IEC 60601-1:2005/AMD1:2012

IEC 60601-1 ®
Edition 3.0 2012-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 1: General requirements for basic safety and essential performance

Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances
essentielles
IEC 60601-1:2005/A1:2012
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IEC 60601-1 ®
Edition 3.0 2012-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
colour
inside
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –

Part 1: General requirements for basic safety and essential performance

Appareils électromédicaux –
Partie 1: Exigences générales pour la sécurité de base et les performances

essentielles
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
PRICE CODE
INTERNATIONALE
CODE PRIX XE
ICS 11.040 ISBN 978-2-83220-227-2

– 2 – 60601-1 Amend.1 © IEC:2012
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/805/FDIS 62A/820/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• withdrawn,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.
The contents of the corrigendum of July 2014 have been included in this copy.
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.
_____________
60601-1 Amend.1 © IEC:2012 – 3 –
INTRODUCTION TO THE AMENDMENT
The third edition of IEC 60601-1 was published in 2005. At the time of publication, there were
nd
94 National Committee comments on the 2 CDV and the FDIS that were deferred to a future
amendment/revision. Each of their deferred comments was captured in an Issue Sheet by the
SC 62A secretariat. By the time of the Auckland meeting in April 2008, the Subcommittees
had developed two Interpretation Sheets and the SC 62A secretariat has received an
additional 15 issues from National Committees and other interested parties.
st
At the Auckland meeting, IEC/TC 62 approved a project to develop the 1 amendment to
IEC 60601-1:2005 based on the issues outstanding at the time. The TC approved developing
st
the 1 amendment with a view to addressing outstanding issues, including but not limited to:
– those listed in 62A/593/DC and 62A/602/INF;
– 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.
Since the Auckland meeting, the secretariat has received 73 additional issues from National
Committees or other interested parties for a total of 182 Issues Sheets. This amendment is
intended to address those issues.

– 4 – 60601-1 Amend.1 © IEC:2012
FOREWORD
Replace the paragraph beginning "This third edition cancels…" with the following:
This third edition cancels and replaces the second edition published in 1988, its Amendment 1
(1991) and Amendment 2 (1995), the second edition of IEC 60601-1-1 published in 2000 and
the first edition of IEC 60601-1-4 published in 1996 and its Amendment 1 (1999). This edition
constitutes a technical revision. This edition has been significantly restructured. Requirements
in the electrical section have been further aligned with those for information technology
equipment covered by IEC 60950-1 and a requirement for including a RISK MANAGEMENT
PROCESS has been added. For an expanded description of this revision, see Annex A.3.
Add the following note at the end of the Foreword:
NOTE The attention of National Committees 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.
INTRODUCTION
In the second dash of the existing ninth paragraph, replace the final sentence with:
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).
After the last paragraph of the introduction, insert the following new paragraph:
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 Scope, object and related standards
1.1 * Scope
Renumber the note as Note 1.
Delete the fourth paragraph.
Replace the fifth paragraph with:
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.

60601-1 Amend.1 © IEC:2012 – 5 –
1.3 * Collateral standards
Replace Note 3 with:
NOTE 3 Collateral standards in the IEC 60601 family are numbered IEC 60601-1-xx. The IEC maintains a
catalogue of valid International Standards. Users of this standard should consult this catalogue at
"http://webstore.iec.ch" to determine which collateral standards have been published.
1.4 * Particular standards
Replace the note with:
NOTE 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.
2 * Normative references
Update the following normative references:
)
IEC 60065:2001, Audio, video and similar electronic apparatus – Safety requirements
Amendment 1:2005
Amendment 2:2010
IEC 60068-2-2:2007, Environmental testing – Part 2-2: Tests – Test B: Dry heat
IEC 60227-1:2007, Polyvinyl chloride insulated cables of rated voltages up to and including
450/750 V – Part 1: General requirements
IEC 60245-1:2003, Rubber insulated cables – Rated voltages up to and including 450/750 V –
Part 1: General requirements
Amendment 1:2007
IEC 60335-1:2010, Household and similar electrical appliances – Safety – Part 1: General
requirements
IEC 60417, Graphical symbols for use on equipment. Available from:
symbols.info/equipment>
IEC 60601-1-3, Medical electrical equipment – Part 1-3: General requirements for basic safety
and essential performance: Collateral standard: Radiation protection in diagnostic X-ray
equipment
IEC 60664-1:2007, Insulation coordination for equipment within low-voltage systems – Part 1:

Principles, requirements and tests
IEC 60730-1:2010, Automatic electrical controls for household and similar use – Part 1:
General requirements
IEC 60825-1:2007, Safety of laser products – Part 1: Equipment classification and
requirements
___________
1)
There exists a consolidated edition 7.2 including IEC 60065:2001 and its Amendment 1 (2005) and
Amendment 2 (2010).
2)
There exists a consolidated edition 4.1 including IEC 60245-1:2003 and its Amendment 1 (2007).

– 6 – 60601-1 Amend.1 © IEC:2012
IEC 60851-3:2009, Winding wires – Test methods – Part 3: Mechanical properties
IEC 60851-5:2008, Winding wires – Test methods – Part 5: Electrical properties
)
IEC 61058-1:2000, Switches for appliances – Part 1: General requirements
Amendment 1:2001
Amendment 2:2007
ISO 7010:2011, Graphical symbols – Safety colours and safety signs –Registered safety signs
ISO 14971:2007, Medical devices – Application of risk management to medical devices
Replace the existing references to ISO 11135, ISO 11137, ISO 13852 and ISO 15223 by the
following:
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 – 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 the upper and lower limbs
ISO 15223-1:2012, Medical devices – Symbols to be used with medical device labels,
labelling and information to be supplied – Part 1: General requirements
Delete the following no
...