SIST EN ISO 11608-1:2022/oprA1:2025

SLOVENSKI STANDARD
01-september-2025
Peresa za injiciranje za uporabo v medicini - Zahteve in preskusne metode - 1. del:
Peresa za injiciranje - Dopolnilo A1 (ISO 11608-1:2022/DAmd1:2025)
Needle-based injection systems for medical use - Requirements and test methods - Part
1: Needle-based injection systems - Amendment 1 (ISO 11608-1:2022/DAmd1:2025)
Kanülenbasierte Injektionssysteme zur medizinischen Verwendung - Anforderungen und
Prüfverfahren - Teil 1: Kanülenbasierte Injektionssysteme - Änderung 1 (ISO 11608
1:2022/DAmd 1:2025)
Systèmes d'injection à aiguille pour usage médical - Exigences et méthodes d'essai -
Partie 1: Systèmes d'injection à aiguille - Amendement 1 (ISO 11608-
1:2025/DAmd1:2025)
Ta slovenski standard je istoveten z: EN ISO 11608-1:2022/prA1:2025
ICS:
11.040.25 Injekcijske brizge, igle in Syringes, needles an
katetri catheters
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

DRAFT
Amendment
ISO 11608-1:2022/
DAM 1
ISO/TC 84
Needle-based injection systems for
Secretariat: DS
medical use — Requirements and
test methods —
Voting begins on:
2025-07-29
Part 1:
Voting terminates on:
Needle-based injection systems 2025-10-21
AMENDMENT 1
Systèmes d'injection à aiguille pour usage médical — Exigences
et méthodes d'essai —
Partie 1: Systèmes d'injection à aiguille
AMENDEMENT 1
ICS: 11.040.25
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.
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NOTIFICATION OF ANY RELEVANT PATENT
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PROVIDE SUPPORTING DOCUMENTATION.
Reference number
ISO 11608-1:2022/DAM 1:2025(en)

DRAFT
ISO 11608-1:2022/DAM 1:2025(en)
Amendment
ISO 11608-1:2022/
DAM 1
ISO/TC 84
Needle-based injection systems for
Secretariat: DS
medical use — Requirements and
test methods —
Voting begins on:
Part 1:
Voting terminates on:
Needle-based injection systems
AMENDMENT 1
Systèmes d'injection à aiguille pour usage médical — Exigences
et méthodes d'essai —
Partie 1: Systèmes d'injection à aiguille
AMENDEMENT 1
ICS: 11.040.25
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 2025
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
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POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN
or ISO’s member body in the country of the requester.
NATIONAL REGULATIONS.
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Published in Switzerland Reference number
ISO 11608-1:2022/DAM 1:2025(en)

ii
ISO 11608-1:2022/DAM 1:2025(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).
ISO draws attention to the possibility that the implementation of this document may involve the use of (a)
patent(s). ISO takes no position concerning the evidence, validity or applicability of any claimed patent
rights in respect thereof. As of the date of publication of this document, ISO had not received notice of (a)
patent(s) which may be required to implement this document. However, implementers are cautioned that
this may not represent the latest information, which may be obtained from the patent database available at
www.iso.org/patents. ISO shall not be held responsible for identifying any or all such patent rights.
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 84, Devices for administration of medicinal
products and catheters.
This amendment addresses editorial inconsistencies with regards to terminology introduced in the
last revision, e.g. use of "anticipated/normal conditions" vs. "in-use conditions" and interchangeable and
inconsistent use of "conditioning" and "preconditioning".
In addition, it tries to improve subclause 10.2 with regards to the sequence of visual inspection and
assessment of primary functions.
It does not introduce new requirements, and it does not change existing requirements.
A list of all parts in the ISO 11608 series can be found on the ISO website.
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.

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