SIST EN 60601-1:2007/A2:2021
(Amendment)Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)
Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601-1:2005/A2:2020)
2021-08-25-JO: BT Decision (BT169/DG12292/DV) to remove the link to the MDR
2021-06-24: blocked so that the link to the MDD can be removed by BT from the document
2019-12-03-JO-Assessment at ENQ uplaoded with due date of 06 Jan.2020 plus extention requested by HAS Consultant
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit einschließlich der wesentlichen Leistungsmerkmale (IEC 60601-1:2005/A2:2020)
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et les performances essentielles (IEC 60601-1:2005/A2:2020)
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in bistvene zmogljivosti - Dopolnilo A2 (IEC 60601-1:2005/A2:2020)
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN 60601-1:2007/A2:2021
01-december-2021
Medicinska električna oprema - 1. del: Splošne zahteve za osnovno varnost in
bistvene zmogljivosti - Dopolnilo A2 (IEC 60601-1:2005/A2:2020)
Medical electrical equipment - Part 1: General requirements for basic safety and
essential performance (IEC 60601-1:2005/A2:2020)
Medizinische elektrische Geräte - Teil 1: Allgemeine Festlegungen für die Sicherheit
einschließlich der wesentlichen Leistungsmerkmale (IEC 60601-1:2005/A2:2020)
Appareils électromédicaux - Partie 1: Exigences générales pour la sécurité de base et
les performances essentielles (IEC 60601-1:2005/A2:2020)
Ta slovenski standard je istoveten z: EN 60601-1:2006/A2:2021
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
SIST EN 60601-1:2007/A2:2021 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
---------------------- Page: 1 ----------------------
SIST EN 60601-1:2007/A2:2021
---------------------- Page: 2 ----------------------
SIST EN 60601-1:2007/A2:2021
EUROPEAN STANDARD EN 60601-1:2006/A2
NORME EUROPÉENNE
EUROPÄISCHE NORM
October 2021
ICS 11.040.01
English Version
Medical electrical equipment - Part 1: General requirements for
basic safety and essential performance
(IEC 60601-1:2005/A2:2020)
Appareils électromédicaux - Partie 1: Exigences générales Medizinische elektrische Geräte - Teil 1: Allgemeine
pour la sécurité de base et les performances essentielles Festlegungen für die Basissicherheit einschließlich der
(IEC 60601-1:2005/A2:2020) wesentlichen Leistungsmerkmale
(IEC 60601-1:2005/A2:2020)
This amendment A2 modifies the European Standard EN 60601-1:2006; it was approved by CENELEC on 2020-09-24. CENELEC
members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this amendment the
status of a national standard without any alteration.
Up-to-date lists and bibliographical references concerning such national standards may be obtained on application to the CEN-CENELEC
Management Centre or to any CENELEC member.
This amendment exists in three official versions (English, French, German). A version in any other language made by translation under the
responsibility of a CENELEC member into its own language and notified to the CEN-CENELEC Management Centre has the same status as
the official versions.
CENELEC members are the national electrotechnical committees of Austria, Belgium, Bulgaria, Croatia, Cyprus, the Czech Republic,
Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, the
Netherlands, Norway, Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland,
Turkey and the United Kingdom.
European Committee for Electrotechnical Standardization
Comité Européen de Normalisation Electrotechnique
Europäisches Komitee für Elektrotechnische Normung
CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2021 CENELEC All rights of exploitation in any form and by any means reserved worldwide for CENELEC Members.
Ref. No. EN 60601-1:2006/A2:2021 E
---------------------- Page: 3 ----------------------
SIST EN 60601-1:2007/A2:2021
EN 60601-1:2006/A2:2021 (E)
European foreword
The text of document 62A/1389/FDIS, future IEC 60601-1/A2, prepared by SC 62A "Common aspects
of electrical equipment used in medical practice" of IEC/TC 62 "Electrical equipment in medical
practice" was submitted to the IEC-CENELEC parallel vote and approved by CENELEC as
EN 60601-1:2006/A2:2021.
The following dates are fixed:
• latest date by which the document has to be implemented at national (dop) 2022-04-08
level by publication of an identical national standard or by endorsement
• latest date by which the national standards conflicting with the (dow) 2024-10-08
document have to be withdrawn
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CENELEC shall not be held responsible for identifying any or all such patent rights.
Any feedback and questions on this document should be directed to the users’ national committee. A
complete listing of these bodies can be found on the CENELEC website.
Endorsement notice
The text of the International Standard IEC 60601-1:2005/A2:2020 was approved by CENELEC as a
European Standard without any modification.
