prEN ISO 11197
(Main)Medical supply units (ISO/DIS 11197:2024)
Medical supply units (ISO/DIS 11197:2024)
IEC 60601-1:2005+A1:2012, 1.1 is replaced by:
This document applies to the basic safety and essential performance of medical supply units, hereafter also referred to as ME equipment.
This document applies to medical supply units manufactured within a factory or assembled on site, including cabinetry and other enclosures, which incorporate patient care services.
NOTE 1 A party that assembles on site various components intended for patient care services into an enclosure is considered the manufacturer of the medical supply unit.
Hazards inherent in the intended function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this standard, except in of IEC 60601-1:2005+A1:2012, 7.2.13 and 8.4.1 (see 201.1.4).
NOTE 2 Refer to IEC 60601-1:2005+A1:2012, 4.2.
Medizinische Versorgungseinheiten (ISO/DIS 11197:2024)
Gaines techniques à usage médical (ISO/DIS 11197:2024)
Le paragraphe 1.1 de l'IEC 60601-1:2005+A1:2012 est remplacé par:
Le présent document s'applique à la sécurité de base et aux performances essentielles des gaines techniques à usage médical, également désignées sous le terme d'appareil EM.
Le présent document s'applique aux gaines techniques à usage médical fabriquées en usine ou montées sur site, y compris les armoires et autres enveloppes, qui intègrent des services de soins aux patients.
NOTE 1 Une entité qui monte sur site divers composants destinés à des services de soins aux patients pour constituer une enveloppe est considérée comme le fabricant de la gaine technique à usage médical.
Les dangers inhérents à la fonction prévue de l'appareil EM ou des systèmes EM dans le cadre du domaine d'application du présent document ne sont pas couverts par des exigences spécifiques contenues dans la présente norme, à l'exception des paragraphes 7.2.13 et 8.4.1 de l'IEC 60601‑1:2005+A1:2012, (voir 201.1.4).
NOTE 2 Voir le paragraphe 4.2 de l'IEC 60601-1:2005+A1:2012.
Enote za oskrbo v medicini (ISO/DIS 11197:2024)
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Standards Content (Sample)
SLOVENSKI STANDARD
01-junij-2024
Enote za oskrbo v medicini (ISO/DIS 11197:2024)
Medical supply units (ISO/DIS 11197:2024)
Medizinische Versorgungseinheiten (ISO/DIS 11197:2024)
Gaines techniques à usage médical (ISO/DIS 11197:2024)
Ta slovenski standard je istoveten z: prEN ISO 11197
ICS:
11.040.01 Medicinska oprema na Medical equipment in general
splošno
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
DRAFT
International
Standard
ISO/DIS 11197
ISO/TC 121/SC 6
Medical supply units
Secretariat: ANSI
Gaines techniques à usage médical
Voting begins on:
2024-03-26
ICS: 11.040.01
Voting terminates on:
2024-06-18
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
BE CONSIDERED IN THE LIGHT OF THEIR
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
Reference number
ISO/DIS 11197:2024(en)
DRAFT
ISO/DIS 11197:2024(en)
International
Standard
ISO/DIS 11197
ISO/TC 121/SC 6
Medical supply units
Secretariat: ANSI
Gaines techniques à usage médical
Voting begins on:
ICS: 11.040.01
Voting terminates on:
THIS DOCUMENT IS A DRAFT CIRCULATED
FOR COMMENTS AND APPROVAL. IT
IS THEREFORE SUBJECT TO CHANGE
AND MAY NOT BE REFERRED TO AS AN
INTERNATIONAL STANDARD UNTIL
PUBLISHED AS SUCH.
This document is circulated as received from the committee secretariat.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL,
© ISO 2024
TECHNOLOGICAL, COMMERCIAL AND
USER PURPOSES, DRAFT INTERNATIONAL
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
STANDARDS MAY ON OCCASION HAVE TO
ISO/CEN PARALLEL PROCESSING
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
BE CONSIDERED IN THE LIGHT OF THEIR
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
ISO copyright office
RECIPIENTS OF THIS DRAFT ARE INVITED
CP 401 • Ch. de Blandonnet 8
TO SUBMIT, WITH THEIR COMMENTS,
CH-1214 Vernier, Geneva
NOTIFICATION OF ANY RELEVANT PATENT
Phone: +41 22 749 01 11
RIGHTS OF WHICH THEY ARE AWARE AND TO
PROVIDE SUPPORTING DOCUMENTATION.
