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
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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
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