In the official version, for Bibliography, the following notes have to be added for the standards
indicated:
IEC 60601-2-57 NOTE Harmonized as EN 60601-2-57
IEC 62366-1:2015 NOTE Harmonized as EN 62366-1:2015 (not modified)
ISO 2409 NOTE Harmonized as EN ISO 2409
ISO 4624 NOTE Harmonized as EN ISO 4624
ISO 10524-1:2018 NOTE Harmonized as EN ISO 10524-1:2019 (not modified)
ISO 13732-1:2006 NOTE Harmonized as EN ISO 13732-1:2008 (not modified)
2
---------------------- Page: 4 ----------------------
SIST EN 60601-1:2007/A2:2021
EN 60601-1:2006/A2:2021 (E)
Annex ZA
(normative)
Normative references to international publications
with their corresponding European publications
The following documents are referred to in the text in such a way that some or all of their content
constitutes requirements 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.
NOTE 1 Where an International Publication has been modified by common modifications, indicated by (mod),
the relevant EN/HD applies.
NOTE 2 Up-to-date information on the latest versions of the European Standards listed in this annex is
available here: www.cenelec.eu.
Replace Annex ZA by the following one:
Publication Year Title EN/HD Year
IEC 60065 2001 Audio, video and similar electronic - -
apparatus - Safety requirements
+ A1 2005 - -
+ A2 2010 - -
IEC 60068-2-2 2007 Environmental testing - Part 2-2: Tests - EN 60068-2-2 2007
Test B: Dry heat
IEC 60079-0 - Explosive atmospheres - Part 0: EN IEC 60079-0 -
Equipment - General requirements
IEC 60079-2 - Explosive atmospheres - Part 2: EN 60079-2 -
Equipment protection by pressurized
enclosure "p"
IEC 60079-5 - Explosive atmospheres - Part 5: EN 60079-5 -
Equipment protection by powder filling "q"
IEC 60079-6 - Explosive atmospheres - Part 6: EN 60079-6 -
Equipment protection by liquid immersion
"o"
IEC 60083 - Plugs and socket-outlets for domestic - -
and similar general use standardized in
member countries of IEC
IEC 60085 - Electrical insulation - Thermal evaluation EN 60085 -
and designation
IEC 60086-4 - Primary batteries - Part 4: Safety of EN IEC 60086-4 -
lithium batteries
IEC 60112 - Method for the determination of the proof EN IEC 60112 -
and the comparative tracking indices of
solid insulating materials
IEC 60127-1 - Miniature fuses - Part 1: Definitions for EN 60127-1 -
miniature fuses and general requirements
for miniature fuse-links
IEC 60227-1 2007 Polyvinyl chloride insulated cables of - -
rated voltages up to and including
450/750 V - Part 1: General requirements
3
---------------------- Page: 5 ----------------------
SIST EN 60601-1:2007/A2:2021
EN 60601-1:2006/A2:2021 (E)
Publication Year Title EN/HD Year
IEC 60245-1 2003 Rubber insulated cables - Rated voltages - -
up to and including 450/750 V -- Part 1:
General requirements
+ A1 2007 - -
IEC 60252-1 - AC motor capacitors - Part 1: General - EN 60252-1 -
Performance, testing and rating - Safety
requirements - Guidance for installation
and operation
IEC 60320-1 - Appliance couplers for household and EN 60320-1 -
similar general purposes - Part 1:
General requirements
IEC 60335-1 (mod) 2010 Household and similar electrical EN 60335-1 2012
appliances - Safety - Part 1: General
requirements
- - + A11 2014
- - + AC 2014
- - + A13 2017
- - + A14 2019
- - + A15 2021
IEC 60364-4-41 - Low-voltage electrical installations - Part HD 60364-4-41 -
4-41: Protection for safety - Protection
against electric shock
IEC 60384-14 2005 Fixed capacitors for use in electronic - -
equipment -- Part 14: Sectional
specification - Fixed capacitors for
electromagnetic interference suppression
and connection to the supply mains
IEC 60417 - Graphical symbols for use on equipment. - -
Index, survey and compilation of the
single sheets.
