EN ISO 11607-2:2020

SLOVENSKI STANDARD
01-marec-2020
Nadomešča:
SIST EN ISO 11607-2:2017
Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve za
validacijo pri procesih oblikovanja, označevanja in sestavljanja (ISO 11607-2:2019)
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607-2:2019)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-2:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2020
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EN ISO 11607-2
EUROPEAN STANDARD
NORME EUROPÉENNE
January 2020
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-2:2017
English Version
Packaging for terminally sterilized medical devices - Part
2: Validation requirements for forming, sealing and
assembly processes (ISO 11607-2:2019)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu
terminal - Partie 2: Exigences de validation pour les sterilisierende Medizinprodukte - Teil 2:
procédés de formage, scellage et assemblage (ISO Validierungsanforderungen an Prozesse der
11607-2:2019) Formgebung, Siegelung und des Zusammenstellens
(ISO 11607-2:2019)
This European Standard was approved by CEN on 4 December 2019.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for giving this
European Standard the status of a national standard without any alteration. Up-to-date lists and bibliographical references
concerning such national standards may be obtained on application to the CEN-CENELEC Management Centre or to any CEN
member.
This European Standard exists in three official versions (English, French, German). A version in any other language made by
translation under the responsibility of a CEN member into its own language and notified to the CEN-CENELEC Management
Centre has the same status as the official versions.

CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Croatia, Cyprus, Czech Republic, Denmark, Estonia,
Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway,
Poland, Portugal, Republic of North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and
United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

CEN-CENELEC Management Centre: Rue de la Science 23, B-1040 Brussels
© 2020 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2020 E
worldwide for CEN national Members.

Contents Page
European foreword . 3

European foreword
This document (EN ISO 11607-2:2020) has been prepared by Technical Committee ISO/TC 198
"Sterilization of health care products" in collaboration with Technical Committee CEN/TC 102
“Sterilizers and associated equipment for processing of medical devices” the secretariat of which is held
by DIN.
This European Standard shall be given the status of a national standard, either by publication of an
identical text or by endorsement, at the latest by July 2020, and conflicting national standards shall be
withdrawn at the latest by July 2020.
Attention is drawn to the possibility that some of the elements of this document may be the subject of
patent rights. CEN shall not be held responsible for identifying any or all such patent rights.
This document supersedes EN ISO 11607-2:2017.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association.
According to the CEN-CENELEC Internal Regulations, the national standards organizations of the
following countries are bound to implement this European Standard: Austria, Belgium, Bulgaria,
Croatia, Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland,
Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Republic of
North Macedonia, Romania, Serbia, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the
United Kingdom.
Endorsement notice
The text of ISO 11607-2:2019 has been approved by CEN as EN ISO 11607-2:2020 without any
modification.
INTERNATIONAL ISO
STANDARD 11607-2
Second edition
2019-02
Packaging for terminally sterilized
medical devices —
Part 2:
Validation requirements for forming,
sealing and assembly processes
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 2: Exigences de validation pour les procédés de formage,
scellage et assemblage
Reference number
ISO 11607-2:2019(E)
©
ISO 2019
ISO 11607-2:2019(E)
© ISO 2019
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting
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Email: copyright@iso.org
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Published in Switzerland
ii © ISO 2019 – All rights reserved

ISO 11607-2:2019(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 General requirements . 5
4.1 Quality systems . 5
4.2 Risk management . 6
4.3 Sampling . 6
4.4 Test methods . 6
4.5 Documentation . 6
5 Validation of packaging processes . 7
5.1 General . 7
5.2 Installation qualification . 7
5.3 Operational qualification . 8
5.4 Performance qualification . 9
5.5 Formal approval of the process validation. 9
5.6 Process control and monitoring .10
5.7 Process changes and revalidation .10
6 Assembly .10
7 Use of reusable sterile barrier systems .11
8 Sterile fluid-path packaging .11
Annex A (informative) Process development .12
Bibliography .13
ISO 11607-2:2019(E)
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 the following
URL: www .iso .org/iso/foreword .html.
This document was prepared by Technical Committee ISO/TC 198, Sterilization of health care products.
This second edition cancels and replaces the first edition (ISO 11607-2:2006), which has been technically
revised. It also incorporates the amendment ISO 11607-2:2006/Amd.1:2014.
The main changes compared to the previous edition are as follows:
— terms and definitions for “process variable”, “process parameter” and “monitoring of processes”
have been added;
— various definitions have been aligned with the latest version of ISO 11139;
— the terminology of “critical” process parameters has been discontinued and the concept of a process
specification has been introduced to include all elements required to manufacture a product that
consistently meets specifications.
A list of all parts in the ISO 11607 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.
iv © ISO 2019 – All rights reserved

ISO 11607-2:2019(E)
Introduction
Packaging for termi
...