IEC 60601-1-12:2014/Amd 1:2020

FINAL
IEC
AMENDMENT
DRAFT
60601-1-12:2014
FDAM 1
ISO/TC 121/SC 3
Medical Electrical Equipment —
Secretariat: ANSI
Voting begins on:
Part 1-12:
2020-04-24
General requirements for basic
Voting terminates on:
safety and essential performance -
2020-06-19
Collateral Standard: Requirements
for medical electrical equipment
and medical electrical systems used
in the emergency medical services
environment
AMENDMENT 1
Appareils électromédicaux —
Partie 1-12: Exigences générales pour la sécurité de base et les
performances essentielles — Norme collatérale: Exigences pour les
appareils électromédicaux et les systèmes électromédicaux utilisés
dans l'environnement des soins d'urgence
AMENDEMENT 1
This draft is submitted to a parallel vote in ISO and in IEC.
RECIPIENTS OF THIS DRAFT ARE INVITED TO
SUBMIT, WITH THEIR COMMENTS, NOTIFICATION
OF ANY RELEVANT PATENT RIGHTS OF WHICH
THEY ARE AWARE AND TO PROVIDE SUPPOR TING
DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
IEC 60601-1-12:2014/FDAM 1:2020(E)
LOGICAL, COMMERCIAL AND USER PURPOSES,
DRAFT INTERNATIONAL STANDARDS MAY ON
OCCASION HAVE TO BE CONSIDERED IN THE
LIGHT OF THEIR POTENTIAL TO BECOME STAN-
DARDS TO WHICH REFERENCE MAY BE MADE IN
©
NATIONAL REGULATIONS. IEC 2020

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© 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, and ISO subcommittee 3: Respiratory devices and related equipment used
for patient care of ISO technical committee 121: Anaesthetic and respiratory equipment.
It is published as a double logo amendment.
The text of this amendment is based on the following documents of IEC:
FDIS Report on voting
62A/XXX/FDIS 62A/XXX/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. In ISO, the amendment has been approved by XXX P
members out of YYY having cast a vote.
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• withdrawn,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 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.

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IEC FDIS 60601-1-12:2014/AMD1 – 3 –
© IEC 2020
INTRODUCTION TO AMENDMENT 1
The first edition of IEC 60601-1-12 was published in 2014. Since the publication of
IEC 60601-1-12:2014, the IEC Subcommittee (SC) 62A Secretariat has been collecting issues
from a variety of sources including comments from National Committees. 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 an amendment and should not wait until the
second edition of IEC 60601-1-12, which is presently targeted for publication sometime after
2024.
As directed in item 1 of Kobe Resolution 1, the IEC/SC 62A Chairman Advisory Group (CAG)
considered the 27 issues collected by the SC/62A Secretariat for IEC 60601-1-12:2014 and
determined that none met the selection criteria stated in Kobe Resolution 1.
However, an amendment is needed to update the references to IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020. In London in 2018,
SC 62A approved the development of an administrative amendment to IEC 60601-1-12:2014.
Because this is an amendment to IEC 60601-1-12:2014, the style in force at the time of
publication of IEC 60601-1-12 has been applied to this amendment. The 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.
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.

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