IEC 60445 - Basic and safety principles for man- - -
machine interface, marking and
identification – Identification of equipment
terminals and of terminations of certain
designated conductors, including general
rules for an alphanumeric system
IEC 60447 - Basic and safety principles for man- EN 60447 -
machine interface, marking and
identification - Actuating principles
IEC 60529 1989 Degrees of protection provided by EN 60529 1991
enclosures (IP Code)
- - + corrigendum 1993
May
IEC 60601-1-2 2014 Medical electrical equipment - Part 1-2: EN 60601-1-2 2015
General requirements for basic safety
and essential performance - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests
+ A1 2020 + A1 2021
IEC 60601-1-3 2008 Medical electrical equipment - Part 1-3: EN 60601-1-3 2008
General requirements for basic safety
and essential performance - Collateral
Standard: Radiation protection in
diagnostic X-ray equipment
4
---------------------- Page: 6 ----------------------
SIST EN 60601-1:2007/A2:2021
EN 60601-1:2006/A2:2021 (E)
Publication Year Title EN/HD Year
- - + corrigendum 2010
Mar.
+ A1 2013 + A1 2013
- - + AC 2014
- - + A11 2016
IEC 60601-1-6 2010 Medical electrical equipment - Part 1-6: EN 60601-1-6 2010
General requirements for basic safety
and essential performance - Collateral
standard: Usability
+ A1 2013 + A1 2015
+ A2 2020 + A2 2021
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
+ A1 2012 + A1 2013
- - + AC 2014
+ A2 2020 + A2 2021
IEC 60664-1 2007 Insulation coordination for equipment EN 60664-1 2007
within low-voltage systems - Part 1:
Principles, requirements and tests
IEC 60695-11-10 - Fire hazard testing - Part 11-10: Test EN 60695-11-10 -
flames - 50 W horizontal and vertical
flame test methods
IEC 60730-1 (mod) 2010 Automatic electrical controls for EN 60730-1 2011
household and similar use -- Part 1:
General requirements
IEC 60747-5-5 2007 Semiconductor devices - Discrete EN 60747-5-5 2011
devices - Part 5-5: Optoelectronic
devices - Photocouplers
IEC 60825-1 2014 Safety of laser products - Part 1: EN 60825-1 2014
Equipment classification and
requirements
- - + A11 2021
- - /AC 2017
IEC 60851-3 2009 Winding wires - Test methods - Part 3: EN 60851-3 2009
Mechanical properties
IEC 60851-5 2008 Winding wires - Test methods - Part 5: EN 60851-5 2008
Electrical properties
IEC 60851-6 1996 Winding wires - Test methods -- Part 6: - -
Thermal properties
IEC 60884-1 - Plugs and socket-outlets for household - -
and similar purposes -- Part 1: General
requirements
IEC 60950-1 2005 Information technology equipment - - -
Safety - Part 1: General requirements
+ A1 2009 - -
+ A2 2013 - -
5
---------------------- Page: 7 ----------------------
SIST EN 60601-1:2007/A2:2021
EN 60601-1:2006/A2:2021 (E)
Publication Year Title EN/HD Year
IEC 61058-1 2000 Switches for appliances -- Part 1: - -
General requirements
+ A1 2001 - -
+ A2 2007 - -
IEC 61558-2-1 - Safety of power transformers, power EN 61558-2-1 -
supplies, reactors and similar products -
Part 2-1: Particular requirements and
tests for separating transformers and
power supplies incorporating separating
transformers for general applications
IEC 61672-1 - Electroacoustics - Sound level meters - EN 61672-1 -
Part 1: Specifications
IEC 61672-2 - Electroacoustics - Sound level meters - EN 61672-2 -
Part 2: Pattern evaluation tests
IEC 61965 - Mechanical safety of cathode ray tubes EN 61965 -
IEC 62133 - Secondary cells and batteries containing - -
alkaline or other non-acid electrolytes -
Safety requirements for portable sealed
secondary cells, and for batteries made
from them, for use in portable
applications
IEC 62133-2 - Secondary cells and batteries containing EN 62133-2 -
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 62304 2006 Medical device software - Software life EN 62304 2006
cycle processes
- - + corrigendum 2008
Nov.
