IEC 60601-1:2012版3.1：医用电器设备安全通用要求

2012

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IEC 60601-1是国际电工委员会(IEC)制定的一项关于医用电气设备安全要求的国际标准。该标准的最新版本是IEC 60601-1-2012，也被称为版本3.1。 IEC 60601-1标准的主要目的是确保医用电气设备在正常使用和预期使用条件下的安全性，并提供必要的性能。该标准适用于各种医疗设备，包括诊断设备、治疗设备、监护设备、手术设备等。它也适用于与医用设备相关的配件和系统。 IEC 60601-1标准对医用电气设备的基本安全性和基本性能提出了一些要求。其中，基本安全性要求包括对电气构造、电磁兼容性、机械安全性、防护等方面的要求。基本性能要求则包括对设备测量准确度、可靠性、工作条件等方面的要求。该标准的最新修订版IEC 60601-1-2012版本3.1对之前的标准进行了一些改进和更新。修订版对于电气构造、电磁兼容性、机械安全性等方面的要求进行了更新，并引入了一些新的要求以适应新的技术和市场需求。举例来说，该修订版强调了对于电隔离和防护措施的要求，并引入了新的安全测试方法。它还对设备的安全性能进行了更严格的要求，例如对于电极接触的要求进行了更新，并提出了对可维护性和操作人员的要求。此外，IEC 60601-1标准还对设备进行了一些分类和标记要求。标准对各种不同类型的医用电气设备进行了分类，根据它们的安全风险等级进行了不同的要求。同时，标准要求对设备进行适当的标记，以便操作者和用户了解设备的安全性能和用途。总的来说，IEC 60601-1标准为医用电气设备的安全性和性能提供了一系列严格的要求。这些要求对设备制造商、操作人员和用户来说都是很重要的，因为它们可以确保设备在医疗环境中的安全和有效的使用。 IEC 60601-1-2012版本3.1是目前该标准的最新修订版，它对之前的标准进行了一些改进和更新。修订版的引入，使得IEC 60601-1标准能够适应不断发展的医疗设备技术和市场需求，确保医疗设备在安全和性能方面达到最高标准。

– 14 – 60601-1  IEC:2005+A1:2012(E)

INTRODUCTION

In 1976, IEC subcommittee 62A published the first edition of IEC/TR 60513, Basic aspects of

the safety philosophy for electrical equipment used in medical practice. The first edition of

IEC/TR 60513 provided the basis for developing:

– the first edition of IEC 60601-1 (the parent safety standard for

MEDICAL ELECTRICAL

EQUIPMENT

);

– the IEC 60601-1-xx series of collateral standards for

MEDICAL ELECTRICAL EQUIPMENT;

– the IEC 60601-2-xx series of particular standards for particular types of

MEDICAL

ELECTRICAL EQUIPMENT

; and

– the IEC 60601-3-xx series of performance standards for particular types of

MEDICAL

ELECTRICAL EQUIPMENT

Aware of the need and the urgency for a standard covering electrical equipment used in

medical practice, the majority of National Committees voted in 1977 in favour of the first

edition of IEC 60601-1, based on a draft that at the time represented a first approach to the

problem. The extent of the scope, the complexity of the equipment concerned, and the

specific nature of some of the protective measures and the corresponding tests for verifying

them, required years of effort in order to prepare this first standard, which can now be said to

have served as a universal reference since its publication.

However, the frequent application of the first edition revealed room for improvement. These

improvements were all the more desirable in view of the considerable success that this

standard has enjoyed since its publication.

The careful work of revision subsequently undertaken and continued over a number of years

resulted in the publication of the second edition in 1988. This edition incorporated all the

improvements that could be reasonably expected up to that time. Further developments

remained under constant study. The second edition was amended in 1991 and then again in

1995.

The original IEC approach was to prepare separate

BASIC SAFETY and performance standards

for

MEDICAL ELECTRICAL EQUIPMENT. This was a natural extension of the historical approach

taken at the national and international level with other electrical equipment standards (e.g.

those for domestic equipment), where

BASIC SAFETY is regulated through mandatory standards

but other performance specifications are regulated by market pressure. In this context, it has

been said that, “The ability of an electric kettle to boil water is not critical to its safe use!”

