IEC 60601-1-11:2015/AMD1:2020

Amendment 1 - 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

Amendement 1 - Appareils électromédicaux - Partie 1-11 : 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 à domicile

General Information

• Status: Published
• Publication Date: 21-Jul-2020
• ICS: 01 - GENERALITIES. TERMINOLOGY. STANDARDIZATION. DOCUMENTATION
• ICS: 11.020.10 - Health care services in general
• ICS: 11.040.01 - Medical equipment in general
• Technical Committee: SC 62A - Common aspects of medical equipment, software, and systems
• Drafting Committee: JWG 6 - TC 62/SC 62A/JWG 6
• Current Stage: PPUB - Publication issued
• Start Date: 07-Aug-2020
• Completion Date: 22-Jul-2020

Relations

• Amends: 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
• Effective Date: 05-Sep-2023

Standards Content (Sample)

IEC 60601-1-11
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
AMENDMENT 1
AMENDEMENT 1
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

Appareils électromédicaux –
Partie 1-11: 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 à
domicile
IEC 60601-1-11:2015-01/AMD1:2020-07(en-fr)

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IEC 60601-1-11
Edition 2.0 2020-07
INTERNATIONAL
STANDARD
NORME
INTERNATIONALE
A MENDMENT 1
AM ENDEMENT 1
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

Appareils électromédicaux –
Partie 1-11: 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 à

domicile
INTERNATIONAL
ELECTROTECHNICAL
COMMISSION
COMMISSION
ELECTROTECHNIQUE
INTERNATIONALE
ICS 11.020.10; 11.040.01 ISBN 978-2-8322-8623-4

– 2 – IEC 60601-1-11:2015/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/1395/FDIS 62A/1410/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 15 P
members out of 15 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 second edition of IEC 60601-1-11 was published in 2015. Since the publication of
IEC 60601-1-11:2015, 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 third
edition of IEC 60601-1-11, which is presently targeted for publication sometime after 2024.
Those issues selected for inclusion on the final "short list" to be addressed in Amendment 1
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, four items were
presented to the National Committees present. All four items received the required 2/3 majority
of the National Committees present and voting and have been included in the "short list" for
consideration in preparing Amendment 1. All remaining issues have been placed on a "long list"
for consideration in the third edition of IEC 60601-1-11.
The "short list" of issues was documented in the design specification for Amendment 1. As
IEC 60601-1-11 was jointly developed with ISO/TC 121/SC 3, the work was assigned to
IEC/SC 62A-ISO/TC 121/SC 3 Joint Working Group (JWG) 6. JWG 6 was directed to consider
each issue described 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 IEC 60601-1-11:2015, the style in force at the time of
publication of IEC 60601-1-11 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 60601-1-11:2015/AMD1:2020
© IEC 2020
1.3.1 IEC 60601-1
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 60601-1-12, IEC 62366-1, ISO 7010 and ISO 15223-1 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/AMD2:2020
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
IEC 60601-1-12:2014/AMD1:2020
IEC 62366-1:2015, Medical devices – Part 1: Application of usability engineering to medical
devices
IEC 62366-1:2015/AMD1:2020
ISO 7010:2019, Graphical symbols – Safety colours and safety signs – Registered safety signs
ISO 15223-1:2016, Medical devices – Symbols to be used with medical device labels, labelling
and information to be supplied – Part 1: General requirements
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 and
IEC 60601-1:2005:AMD1:2012 + IEC 60601-1:2005/AMD2:2020, IEC 60601-1-2:2014 and
IEC 60601-1-2:2014/AMD1:2020, IEC 60601-1-6:2010 and IEC 60601-1-6:2010/AMD1:2013 +
IEC 60601-1-6:2010/AMD2:2020, IEC 60601-1-8:2006 and IEC 60601-1-8:2006/AMD1:2012 +
IEC 60601-1-8:2006/AMD2:2020, IEC 60601-1-12:2014 and
IEC 60601‑1‑12:2014/AMD1:2020, IEC 62366-1:2015 and IEC 62366-1:2015/AMD1:2020, and
the following definitions apply.

© IEC 2020
4.2.2 * Environmental conditions of transport and storage between uses
Replace, in the existing fourth paragraph, the reference "ISO 15223-1:2012" with
"ISO 15223-1:2016" in three places.
4.2.3.1 Continuous operating conditions
Replace, in the existing fourth paragraph, the reference "ISO 15223-1:2012" with
"ISO 15223-1:2016" in three places.
7.2 * Additional requirements for marking of IP classification
Replace the existing first paragraph with:
In addition to the requirements of 7.2.9 of the general standard, the ME EQUIPMENT or its parts
and, when appropriate, a carrying case shall be marked with the appropriate IP classification
as tested in 8.3.1.
If some or all of the protection against the ingress of water or particulate matter is provided by
a carrying case, then:
ENCLOSURE of the ME EQUIPMENT shall be marked with its degree of protection and SAFETY
a) the
SIGN ISO 7010-W001 (see IEC 60601-1:2005, Table D.2, SAFETY SIGN 2), as well as with
...