"IEC60601-1:2020医疗器械电气安全标准综合版本"

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IEC60601-1是一项涉及医疗器械电气安全的国际标准。该标准的最新版本为IEC 60601-1 Edition 3.2，发布于2020年8月。该标准规定了医疗电气设备的基本安全要求和关键性能。 IEC 60601-1标准的目的是确保医疗设备在使用过程中的安全性和有效性。这一标准适用于各种医疗器械，如电子血压计、心电图仪、X射线设备等。它要求设备制造商在设计、制造和测试医疗器械时必须符合特定的安全标准，以保护医护人员、患者和用户的安全。 IEC 60601-1标准包含了许多关于设备设计和测试的详细要求。其中最重要的要求之一是防止电击和火灾的措施。该标准要求设备必须具备良好的绝缘性能、接地保护、漏电电流限制等，以防止电击事故的发生。此外，标准还要求设备必须通过各种测试，确保其在异常情况下的安全性能，如电压波动、电磁干扰等。除了基本的安全要求外，IEC 60601-1标准还规定了设备的关键性能。这些性能要求确保了设备的质量和有效性。例如，一个心电图仪必须能够准确地记录和分析心电图信号，而一个手术台必须具备良好的稳定性和可调节性，以适应不同的手术需求。 IEC 60601-1标准还包含了一些关于设备标签和用户手册的规定。设备的标签必须包含必要的警示和注意事项，以提醒用户使用设备时可能存在的风险。用户手册必须提供详细的操作说明和维护要求，使用户可以正确地使用和维护设备。 IEC 60601-1标准在国际上被广泛采用，并且被用作医疗电气设备的技术规范和法规依据。符合该标准的设备通常可以得到国际市场的认可和接受。因此，设备制造商通常必须确保他们的产品符合IEC 60601-1的要求，以满足不同国家的进口要求。总之，IEC 60601-1是一项涉及医疗器械电气安全的重要国际标准。该标准规定了医疗设备的基本安全要求和关键性能，旨在保护医护人员、患者和用户的安全。符合该标准的设备通常可以获得国际市场的认可和接受。设备制造商必须仔细遵守该标准的要求，并确保其产品符合国际规范和法规。

IEC 60601-1:2005+AMD1:2012 – 7 –

+AMD2:2020 CSV  IEC 2020

Figure A.10 – Floating circuit .............................................................................................. 271

Figure A.11 – Interruption of a power-carrying conductor between ME EQUIPMENT parts

in separate

ENCLOSURES ...................................................................................................... 272

Figure A.12 – Identification of MEANS OF PATIENT PROTECTION and MEANS OF OPERATOR

PROTECTION ...............................................................................................................................

Figure A.13 – Allowable protective earth impedance where the fault current is limited ........ 289

Figure A.14 – Probability of ventricular fibrillation ............................................................... 295

Figure A.15 – Example of a measuring circuit for the PATIENT LEAKAGE CURRENT from a

PATIENT CONNECTION to earth for ME EQUIPMENT with multiple PATIENT CONNECTIONS ............. 300

Figure A.16 – Instability test conditions ............................................................................... 313

Figure A.17 – Example of determining TENSILE SAFETY FACTOR using Table 21 .................... 319

Figure A.18 – Example of determining design and test loads .............................................. 320

Figure A.19 – Example of human body mass distribution .................................................... 320

Figure A.20 – Relationship of the terms used to describe equipment, ACCESSORIES or

equipment parts .................................................................................................................. 246

Figure A.21 – Example of ME EQUIPMENT having two different functions on one common

APPLIED PART circuit ............................................................................................................. 287

Figure A.22 – Maximum allowable temperature for surfaces and APPLIED PARTS at

higher altitudes ................................................................................................................... 325

Figure A.23 – Example of the needed MEANS OF OPERATOR PROTECTION between the

terminals of an

INTERNAL ELECTRICAL POWER SOURCE and a subsequent protective

device ................................................................................................................................. 343

Figure A.24 – Example of Scenario 1 .................................................................................. 276

Figure A.25 – Example of Scenario 2 .................................................................................. 277

Figure A.26 – Procedure for determination of AIR CLEARANCE requirements

IEC TR 62368-2:2019 [77], 5.4.2.1 (modified) ..................................................................... 281

Figure E.1 – TYPE B APPLIED PART ........................................................................................ 367

Figure E.2 – TYPE BF APPLIED PART ...................................................................................... 367

Figure E.3 – TYPE CF APPLIED PART ...................................................................................... 368

Figure E.4 – PATIENT AUXILIARY CURRENT ............................................................................. 368

Figure E.5 – Loading of the PATIENT CONNECTIONS if specified by the MANUFACTURER .......... 368

Figure F.1 – Measuring supply circuit with one side of the SUPPLY MAINS at

approximately earth potential .............................................................................................. 369

Figure F.2 – Measuring supply circuit with SUPPLY MAINS approximately symmetrical to

earth potential ..................................................................................................................... 369

