|
IEC 60601-1
Edition 3.0 2020-08
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 2
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
IEC 60601-1: 2005-12/AMD2: 2020-07(en)
your local IEC member National Committee for further information.
IEC Central Office Tel.: +41 22 919 02 11
3, rue de
CH-1211 Geneva 20
Switzerland
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 technologies.
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 corrigendum or an amendment might have been published.
IEC publications search - webstore.iec.ch/advsearchform Electropedia - www.electropedia.org
The advanced search enables to find IEC publications by a The world's leading online dictionary on electrotechnology,
variety of criteria (reference number, text, technical containing more than 22 000 terminological entries in English
committee,…). It also gives information on projects, replaced and French, with equivalent terms in 16 additional languages.
and withdrawn publications. Also known as the International Electrotechnical Vocabulary
(IEV) online.
IEC Just Published - webstore.iec.ch/justpublished
Stay up to date on all new IEC publications. Just Published IEC Glossary - std.iec.ch/glossary
details all new publications released. Available online and 67 000 electrotechnical terminology entries in English and
once a month by email. French extracted from the Terms and definitions clause of
IEC publications issued between 2002 and 2015. Some
IEC Customer Service Centre - webstore.iec.ch/csc entries have been collected from earlier publications of IEC
If you wish to give us your feedback on this publication or TC 37, 77, 86 and CISPR.
need further assistance, please contact the Customer Service
.
IEC 60601-1
Edition 3.0 2020-08
INTERNATIONAL
STANDARD
colour
inside
AMENDMENT 2
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
ICS 11.040.01 ISBN 978-2-8322-8632-6
– 2 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
FOREWORD
This amendment has been prepared by subcommittee 62A: Common aspects of electrical
equipment used in medical practice, of IEC technical committee 62: Electrical equipment in
medical practice.
The text of this amendment is based on the following documents:
FDIS Report on voting
62A/1389/FDIS 62A/1404/RVD
Full information on the voting for the approval of this amendment can be found in the report on
voting indicated in the above table.
The committee has decided that the contents of this amendment and the base publication will
remain unchanged until the stability date indicated on the IEC web site under
"http://webstore.iec.ch" in the data related to the specific publication. At this date, the
publication will be
• reconfirmed,
• withdrawn,
• replaced by a revised edition, or
• amended.
NOTE The attention of the users of this document is drawn to the fact that equipment manufacturers and testing
organizations may need a transitional period following publication of a new, amended or revised IEC or ISO
publication in which to make products in accordance with the new requirements and to equip themselves for
conducting new or revised tests. It is the recommendation of the committee that the content of this publication be
adopted for mandatory implementation nationally not earlier than 3 years from the date of publication.
IMPORTANT – The 'colour inside' logo on the cover page of this publication indicates
that it contains colours which are considered to be useful for the correct understanding
of its contents. Users should therefore print this document using a colour printer.
_____________
© IEC 2020
INTRODUCTION TO AMENDMENT 2
The third edition of IEC 60601-1 was published in 2005 and amended in 2012. Since the
publication of IEC 60601-1:2005/AMD1:2012, the IEC Subcommittee (SC) 62A Secretariat has
been collecting issues from a variety of sources including comments from National Committees
and questions submitted to IEC/SC 62A/Working Group (WG) 14. At the November 2015
meeting of IEC/SC 62A in Kobe, Japan, the subcommittee initiated a process to identify high-
priority issues that need to be considered in Amendment 2 and should not wait until the fourth
edition of IEC 60601-1, which is presently targeted for publication sometime after 2024.
Those issues selected for inclusion on the final "short list" to be addressed in Amendment 2
were those approved by a 2/3 majority of the National Committees present and voting at the
Frankfurt meeting of SC 62A. At the meeting held on 10 October 2016, 109 items were
presented to the National Committees present. A total of 78 items received the required 2/3
majority of the National Committees present and voting and were included in the "short list" for
consideration in preparing Amendment 2. All remaining issues have been placed on a "long list"
for consideration in the fourth edition of IEC 60601-1.
The "short list" of issues was documented in the design specification for Amendment 2. The
responsible expert groups were directed to consider each issue assigned to it in Clause 6 of
the design specification and develop an appropriate solution for the identified problem. That
final solution in this amendment can encompass any technical solution proposed by the author
of the issue or it can involve a different solution developed by the expert group. The expert
group can also have recommended that no change to the standard was justified by the problem
statement.
Because this is an amendment to the 2005 edition of IEC 60601-1, the style in force at the time
of publication of IEC 60601-1 has been applied to this amendment. The style specified in
ISO/IEC Directives, Part 2:2018 has only been applied when implementing the new style
guidance would not result in additional editorial changes. For example, notes to definitions are
designated as "NOTE" rather than "Note to entry" in Clause 3.
Users of this document should note that when constructing the dated references to specific
elements in a standard, such as definitions, amendments are only referenced if they modified
the text being cited. For example, if a reference is made to a definition that has not been
modified by an amendment, then the reference to the amendment is not included in the dated
reference.
– 4 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
INTRODUCTION
Add, after the existing last paragraph, the following paragraph:
Throughout this document, there are many references to, and requirements incorporated from
IEC 60950-1. Some of these requirements are derived from IEC 60950-1. For example, the
requirements for spaces filled by insulating compound in 8.9.3. In other cases, the requirements
are incorporated by a normative reference to IEC 60950-1:2005. For example, the requirements
for solid insulation forming a MEANS OF OPERATOR PROTECTION in 8.5.1.3. The requirements
incorporated by reference are primarily found in Clause 8 of this document, including many of
the tables used to determine the requirements for MEANS OF PROTECTION, primarily MEANS OF
OPERATOR PROTECTION and INSULATION CO-ORDINATION. The requirements incorporated by
reference are addressed in Amendment 2. The derived requirements will be addressed during
the development of the fourth edition of this document.
