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CEN

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)

General Information

Status
Not Published
Publication Date
21-Oct-2025
ICS
11.040.01 - Medical equipment in general
11.040.10 - Anaesthetic, respiratory and reanimation equipment
Technical Committee
CEN/TC 215 - Respiratory and anaesthetic equipment
Drafting Committee
CEN/TC 215/WG 3 - Medical gas supply systems
Current Stage
4020 - Submission to enquiry - Enquiry
Start Date
28-Mar-2024
Completion Date
28-Mar-2024
Directive
2017/745 - Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC
Mandate
M/565 - Medical devices and in vitro diagnostic medical devices in support of Regulation (EU) 2017/745 of the European Parliament and of the Council and Regulation (EU) 2017/746
Ref Project
oSIST prEN ISO 11197:2024 - Medical supply units (ISO/DIS 11197:2024)

Relations

Revises
EN ISO 11197:2019 - Medical supply units (ISO 11197:2019)
Effective Date
14-Jun-2023

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SLOVENSKI STANDARD
oSIST prEN ISO 11197:2024
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
oSIST prEN ISO 11197:2024 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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oSIST prEN ISO 11197:2024

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oSIST prEN ISO 11197:2024
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)
© ISO 2024

---------------------- Page: 3 ----------------------
oSIST prEN ISO 11197:2024
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.
COPYRIGHT PROTECTED DOCUMENT
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)
© ISO 2024
© ISO 2024 – All rights reserved
ii

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oSIST prEN ISO 11197:2024
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 refer
...

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