IEC 60601-1-12:2014/AMD1:2020

Amendment 1 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment

Amendement 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 destinés à être utilisés dans l'environnement des services médicaux d'urgence

General Information

• Status: Published
• Publication Date: 21-Jul-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 8 - TC 62/SC 62A/JWG 8
• Current Stage: PPUB - Publication issued
• Start Date: 07-Aug-2020
• Completion Date: 22-Jul-2020

Relations

• Amends: IEC 60601-1-12:2014 - Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-1-12
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
Medical electrical equipment –
Part 1-12: General requirements for basic safety and essential performance –
Collateral Standard: Requirements for medical electrical equipment and medical
electrical systems intended for use in the emergency medical services
environment
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 destinés à être utilisés dans l'environnement
des services médicaux d'urgence

IEC 60601-1-12:2014-06/AMD1:2020-07(en-fr)

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IEC 60601-1-12
Edition 1.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
Medical electrical equipment –

Part 1-12: General requirements for basic safety and essential performance –

Collateral Standard: Requirements for medical electrical equipment and medical

electrical systems intended for use in the emergency medical services

environment
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 destinés à être utilisés dans l'environnement

des services médicaux d'urgence

INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.040.01 ISBN 978-2-8322-8625-8

– 2 – IEC 60601-1-12:2014/AMD1:2020
© 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, 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/1396/FDIS 62A/1411/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 16 P
members out of 16 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.

_____________
© 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 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.
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 60601-1-12:2014/AMD1:2020
© IEC 2020
1.3.1 IEC 60601-1
Delete, in the existing first paragraph, the words "hereafter referred to as the general
standard".
Add, in the first two dashes of the existing second paragraph, the words ", including any
amendments".
2 Normative references
Replace the existing references to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6,
IEC 60601-1-8, IEC 60601-1-11 and ISO 7010 with the following new references:
IEC 60601-1:2005, Medical electrical equipment – Part 1: General requirements for basic
safety and essential performance
IEC 60601-1:2005/AMD1:2012
IEC 60601-1:2005/AMD2:2020
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
IEC 60601-1-2:2014/AMD1:2020
IEC 60601-1-6:2010, Medical electrical equipment – Part 1-6: General requirements for basic
safety and essential performance – Collateral standard: Usability
IEC 60601-1-6:2010/AMD1:2013
IEC 60601-1-6:2010/AMD2:2020
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
IEC 60601-1-8:2006/AMD1:2012
IEC 60601-1-8:2006/AMD1:2020
IEC 60601-1-11:2015, Medical electrical equipment – Part 1-11: General requirements for
basic safety and essential performance – Collateral Standard: Requirements for medical
electrical equipment and medical electrical systems used in the home healthcare environment
IEC 60601-1-11:2015/AMD1:2020
ISO 7010:2019, Graphical symbols – Safety colours and safety signs – Registered safety
signs
3 Terms and definitions
Replace the existing first paragraph with:
For the purposes of this document, the terms and definitions given in IEC 60601-1:2005,
IEC 60601-1:2005/AMD1:2012 and IEC 60601-1:2005/AMD2:2020, IEC 60601-1-6:2006,
IEC 60601-1-6:2006/AMD1:2013 and IEC 60601-1-6:2006/AMD2:2020, IEC 60601-1-8:2006,
IEC 60601-1-8:2006/AMD1:2012 and IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-11:2015
and IEC 60601-1-11:2015/AMD1:2020, and the following definitions apply.

© IEC 2020
Index of defined terms used in this collateral standard
Replace the following existing terms:
HAZARD. IEC 60601-1:2005/AMD1:2012/AMD2:2020, 3.39
HAZARDOUS SITUATION . IEC 60601-1:2005/AMD2:2020, 3.40
HOME HEALTHCARE ENVIRONMENT . IEC 60601-1-11:2015, 3.1
INTENDED USE . IEC 60601-1:2005/AMD2:2020, 3.44
LAY . IEC 60601-1-11:2015, 3.2
LOW PRIORITY . IEC 60601-1:2005/AMD2:2020, 3.151
MANUFACTURER . IEC 60601-1:2005/AMD2:2020, 3.55
MEDIUM PRIORITY . IEC 60601-1:2005/AMD2:2020 3.153
OPERATOR PROFILE . IEC 60601-1-6:2010/AMD2:2020, 3.2
PROCEDURE .IEC 60601-1:2005/AMD1:2012/AMD2:2020, 3.88
PROCESS . IEC 60601-1:2005/AMD2:2020, 3.89
RISK . IEC 60601-1:2005/AMD1:2012/AMD2:2020, 3.102
RISK ANALYSIS . IEC 606001-1:2005/AMD1:2012/AMD2:2020, 3.103
RISK CONTROL . IEC 60601-1:2005/AMD1:2012/AMD2:2020, 3.105
RISK MANAGEMENT . IEC 60601-1:2005/AMD2:2020, 3.107
RISK MANAGEMENT FILE . IEC 60601-:2005/AMD1:2012/AMD2:2020, 3.108
SHELF LIFE . IEC 60601-1-11:2015, 3.3
TRANSIT-O
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