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

General Information

Status
Published
Publication Date
20-Sep-2020
Current Stage
5060 - Close of voting Proof returned by Secretariat
Start Date
20-Jun-2020
Completion Date
19-Jun-2020
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IEC 60601-1-11:2015/FDAmd 1
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FINAL
IEC
AMENDMENT
DRAFT
60601-1-11:2015
FDAM 1
ISO/TC 121/SC 3
Medical electrical equipment —
Secretariat: ANSI
Voting begins on:
Part 1-11:
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
home healthcare environment
AMENDMENT 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
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 60601-1-11:2015/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
---------------------- Page: 1 ----------------------
– 2 – IEC FDIS 60601-1-11:2015/AMD1
© 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.

_____________
---------------------- Page: 2 ----------------------
IEC FDIS 60601-1-11:2015/AMD1 – 3 –
© 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.
---------------------- Page: 3 ----------------------
– 4 – IEC FDIS 60601-1-11:2015/AMD1
© 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.
---------------------- Page: 4 ----------------------
IEC FDIS 60601-1-11:2015/AMD1 – 5 –
© 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
...

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