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/DIS 11197:2024(en)
ii
ISO/DIS 11197:2024(en)
Contents Page
Foreword . iv
Introduction . v
201.1 Scope, object and related standards . 1
201.1.1 Scope . 1
201.1.2 Object . 1
201.1.3 Related standards . 1
201.1.3.1 General and Collateral standards . 1
201.1.3.2 Particular standards . 2
201.2 Normative references . 2
201.3 Terms and definitions . 3
201.4 General requirements . 5
201.5 General requirements for testing ME equipment . 5
201.6 Classification of ME equipment and ME systems . 5
201.7 ME equipment identification, marking and documents . 6
201.8 Protection against electrical hazards from ME equipment . 10
201.9 Protection against mechanical hazards of ME equipment and ME systems . 17
201.10 Protection against unwanted and excessive radiation hazards . 20
201.11 Protection against excessive temperatures and other hazards . 20
201.12 Accuracy of controls and instruments and protection against hazardous outputs . 21
201.13 Hazardous situations and fault conditions . 21
201.13.2.2 Single fault conditions . 21
201.14 Programmable electrical medical systems (PEMS) . 22
201.15 Construction of ME equipment . 22
201.16 ME systems . 27
201.17 Electromagnetic compatibility of ME equipment and ME systems . 27
202 Medical electrical equipment — Parts 1-2 General requirements for basic safety and
essential performance — Collateral standard: Electromagnetic disturbances — Requirements
and tests . 27
206 Medical electrical equipment — Parts 1-6 General requirements for basic safety and
essential performance — Collateral standard: Usability. 27
Annex A A (informative) Rationale . 28
Annex B B (informative) Tests during production . 29
Annex C C (informative) Documentation . 33
Annex D D (informative) Terminology — Alphabetical index of defined terms . 34
Bibliography . 36
iii
ISO/DIS 11197:2024(en)
Foreword
ISO (the International Organization for Standardization) is a worldwide federation of national
standards bodies (ISO member bodies). The work of preparing International Standards is normally
carried out through ISO technical committees. Each member body interested in a subject for which a
technical committee has been established has the right to be represented on that committee.
International organizations, governmental and non-governmental, in liaison with ISO, also take part in
the work. ISO collaborates closely with the International Electrotechnical Commission (IEC) on all
matters of electrotechnical standardization.
The procedures used to develop this document and those intended for its further maintenance are
described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the
different types of ISO documents should be noted. This document was drafted in accordance with the
editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of
any patent rights identified during the development of the document will be in the Introduction and/or
on the ISO list of patent declarations received (see www.iso.org/patents).
Any trade name used in this document is information given for the convenience of users and does not
constitute an endorsement.
For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and
expressions related to conformity assessment, as well as information about ISO's adherence to the
World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see
www.iso.org/iso/foreword.html.
This document was prepared by Technical Committee ISO/TC 121, Anaesthetic and respiratory
equipment, Subcommittee SC 6, Medical gas supply systems.
This fifth edition cancels and replaces the fourth edition (ISO 11197:2019), which has been technically
revised. The main changes compared to the previous edition are as follows:
— editorial revision;
— concerning the transition of temporary healthcare facilities to those which will become permanent
installations;
— inclusion in the requirements defining the use of anti-static hoses within medical supply units;
— inclusion of amendments following a scope gap assessment conducted against IEC 60601-
1:2005+A1:2012
Any feedback or questions on this document should be directed to the user’s national standards body. A
complete listing of these bodies can be found at www.iso.org/members.html.
iv
ISO/DIS 11197:2024(en)
Introduction
Many healthcare facilities use surface-mounted or recessed containment systems and enclosures for
accommodating and displaying essential patient care services. These are known as medical supply units.
This document specifies requirements for medical supply units manufactured in factories or assembled
from components on site.
It is intended for use by those persons involved in the design, construction, inspection, testing,
maintenance and operation of healthcare facilities as well as those manufacturing, assembling and
installing medical supply units.
Persons involved in the design, manufacture, installation, maintenance and testing of equipment
intended to be connected to gas for medicinal use, medical device gas, vacuum, anaesthetic gas
scavenging and/or plume extraction systems should be aware of the contents of this document.
This document is a particular standard, based on IEC 60601-1:2005+A1:2012. IEC 60601-
1:2005+A1:2012 is the basic standard for the safety of all medical electrical equipment used by or under
the supervision of qualified personnel in the general medical and patient environment; it also contains
certain requirements for reliable operation to ensure safety.
In order to fully understand this Particular Standard the reader is guided to read the Collateral Standard
IEC 60601-1:2005+A1:2012 in parallel.
IEC 60601-1:2005+A1:2012 has associated collateral standards and particular standards. The collateral
standards include requirements for specific technologies and/or hazards and apply to all applicable
equipment, such as medical systems, electromagnetic compatibility (EMC), radiation protection in
diagnostic X-ray equipment, software, etc. The particular standards apply to specific equipment types,
such as medical electron accelerators, high frequency surgical equipment, hospital beds, etc.
Where a healthcare facility is developed for temporary use, such as in a pandemic or other natural
disaster, the basic principles of this standard shall apply. Once the stage of critical use of the facility has
normalised the product remaining in use shall fulfil the requirements of this standard.
NOTE Definitions of collateral standard and particular standard can be found in IEC 60601:2005+A1:2012.
For an explanation of the special numbering in this document and more on the terms “collateral”,
“particular” and “general” standards, see 201.1.3, 201.1.3.1, 201.1.3.2.
Annex AA contains rationale statements for some of the requirements of this document. It is included to
provide additional insight into the reasoning that led to the requirements and recommendations that
have been incorporated in this document. The clauses and subclauses marked with (*) after their
number have a corresponding rationale contained in Annex AA.
In this document, the following print types are used:
— requirements, compliance with which can be verified, and definitions: roman type;
— informative material appearing outside of tables, such as notes, examples and references: in smaller
roman type. Normative text of tables is also in a smaller roman type;
— test methods: italic type;
— terms defined in clause 3 of the general standard, in this document or as noted: italic type.
v
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