It is now recognized that this is not the situation with many items of

MEDICAL ELECTRICAL

EQUIPMENT

, and RESPONSIBLE ORGANIZATIONS have to depend on standards to ensure

ESSENTIAL PERFORMANCE as well as BASIC SAFETY. Such areas include the accuracy with which

the equipment controls the delivery of energy or therapeutic substances to the

PATIENT, or

processes and displays physiological data that will affect

PATIENT management.

This recognition means that separating

BASIC SAFETY and performance is somewhat

inappropriate in addressing the

HAZARDS that result from inadequate design of MEDICAL

ELECTRICAL EQUIPMENT

. Many particular standards in the IEC 60601-2-xx series address a

range of

ESSENTIAL PERFORMANCE requirements that cannot be directly evaluated by the

RESPONSIBLE ORGANIZATION without applying such standards. (However, the current IEC 60601

series includes fewer requirements for

ESSENTIAL PERFORMANCE than for BASIC SAFETY).

60601-1  IEC:2005+A1:2012(E) – 15 –

In anticipation of a third edition of IEC 60601-1, IEC subcommittee 62A prepared a second

edition of IEC/TR 60513 [12]

in 1994. It was intended that the second edition of IEC/TR

60513 would provide guidance for developing this edition of IEC 60601-1, and for the further

development of the IEC 60601-1-xx and IEC 60601-2-xx series.

In order to achieve consistency in international standards, address present expectations in

the health care community and align with developments in IEC 60601-2-xx, the second edition

of IEC/TR 60513 includes two major new principles:

– the first change is that the concept of “

SAFETY” has been broadened from the BASIC SAFETY

considerations in the first and second editions of IEC 60601-1 to include

ESSENTIAL

PERFORMANCE

matters, (e.g. the accuracy of physiological monitoring equipment).

Application of this principle leads to the change of the title of this publication from “Medical

electrical equipment, Part 1: General requirements for safety” in the second edition, to

“Medical electrical equipment, Part 1: General requirements for basic safety and essential

performance”;

– the second change is that, in specifying minimum safety requirements, provision is made

for assessing the adequacy of the design

PROCESS when this is the only practical method

of assessing the safety of certain technologies such as programmable electronic systems.

Application of this principle is one of the factors leading to introduction of a general

requirement to carry out a

RISK MANAGEMENT PROCESS. In parallel with the development of

the third edition of IEC 60601-1, a joint project with ISO/TC 210 resulted in the publication

of a general standard for

RISK MANAGEMENT of medical devices. Compliance with this

edition of IEC 60601-1 requires that the

MANUFACTURER have in place a RISK MANAGEMENT

PROCESS

complying with parts of ISO 14971 (see 4.2).

This standard contains requirements concerning BASIC SAFETY and ESSENTIAL PERFORMANCE

that are generally applicable to

MEDICAL ELECTRICAL EQUIPMENT. For certain types of MEDICAL

ELECTRICAL EQUIPMENT

, these requirements are either supplemented or modified by the special

requirements of a collateral or particular standard. Where particular standards exist, this

standard should not be used alone.

Amendment 1 to this standard is intended to address:

– issues identified by National Committees and other interested parties since the publication

of IEC 60601-1:2005;

– the way in which RISK MANAGEMENT has been introduced into IEC 60601-1:2005; and

– the way the concept of ESSENTIAL PERFORMANCE is used in IEC 60601-1:2005.

___________

1) Figures in square brackets refer to the Bibliography.

60601-1  IEC:2005+A1:2012(E) – 17 –

MEDICAL ELECTRICAL EQUIPMENT –

Part 1: General requirements for basic safety

and essential performance

1 Scope, object and related standards

1.1 * Scope

This International Standard applies to the

BASIC SAFETY and ESSENTIAL PERFORMANCE of

MEDICAL ELECTRICAL EQUIPMENT and MEDICAL ELECTRICAL SYSTEMS, hereafter referred to as

ME EQUIPMENT and ME SYSTEMS.

If a clause or subclause is specifically intended to be applicable to

ME EQUIPMENT only, or to

ME SYSTEMS only, the title and content of that clause or subclause will say so. If that is not the

case, the clause or subclause applies both to

ME EQUIPMENT and to ME SYSTEMS, as relevant.

AZARDS inherent in the intended physiological function of ME EQUIPMENT or ME SYSTEMS within

the scope of this standard are not covered by specific requirements in this standard except in

7.2.13 and 8.4.1.

NOTE 1 See also 4.2.

This standard can also be applied to equipment used for compensation or alleviation of

disease, injury or disability.

In vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT is

covered by the IEC 61010 series

. This standard does not apply to the implantable parts of

active implantable medical devices covered by ISO 14708-1

The IEC 60601 series does not apply to:

– in vitro diagnostic equipment that does not fall within the definition of ME EQUIPMENT, which

is covered by the IEC 61010 series [61];

– implantable parts of active implantable medical devices covered by the ISO 14708

series [69]; or

– medical gas pipeline systems covered by ISO 7396-1 [68].

NOTE 2 ISO 7396-1 applies the requirement of IEC 60601-1-8 to certain monitoring and ALARM SIGNALS.

1.2 Object

The object of this standard is to specify general requirements and to serve as the basis for

particular standards.

1.3 * Collateral standards

In the IEC 60601 series, collateral standards specify general requirements for

BASIC SAFETY

and

ESSENTIAL PERFORMANCE applicable to:

– a subgroup of

ME EQUIPMENT (e.g. radiological equipment);

– a specific characteristic of all

ME EQUIPMENT not fully addressed in this standard.

Applicable collateral standards become normative at the date of their publication and shall

apply together with this standard.

___________

IEC 61010 (all parts), Safety requirements for electrical equipment for measurement, control, and laboratory

use

ISO 14708-1, Implants for surgery – Active implantable medical devices – Part 1: General requirements for

safety, marking and for information to be provided by the manufacturer

– 18 – 60601-1  IEC:2005+A1:2012(E)

NOTE 1 When evaluating compliance with IEC 60601-1, it is permissible to independently assess compliance with

the collateral standards.

NOTE 2 When declaring compliance with IEC 60601-1, the declarer should specifically list the collateral standards

that have been applied. This allows the reader of the declaration to understand which collateral standards were

part of the evaluation.

NOTE 3 Collateral standards in the IEC 60601 family are numbered IEC 60601-1-xx. Members of The IEC

maintains a register catalogue of valid International Standards. Users of this standard should consult this register

catalogue at "http://webstore.iec.ch" to determine which collateral standards have been published.

If a collateral standard applies to ME EQUIPMENT for which a particular standard exists, then

the particular standard takes priority over the collateral standard.

1.4 * Particular standards

In the IEC 60601 series, particular standards may modify, replace or delete requirements

contained in this standard as appropriate for the particular

ME EQUIPMENT under consideration,

and may add other

BASIC SAFETY and ESSENTIAL PERFORMANCE requirements.

NOTE Members of IEC and ISO maintain registers of valid International Standards. Users of this standard should

consult these registers to determine which particular standards have been published. Particular standards in the

IEC 60601 family that are developed by IEC committees are numbered IEC 60601-2-xx. In addition, particular

standards developed by joint projects between ISO and IEC can be numbered either IEC 80601-2-xx or ISO 80601-

2-xx depending on which committee administered the project. IEC and ISO maintain catalogues of valid

International Standards. Users of this standard should consult these catalogues at "http://webstore.iec.ch" and

"http://www.iso.org/iso/store.htm" to determine which particular standards have been published.

A requirement of a particular standard takes priority over this standard.

2 * Normative references

The following referenced documents are indispensable for the application of this document.

For dated references, only the edition cited applies. For undated references, the latest edition

of the referenced document (including any amendments) applies.

ATTENTION: Additional collateral standards of the IEC 60601 series,

which are issued

subsequent to publication of this standard, become normative at the date of their publication

and shall be considered as being included among the normative references below. See 1.3.

NOTE Informative references are listed in the Bibliography on page 396.

IEC 60065:2001, Audio, video and similar electronic apparatus – Safety requirements

)

Amendment 1:2005

Amendment 2:2010

IEC 60068-2-2:1974 2007, Environmental testing – Part 2-2: Tests – Test B: Dry heat

Amendment 1 (1993)

Amendment 2 (1994)

IEC 60079-0, Electrical apparatus for explosive gas atmospheres – Part 0: General

requirements

IEC 60079-2, Electrical apparatus for explosive gas atmospheres – Part 2: Pressurized

enclosures “p”

IEC 60079-5, Electrical apparatus for explosive gas atmospheres – Part 5: Powder filling “q”

IEC 60079-6, Electrical apparatus for explosive gas atmospheres – Part 6: Oil-immersion “o”

IEC 60083, Plugs and socket-outlets for domestic and similar general use standardized in

member countries of IEC

___________

There exists a consolidated edition 7.2 including IEC 60065:2001 and its Amendment 1 (2005) and

Amendment 2 (2010).

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