Figure F.3 – Measuring supply circuit for polyphase ME EQUIPMENT specified for

connection to a polyphase

SUPPLY MAINS ............................................................................. 370

Figure F.4 – Measuring supply circuit for single-phase ME EQUIPMENT specified for

connection to a polyphase

SUPPLY MAINS ............................................................................. 370

Figure F.5 – Measuring supply circuit for ME EQUIPMENT having a separate power

supply unit or

intended to receive its power from another equipment in an ME SYSTEM ......... 371

Figure G.1– Maximum allowable current I

as a function of the maximum allowable

voltage U

measured in a purely resistive circuit with the most flammable mixture of

ether vapour with air ........................................................................................................... 378

Figure G.2 – Maximum allowable voltage U

as a function of the capacitance C

max

measured in a capacitive circuit with the most flammable mixture of ether vapour

with air ................................................................................................................................ 379

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– 8 – IEC 60601-1:2005+AMD1:2012

+AMD2:2020 CSV  IEC 2020

Figure G.3 – Maximum allowable current I

as a function of the inductance L

max

measured in an inductive circuit with the most flammable mixture of ether vapour with

air ....................................................................................................................................... 379

Figure G.4 – Maximum allowable current I

as a function of the maximum allowable

voltage U

measured in a purely resistive circuit with the most flammable mixture of

ether vapour with oxygen .................................................................................................... 383

Figure G.5 – Maximum allowable voltage U

as a function of the capacitance C

max

measured in a capacitive circuit with the most flammable mixture of ether vapour with

oxygen ................................................................................................................................ 384

Figure G.6 – Maximum allowable current I

as a function of the inductance L

max

measured in an inductive circuit with the most flammable mixture of ether vapour with

oxygen ................................................................................................................................ 385

Figure G.7 – Test apparatus ............................................................................................... 387

Figure H.1 – Examples of PEMS/ PESS structures ............................................................. 389

Figure H.2 – A PEMS DEVELOPMENT LIFE-CYCLE model .......................................................... 390

Figure H.3 – PEMS documentation requirements from Clause 14 and ISO 14971:2000

Not used ............................................................................................................................. 394

Figure H.4 – Example of potential parameters required to be specified for

NETWORK/DATA COUPLING an IT-NETWORK ............................................................................. 400

Figure I.1 – Example of the construction of a MULTIPLE SOCKET-OUTLET (MSO) ...................... 405

Figure I.2 – Examples of application of MULTIPLE SOCKET-OUTLETS (MSO) ............................. 406

Figure J.1 – Insulation example 1 ....................................................................................... 407

Figure J.2 – Insulation example 2 ....................................................................................... 407

Figure J.3 – Insulation example 3 ....................................................................................... 407

Figure J.4 – Insulation example 4 ....................................................................................... 408

Figure J.5 – Insulation example 5 ....................................................................................... 408

Figure J.6 – Insulation example 6 ....................................................................................... 409

Figure J.7 – Insulation example 7 ....................................................................................... 409

Figure K.1 – ME EQUIPMENT with an ENCLOSURE made of insulating material ........................ 410

Figure K.2 – ME EQUIPMENT with an F-TYPE APPLIED PART ..................................................... 410

Figure K.3 – ME EQUIPMENT with an APPLIED PART and a SIGNAL INPUT/OUTPUT PART ............. 411

Figure K.4 – ME EQUIPMENT with a PATIENT CONNECTION of a TYPE B APPLIED PART that is

not

PROTECTIVELY EARTHED .................................................................................................. 411

Figure K.5 – ME EQUIPMENT with a PATIENT CONNECTION of a TYPE BF APPLIED PART that

is not

PROTECTIVELY EARTHED .............................................................................................. 412

Table 1 – Units outside the SI units system that may be used on ME EQUIPMENT ................... 69

Table 2 – Colours of indicator lights and their meanings of indicator lights and alarm

indicator lights for ME EQUIPMENT ........................................................................................... 72

Table 3 – * Allowable values of PATIENT LEAKAGE CURRENTS and PATIENT AUXILIARY

CURRENTS

under NORMAL CONDITION and SINGLE FAULT CONDITION ......................................... 103

Table 4 – * Allowable values of PATIENT LEAKAGE CURRENTS under the special test

conditions identified in 8.7.4.7 ............................................................................................ 104

Table 5 – Legends of symbols for Figure 9 to Figure 11, Figure 13 to Figure 20, Figure

A.15, Annexes E and F ....................................................................................................... 118

Table 6 – Test voltages for solid insulation forming a MEANS OF PROTECTION ....................... 126

Table 7 – Test voltages for MEANS OF OPERATOR PROTECTION ............................................... 127

Table 8 – Multiplication factors for AIR CLEARANCES for altitudes up to 5 000 m .................... 130

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IEC 60601-1:2005+AMD1:2012 – 9 –

+AMD2:2020 CSV  IEC 2020

Table 9 – Material group classification ................................................................................ 131

Table 10 – MAINS TRANSIENT VOLTAGE .................................................................................. 132

Table 11 – Minimum CREEPAGE DISTANCES and AIR CLEARANCES between parts of

opposite polarity of the MAINS PART Not used ....................................................................... 133

