EN ISO 11607-2:2006/A1:2014

Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)

2013-10-08 GVN: Draft for // vote received in ISO/CS (see notification of 2013-10-08 in dataservice).
2013-01-09 EMA: Draft for // ENQ received in ISO/CS (see notification of 2013-01-08 in dataservice).
2012-02-14 EMA: WI allocated to WG 4 as per TC secretary request.

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)

N/A

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)

Embalaža za končno sterilizirane medicinske pripomočke - 2. del: Zahteve validacije za proces oblikovanja, označevanja in sestavljanja (ISO 11607-2:2006/Amd 1:2014)

Ti procesi vključujejo oblikovanje, označevanje in sestavljanje izvedenih sterilnih pregradnih sistemov, sterilnih pregradnih sistemov in sistemov embalaže. Ta del standarda ISO 11607 velja za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so dani v embalažo in sterilizirani. Ta del standarda ISO 11607 ne zajema vseh zahtev za embalažo medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so lahko potrebne dodatne zahteve.

General Information

• Status: Withdrawn
• Publication Date: 15-Jul-2014
• Withdrawal Date: 18-Jul-2017
• ICS: 11.080.30 - Sterilized packaging
• Technical Committee: CEN/TC 102 - Sterilizers for medical purposes
• Drafting Committee: CEN/TC 102/WG 4 - Packaging materials
• Current Stage: 9960 - Withdrawal effective - Withdrawal
• Completion Date: 19-Jul-2017
• Directive: 2007/47/EC - Directive 2007/47/EC of the European Parliament and of the council of 5 September 2007 amending Council Directive 90/385/EEC on the approximation of the laws of the Member States relating to active implantable medical devices, Council Directive 93/42/EEC concerning medical devices and Directive 98/8/EC concerning the placing of biocidal products on the market
• Directive: 90/385/EEC - Council Directive 90/385/EEC of 20 June 1990 on the approximation of the laws of the Member States relating to active implantable medical devices
• Directive: 93/42/EEC - Council Directive 93/42/EEC of 14 June 1993 concerning medical devices
• Directive: 98/79/EC - Directive 98/79/EC of the European Parliament and of the Council of 27 October 1998 on in vitro diagnostic medical devices
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Ref Project: SIST EN ISO 11607-2:2006/A1:2014 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006/Amd 1:2014)

Relations

• Replaced By: EN ISO 11607-2:2017 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006, including Amd 1:2014)
• Effective Date: 28-Jun-2017
• Amends: EN ISO 11607-2:2006 - Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2006)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11607-2:2006/oprA1:2013
01-maj-2013
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO=DKWHYH
YDOLGDFLMH]DSURFHVREOLNRYDQMDR]QDþHYDQMDLQVHVWDYOMDQMD'RSROQLOR,62
'$0
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for
forming, sealing and assembly processes - Amendment 1 (ISO 11607-2:2006/DAM
1:2013)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 2:
Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des
Zusammenstellens - Änderung 1 (ISO 11607-2:2006/DAM 1:2013)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 2: Exigences de
validation pour les procédés de formage, scellage et assemblage - Amendement 1 (ISO
11607-2:2006/DAM 1:2013)
Ta slovenski standard je istoveten z: EN ISO 11607-2:2006/prA1
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-2:2006/oprA1:2013 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

SIST EN ISO 11607-2:2006/oprA1:2013

SIST EN ISO 11607-2:2006/oprA1:2013

EUROPEAN STANDARD
DRAFT
EN ISO 11607-2:2006
NORME EUROPÉENNE
EUROPÄISCHE NORM
prA1
March 2013
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part 2:
Validation requirements for forming, sealing and assembly
processes - Amendment 1 (ISO 11607-2:2006/DAM 1:2013)
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 - Prozesse der Formgebung, Siegelung und des
Amendement 1 (ISO 11607-2:2006/DAM 1:2013) Zusammenstellens - Änderung 1 (ISO 11607-2:2006/DAM
1:2013)
This draft amendment is submitted to CEN members for parallel enquiry. It has been drawn up by the Technical Committee CEN/TC 102.

This draft amendment A1, if approved, will modify the European Standard EN ISO 11607-2:2006. If this draft becomes an amendment,
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.

This draft amendment was established by CEN 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.
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.

Warning : This document is not a European Standard. It is distributed for review and comments. It is subject to change without notice and
shall not be referred to as a European Standard.

EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION

EUROPÄISCHES KOMITEE FÜR NORMUNG

Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2013 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-2:2006/prA1:2013: E
worldwide for CEN national Members.

SIST EN ISO 11607-2:2006/oprA1:2013
EN ISO 11607-2:2006/prA1:2013 (E)
Contents
Page
Foreword . 3

SIST EN ISO 11607-2:2006/oprA1:2013
EN ISO 11607-2:2006/prA1:2013 (E)
Foreword
This document (EN ISO 11607-2:2006/prA1:2013) 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 document is currently submitted to the parallel Enquiry.
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).
Endorsement notice
The text of ISO 11607-2:2006/DAM 1:2013 has been approved by CEN as EN ISO 11607-2:2006/prA1:2013
without any modification.
SIST EN ISO 11607-2:2006/oprA1:2013

SIST EN ISO 11607-2:2006/oprA1:2013

DRAFT AMENDMENT ISO 11607-2:2006/DAM 1
ISO/TC 198 Secretariat: ANSI
Voting begins on Voting terminates on

2013-03-14 2013-08-14
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION  •  МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ  •  ORGANISATION INTERNATIONALE DE NORMALISATION

Packaging for terminally sterilized medical devices —
Part 2:
Validation requirements for forming, sealing and assembly
processes
AMENDMENT 1
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage
AMENDEMENT 1
ICS 11.080.30
ISO/CEN PARALLEL PROCESSING
This draft has been developed within the International Organization for Standardization (ISO), and
processed under the ISO-lead mode of collaboration as defined in the Vienna Agreement.
This draft is hereby submitted to the ISO member bodies and to the CEN member bodies for a parallel
five-month enquiry.
Should this draft be accepted, a final draft, established on the basis of comments received, will be
submitted to a parallel two-month approval vote in ISO and formal vote in CEN.

To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.

THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO 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.
©  International Organization for Standardization, 2013

SIST EN ISO 11607-2:2006/oprA1:2013
ISO 11607-2:2006/DAM 1
Copyright notice
This ISO document is a Draft International Standard and is copyright-prot
...

SLOVENSKI STANDARD
01-oktober-2014
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO=DKWHYH
YDOLGDFLMH]DSURFHVREOLNRYDQMDR]QDþHYDQMDLQVHVWDYOMDQMD,62
$PG
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
...