact 21 6.9 Measurement of LEAKAGE CURRENT for s

    27、terile equipment (Subclause 8.7.1 b) Moderate impact 21 6.10 Isolation of PERMANENTLY INSTALLED ME EQUIPMENT from the SUPPLY MAINS (Subclause 8.11.1) Moderate impact . 21 6.11 Protective measures (Subclause 9.2.2.4.4) Moderate impact . 21 6.12 Continuous activation (Subclause 9.2.2.5) Moderate impac

    28、t 22 6.13 Speed of movement(s) (Subclause 9.2.2.6) Moderate impact 22 6.14 Unintended movement (Subclause 9.2.3.1) Significant impact . 22 6.15 Overtravel end stops (subclause 9.2.3.2) Moderate impact 22 6.16 Overbalancing from horizontal and vertical forces (Subclause 9.4.2.3 a) Significant impact

    29、22 4 TR 62348 IEC:2012(E) 6.17 Movement over a threshold (Subclause 9.4.2.4.3) Significant impact . 22 6.18 Instability of MOBILE ME EQUIPMENT in transport position (Subclause 9.4.3.1 c) Moderate impact . 22 6.19 Instability of MOBILE ME EQUIPMENT on an incline surface and in other than transport po

    30、sition (Subclause 9.4.3.2 a) Moderate impact 22 6.20 Instability of MOBILE ME EQUIPMENT from lateral forces in other than transport position (Subclause 9.4.3.2 b) Significant impact . 22 6.21 Acoustic energy and vibration (Subclause 9.6.1) Moderate impact 22 6.22 Audible acoustic energy measurements

    31、 (Subclause 9.6.2.1) Moderate impact 23 6.23 Static forces due to loading from persons (Subclause 9.8.3.2) Moderate impact 23 6.24 Dynamic forces due to loading from persons (Subclause 9.8.3.3) Moderate impact 23 6.25 ME EQUIPMENT not intended to produce diagnostic or therapeutic X-radiation (Subcla

    32、use 10.1.1) Moderate impact . 23 6.26 ME EQUIPMENT intended to produce diagnostic or therapeutic X-radiation (Subclause 10.1.2) Moderate impact . 23 6.27 Microwave radiation (Subclause 10.3) Significant impact . 23 6.28 Lasers and light-emitting diodes (LEDs) (Subclause 10.4) Moderate impact 23 6.29

    33、 APPLIED PARTS not intended to supply heat to a PATIENT (Subclause 11.1.2.2) Moderate impact 23 6.30 Overflow in ME EQUIPMENT (Subclause 11.6.2) Moderate impact 24 6.31 Diagnostic X-ray equipment (Subclause 12.4.5.2) Moderate impact . 24 6.32 PEMS intended to be incorporated into an IT-NETWORK (Subc

    34、lause 14.13) Moderate impact 24 6.33 Rough handling test (Subclause 15.3.5) Moderate impact . 24 6.34 Application of temperature and overload control devices (Subclause 15.4.2.1 d) Moderate impact . 24 6.35 Excessive current and voltage protection (Subclause 15.4.3.5) Moderate impact 24 6.36 Entry o

    35、f liquids for foot-operated control devices (Subclause 15.4.7.3) Moderate impact 24 6.37 ME SYSTEM power supply (Subclause 16.3) Moderate impact . 24 6.38 General measurement conditions for ME SYSTEMS (Subclause 16.6.4.1) Moderate impact 25 6.39 An MSO combined with a separating transformer (Subclau

    36、se 16.9.2.1 d) Moderate impact 25 6.40 Impedance of protective earth connections in ME SYSTEMS (Subclause 16.9.2.2) Moderate impact . 25 7 Mapping . 25 7.1 Mapping to the second edition of IEC 60601-1. 25 7.2 Mapping to the second edition of IEC 60601-1-1 . 59 7.3 Mapping to the first edition of IEC

    37、 60601-1-4, as amended 61 7.4 Mapping from IEC 60601-1:2005 + A1:2012 64 Bibliography 101 Table 1 Amendment 1 changes assessed as having the potential for a significant impact . 10 Table 2 Amendment 1 changes assessed as having the potential for a moderate impact (1 of 2) 11 TR 62348 IEC:2012(E) 5 T

    38、able 3 Mapping between the elements of the second edition of IEC 60601-1 as amended and IEC 60601-1:2005 (1 of 35) . 25 Table 4 Mapping between the elements of the second edition of IEC 60601-1-1 and IEC 60601-1:2005 (1 of 2) . 60 Table 5 Mapping between the elements of the first edition of IEC 6060

    39、1-1-4 as amended and IEC 60601-1:2005 (1 of 3). 62 Table 6 Mapping between the elements of IEC 60601-1:2005 + A1:2012 and other standards (1 of 36) . 65 6 TR 62348 IEC:2012(E) INTERNATIONAL ELECTROTECHNICAL COMMISSION _ ASSESSMENT OF THE IMPACT OF THE MOST SIGNIFICANT CHANGES IN AMENDMENT 1 TO IEC 6

    40、0601-1:2005 AND MAPPING OF THE CLAUSES OF IEC 60601-1:2005 TO THE PREVIOUS EDITION FOREWORD 1) The International Electrotechnical Commission (IEC) is a worldwide organization for standardization comprising all national electrotechnical committees (IEC National Committees). The object of IEC is to pr

    41、omote international co-operation on all questions concerning standardization in the electrical and electronic fields. To this end and in addition to other activities, IEC publishes International Standards, Technical Specifications, Technical Reports, Publicly Available Specifications (PAS) and Guide

    42、s (hereafter referred to as “IEC Publication(s)”). Their preparation is entrusted to technical committees; any IEC National Committee interested in the subject dealt with may participate in this preparatory work. International, governmental and non- governmental organizations liaising with the IEC a

    43、lso participate in this preparation. IEC collaborates closely with the International Organization for Standardization (ISO) in accordance with conditions determined by agreement between the two organizations. 2) The formal decisions or agreements of IEC on technical matters express, as nearly as pos

    44、sible, an international consensus of opinion on the relevant subjects since each technical committee has representation from all interested IEC National Committees. 3) IEC Publications have the form of recommendations for international use and are accepted by IEC National Committees in that sense. W

    45、hile all reasonable efforts are made to ensure that the technical content of IEC Publications is accurate, IEC cannot be held responsible for the way in which they are used or for any misinterpretation by any end user. 4) In order to promote international uniformity, IEC National Committees undertak

    46、e to apply IEC Publications transparently to the maximum extent possible in their national and regional publications. Any divergence between any IEC Publication and the corresponding national or regional publication shall be clearly indicated in the latter. 5) IEC itself does not provide any attesta

    47、tion of conformity. Independent certification bodies provide conformity assessment services and, in some areas, access to IEC marks of conformity. IEC is not responsible for any services carried out by independent certification bodies. 6) All users should ensure that they have the latest edition of

    48、this publication. 7) No liability shall attach to IEC or its directors, employees, servants or agents including individual experts and members of its technical committees and IEC National Committees for any personal injury, property damage or other damage of any nature whatsoever, whether direct or

    49、indirect, or for costs (including legal fees) and expenses arising out of the publication, use of, or reliance upon, this IEC Publication or any other IEC Publications. 8) Attention is drawn to the Normative references cited in this publication. Use of the referenced publications is indispensable for the correct application of this publication. 9) Attenti


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