Table 12 – Minimum CREEPAGE DISTANCES and AIR CLEARANCES providing MEANS OF

PATIENT PROTECTION

............................................................................................................ 134

Table 13 – Minimum AIR CLEARANCES providing MEANS OF OPERATOR PROTECTION from

the

MAINS PART .................................................................................................................... 135

Table 14 – Additional AIR CLEARANCES for insulation in MAINS PARTS with PEAK WORKING

VOLTAGES

exceeding the peak value of the NOMINAL MAINS VOLTAGE

.................................. 136

Table 15 – Minimum AIR CLEARANCES for MEANS OF OPERATOR PROTECTION in SECONDARY

CIRCUITS

.............................................................................................................................. 137

Table 16 – Minimum CREEPAGE DISTANCES providing MEANS OF OPERATOR PROTECTION

...... 138

Table 17 – NOMINAL cross-sectional area of conductors of a POWER SUPPLY CORD ............... 151

Table 18 – Testing of cord anchorages ............................................................................... 152

Table 19 – MECHANICAL HAZARDS covered by this clause ..................................................... 155

Table 20 – Acceptable gaps

.............................................................................................. 157

Table 21 – Determination of TENSILE SAFETY FACTOR ........................................................... 172

Table 22 – Allowable maximum temperatures of parts......................................................... 180

Table 23 – Allowable maximum temperatures for ME EQUIPMENT parts ACCESSIBLE PARTS

that are likely to be touched ................................................................................................ 180

Table 24 – Allowable maximum temperatures for skin contact with ME EQUIPMENT

APPLIED PARTS ..................................................................................................................... 181

Table 25 – Acceptable perforation of the bottom of an ENCLOSURE ...................................... 190

Table 26 – * Temperature limits of motor windings .............................................................. 200

Table 27 – Maximum motor winding steady-state temperature ............................................ 202

Table 28 – Mechanical strength test applicability ................................................................ 209

Table 29 – Drop height ....................................................................................................... 211

Table 30 – Test torques for rotating controls ....................................................................... 216

Table 31 – Maximum allowable temperatures of transformer windings under overload

and short-circuit conditions at 25 °C (± 5 °C) ambient temperature ..................................... 219

Table 32 – Test current for transformers ............................................................................. 220

Table 33 – Test conditions for overtravel end stop test ....................................................... 160

Table 34 – Allowable maximum temperatures for ACCESSIBLE PARTS that are likely to be

touched, but not intended to be touched to operate the

ME EQUIPMENT ................................ 197

Table A.1 – Values of AIR CLEARANCE and CREEPAGE DISTANCE derived from Table 7 of

IEC 61010-1:2001 and Table 12 ......................................................................................... 304

Table A.2 – CREEPAGE DISTANCES to avoid failure due to tracking from IEC 60664-1 ........... 305

Table A.3 – Instability test conditions .................................................................................. 312

Table A.4 – Allowable time exposure for level of acceleration ............................................. 315

Table A.5 – Guidance on surface temperatures for ME EQUIPMENT that creates low

temperatures (cools) for therapeutic purposes or as part of its operation ............................ 324

Table A.6 – Typical scenarios for the use of equipment complying with IEC 62368-

1:2018 in

ME EQUIPMENT ...................................................................................................... 276

Table C.1– Marking on the outside of ME EQUIPMENT, ME SYSTEMS or their parts

................. 355

Table C.2 – Marking on the inside of ME EQUIPMENT, ME SYSTEMS or their parts ................... 356

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IEC 60601-1:2005+AMD1:2012 – 11 –

+AMD2:2020 CSV  IEC 2020

INTERNATIONAL ELECTROTECHNICAL COMMISSION

____________

MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety

and essential performance

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 promote

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 Guides (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 also 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 possible, 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. While 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 undertake 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 provides no marking procedure to indicate its approval and cannot be rendered responsible for any

equipment declared to be in conformity with an IEC Publication.

6) All users should ensure that they have the latest edition of 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 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) Attention is drawn to the possibility that some of the elements of this IEC Publication may be the subject of

patent rights. IEC shall not be held responsible for identifying any or all such patent rights.

This consolidated version of the official IEC Standard and its amendments has been

prepared for user convenience.

IEC 60601-1 edition 3.2 contains the third edition (2005-12) [documents 62A/505A/FDIS

and 62A/512/RVD], its amendment 1 (2012-07) [documents 62A/805/FDIS and

62A/820/RVD] and its amendment 2 (2020-08) [documents 62A/1389/FDIS and

62A/1404/RVD].

This Consolidated version includes the contents of the corrigenda 1 (2006-12) and 2

(2007-12), the contents of the corrigendum to Amendment 1 (2014-07), as well as the

interpretation sheets 1 (2008-04), 2 (2009-01) and 3 (2013-05).

In this Redline version, a vertical line in the margin shows where the technical content

is modified by amendments 1 and 2. Additions are in green text, deletions are in

strikethrough red text. A separate Final version with all changes accepted is available

in this publication.

Provided by IHS Markit under license with IEC

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No reproduction or networking permitted without license from IHS

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