IEC 62368-1 2018 Audio/video, information and EN IEC 62368-1 2020
communication technology equipment -
Part 1: Safety requirements
ISO 780 - Packaging – Pictorial marking for EN ISO 780 -
handling of goods
ISO 1853 - Conducting and dissipative rubbers, - -
vulcanized or thermoplastic -
Measurement of resistivity
ISO 2878 - Rubber, vulcanized or thermoplastic - - -
Antistatic and conductive products -
Determination of electrical resistance
ISO 2882 - Rubber, vulcanized - Antistatic and - -
conductive products for hospital use -
Electrical resistance limits
ISO 3746 - Acoustics - Determination of sound EN ISO 3746 -
power levels and sound energy levels of
noise sources using sound pressure -
Survey method using an enveloping
measurement surface over a reflecting
plane
6
---------------------- Page: 8 ----------------------
SIST EN 60601-1:2007/A2:2021
EN 60601-1:2006/A2:2021 (E)
Publication Year Title EN/HD Year
ISO 3864-1 2002 Graphical symbols - Safety colours and - -
safety signs – Part 1: Design principles
for safety signs in workplaces and public
areas
ISO 5349-1 - Mechanical vibration - Measurement and EN ISO 5349-1 -
evaluation of human exposure to hand-
transmitted vibration – Part 1: General
requirements
ISO 7000 - Graphical symbols for use on equipment - -
- Registered symbols
ISO 7010 2019 Graphical symbols - Safety colours and - -
safety signs - Registered safety signs
ISO 9614-1 - Acoustics - Determination of sound EN ISO 9614-1 -
power levels of noise sources using
sound intensity - Part 1: Measurement at
discrete points
ISO 10993 series Biological evaluation of medical devices EN ISO 10993 series
ISO 11135-1 2007 Sterilization of health care products - - -
Ethylene oxide – Part 1: Requirements
for development, validation and routine
control of a sterilization process for
medical devices
ISO 11137-1 2006 Sterilization of health care products - EN ISO 11137-1 2015
Radiation – Part 1: Requirements for
development, validation and routine
control of a sterilization process for
medical devices
ISO 13857 2008 Safety of machinery - Safety distances to - -
prevent hazard zones being reached by
upper and lower limbs
ISO 14971 2019 Medical devices – Application of risk EN ISO 14971 2019
management to medical devices
ISO 15223-1 2016 Medical devices – Symbols to be used EN ISO 15223-1 2016
with medical device labels, labelling and
information to be supplied – Part 1:
General requirements
ISO 17665-1 2006 Sterilization of health care products - EN ISO 17665-1 2006
Moist heat – Part 1: Requirements for the
development, validation and routine
control of a sterilization process for
medical devices
ISO 23529 - Rubber - General procedures for - -
preparing and conditioning test pieces for
physical test methods
ISO 80000-1 2009 Quantities and units -- Part 1: General EN ISO 80000-1 2013
7
---------------------- Page: 9 ----------------------
SIST EN 60601-1:2007/A2:2021
---------------------- Page: 10 ----------------------
SIST EN 60601-1:2007/A2:2021
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
Warning! Make sure that you obtained this publication from an authorized distributor.
® Registered trademark of the International Electrotechnical Commission
---------------------- Page: 11 ----------------------
SIST EN 60601-1:2007/A2:2021
– 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.
_____________
---------------------- Page: 12 ----------------------
SIST EN 60601-1:2007/A2:2021
IEC 60601-1:2005/AMD2:2020 – 3 –
© 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.
---------------------- Page: 13 ----------------------
SIST EN 60601-1:2007/A2:2021
– 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
---------------------- Page: 14 ----------------------
SIST EN 60601-1:2007/A2:2021
IEC 60601-1:2005/AMD2:2020 – 5 –
© 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.]
---------------------- Page: 15 ----------------------
SIST EN 60601-1:2007/A2:2021
– 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 EQUIPMENT or ME SYSTEM, but
excluding shipping documents".
NOTE 2 “Adapting” includes making substantial modifications to ME EQUIPMENT or an ME SYSTEM already in use.
NOTE 3 In some jurisdictions, the RESPONSIBLE ORGANIZATION can be considered a MANUFACTURER when involved
in the activities described.
NOTE 4 Adapted from ISO 14971:2019, definition 3.9.
---------------------- Page: 16 ----------------------
SIST EN 60601-1:2007/A2:2021
IEC 60601-1:2005/AMD2:2020 – 7 –
© IEC 2020
3.72
OBJECTIVE EVIDENCE
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.11]
3.88
PROCEDURE
Replace the existing source statement for definition, modified by Amendment 1, with:
[ISO 14971:2019, definition 3.13, modified – Note 1 to entry deleted.]
3.89
PROCESS
Replace the existing term and definition, modified by Amendment 1, with:
3.89
PROCESS
set of interrelated or interacting activities that use inputs to deliver an intended result
NOTE 1 Whether the “intended result” of a PROCESS is called output, product or service depends on the context of
the reference.
NOTE 2 Inputs to a PROCESS are generally the outputs of other PROCESSES and outputs of a PROCESS are generally
the inputs to other PROCESSES.
NOTE 3 Two or more interrelated and interacting PROCESSES in series can also be referred to as a PROCESS.
[ISO 14971:2019, definition 3.14]
3.98
RECORD
Add the following NOTES and replace the existing source statement for definition, modified by
Amendment 1, with:
NOTE 1 RECORDS can be used, for example, to formalize traceability and to prov
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.