EN ISO 11607-2:2006/A1:2014

SLOVENSKI STANDARD
01-oktober-2014
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Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte — Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens (ISO 11607-2:2006/Amd 1:2014)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage (ISO 11607-
2:2006/Amd 1:2014)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2006/A1:2014
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

EUROPEAN STANDARD
EN ISO 11607-2:2006/A1
NORME EUROPÉENNE
EUROPÄISCHE NORM
July 2014
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part 2:
Validation requirements for forming, sealing and assembly
processes (ISO 11607-2:2006/Amd 1:2014)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu sterilisierende
terminal - Partie 2: Exigences de validation pour les Medizinprodukte - Teil 2: Validierungsanforderungen an
procédés de formage, scellage et assemblage (ISO 11607- Prozesse der Formgebung, Siegelung und des
2:2006/Amd 1:2014) Zusammenstellens (ISO 11607-2:2006/Amd 1:2014)
This amendment A1 modifies the European Standard EN ISO 11607-2:2006; it was approved by CEN on 14 June 2014.

CEN members are bound to comply with the CEN/CENELEC Internal Regulations which stipulate the conditions for inclusion of this
amendment into the relevant 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 amendment 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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, 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: Avenue Marnix 17, B-1000 Brussels
© 2014 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2006/A1:2014 E
worldwide for CEN national Members.

Contents Page
Foreword .3
Annex ZA (informative) Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices .4

Foreword
This document (EN ISO 11607-2:2006/A1:2014) has been prepared by Technical Committee ISO/TC 198
“Sterilization of health care products” in collaboration with Technical Committee CEN/TC 102 “Sterilizers for
medical purposes” the secretariat of which is held by DIN.
This Amendment to the European Standard EN ISO 11607:2006 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by January 2015, and
conflicting national standards shall be withdrawn at the latest by January 2015.
Attention is drawn to the possibility that some of the elements of this document may be the subject of patent
rights. CEN [and/or CENELEC] shall not be held responsible for identifying any or all such patent rights.
This document has been prepared under a mandate given to CEN by the European Commission and the
European Free Trade Association, and supports essential requirements of EU Directive(s).
For relationship with EU Directive(s), see informative Annex ZA, which is an integral part of this document.
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, Former Yugoslav Republic of Macedonia, France, Germany, Greece,
Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland, Turkey and the United Kingdom.
Endorsement notice
The text of ISO 11607-2:2006/Amd 1:2014 has been approved by CEN as EN ISO 11607-2:2006/A1:2014
without any modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential
Requirements of EU Directive 93/42/EEC on medical devices
This European Standard has been prepared under a mandate given to CEN by the European Commission
and the European Free Trade Association to provide a means of conforming to Essential Requirements of the
New Approach Directive 93/42/EEC on medical devices.
Once this standard is cited in the Official Journal of the European Union under that Directive and has been
implemented as a national standard in at least one Member State, compliance with the clauses of this
standard given in Table ZA.1 confers, within the limits of the scope of this standard, a presumption of
conformity with the corresponding Essential Requirements of that Directive and associated EFTA regulations.
Table ZA.1 — Correspondence between this International Standard and Directive 93/42/EEC on
medical device
Clause(s)/subclause(s) Essential Qualifying remarks/notes
of this International Requirements (ERs)
standard of EU Directive
93/42/EEC
4.1, 4.3, 5, 6, 7, 8 7.6 Partly addressed.
To fully address the ER, requirements for materials, sterile
barrier systems and packaging systems need to be
addressed (ISO 11607-1).
4.1, 4.3, 5, 6
...