1.3 * Collateral standards
Replace the existing second paragraph with:
Applicable collateral standards shall apply together with this standard.
Delete the existing third paragraph.
1.4 * Particular standards
Replace the existing first paragraph with:
In the IEC 60601 series, particular standards specify BASIC SAFETY and ESSENTIAL PERFORMANCE
requirements for the particular ME EQUIPMENT and ME SYSTEMS. Particular standards may
modify, replace or delete requirements contained in this standard and applicable collateral
standards as appropriate for the particular ME EQUIPMENT and ME SYSTEMS under consideration.
Replace the existing second paragraph with:
A requirement of a particular standard takes priority over this standard and applicable collateral
standards.
2 * Normative references
Replace the existing second paragraph with:
ATTENTION: Additional collateral standards of the IEC 60601 series, which are issued subsequent
to publication of this standard, shall apply together with this standard when applicable. They shall
be considered as being included among the normative references below. See 1.3.
Replace the following existing references to IEC 60601-1-2, IEC 60601-1-3 modified by
Amendment 1, IEC 60601-1-6 and IEC 60601-1-8 by the following new references:
IEC 60601-1-2:2014, Medical electrical equipment – Part 1-2: General requirements for basic
safety and essential performance – Collateral standard: Electromagnetic disturbances –
Requirements and tests
Amendment 1:2020
IEC 60601-1-3:2008, Medical electrical equipment – Part 1-3: General requirements for basic
safety and essential performance – Collateral Standard: Radiation protection in diagnostic X-
ray equipment
Amendment 1:2013
© IEC 2020
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
Amendment 1:2013
Amendment 2:2020
IEC 60601-1-8:2006, Medical electrical equipment – Part 1-8: General requirements for basic
safety and essential performance – Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical systems
Amendment 1:2012
Amendment 2:2020
Add the following new reference to the list:
IEC 60747-5-5:2007, Semiconductor devices – Discrete devices – Part 5-5: Optoelectronic
devices – Photocouplers
Replace, in the existing reference to IEC 60825-1,"2007" with "2014".
Replace the existing references to IEC 60950-1 and IEC 62304 by the following new references:
IEC 60950-1:2005, Information technology equipment – Safety – Part 1: General requirements
Amendment 1:2009
Amendment 2:2013
IEC 62304:2006, Medical device software – Software life cycle processes
Amendment 1:2015
Add the following normative references to the existing list:
IEC 62133-2, Secondary cells and batteries containing alkaline or other non-acid electrolytes –
Safety requirements for portable sealed secondary lithium cells, and for batteries made from
them, for use in portable applications – Part 2: Lithium systems
IEC 62368-1:2018, Audio/video, information and communication technology equipment –
Part 1: Safety requirements
Replace the existing references to ISO 7000-DB:2004 by the following new reference:
ISO 7000, Graphical symbols for use on equipment
Replace, in the existing reference to ISO 7010, "2011" with "2019".
Replace, in the existing reference to ISO 14971, "2007" with "2019".
Replace, in the existing reference to ISO 15223-1, "2012" with "2016".
3 * Terminology and definitions
3.38
* HARM
Replace the existing term and definition, modified by Amendment 1, with:
3.38
* HARM
injury or damage to the health of people or animals, or damage to property or the environment
[ISO 14971:2019, definition 3.3, modified – "Or animals" added to the definition.]
– 6 – IEC 60601-1:2005/AMD2:2020
© IEC 2020
3.39
HAZARD
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.4]
3.40
* HAZARDOUS SITUATION
Replace the existing term and definition, modified by Amendment 1, with:
3.40
* HAZARDOUS SITUATION
circumstance in which people, property, or the environment is/are exposed to one or more
HAZARDS
[ISO 14971:2019, definition 3.5, modified – Note 1 to entry deleted.]
3.44
INTENDED USE
INTENDED PURPOSE
Replace the existing term and definition, modified by Amendment 1, with:
3.44
INTENDED USE
INTENDED PURPOSE
use for which a product, PROCESS or service is intended according to the specifications,
instructions and information provided by the MANUFACTURER
NOTE 1 The intended medical indication, PATIENT population, part of the body or type of tissue interacted with, user
profile, use environment, and operating principle are typical elements of the INTENDED USE.
NOTE 2 INTENDED USE should not be confused with NORMAL USE. While both include the concept of use as intended
by the MANUFACTURER, INTENDED USE focuses on the medical purpose while NORMAL USE incorporates not only the
medical purpose, but maintenance, transport, etc. as well.
[ISO 14971:2019, definition 3.6, modified – Note 2 added.]
3.55
MANUFACTURER
Replace the existing term and definition, modified by Amendment 1, with:
3.55
MANUFACTURER
natural or legal person with responsibility for the design, manufacture, packaging, or labelling
of ME EQUIPMENT, assembling an ME SYSTEM, or adapting ME EQUIPMENT or an ME SYSTEM,
regardless of whether these operations are performed by that person himself or on his behalf
by another person(s)
NOTE 1 ISO 13485 [30] defines “labelling” as "label, instructions for use, and any other information that is related
to identification, technical description, INTENDED PURPOSE and proper use of the ME EQU
...