EN ISO 11607-1:2009

Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

ISO 11607-1:2006 specifies the requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use.
ISO 11607-1:2006 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.
ISO 11607-1:2006 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.
ISO 11607-1:2006 does not describe a quality assurance system for control of all stages of manufacture.

Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2006)

Dieser Teil von ISO 11607 legt die Anforderungen und Prüfverfahren für Materialien, vorgefertigte Sterilbarrieresysteme,
Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität
der in der Endverpackung zu sterilisierenden Medizinprodukte bis zum Anwendungszeitpunkt aufrechtzuerhalten.
Dieser Teil von ISO 11607 gilt für die Industrie, für Gesundheitseinrichtungen und alle anderen Einrichtungen,
in denen Medizinprodukte in Sterilbarrieresysteme verpackt und sterilisiert werden.
Dieser Teil von ISO 11607 erfasst nicht alle Anforderungen an Sterilbarrieresysteme und Verpackungssysteme
für aseptisch hergestellte Medizinprodukte. Für Kombinationen von Arzneimitteln und Medizinprodukten
können auch zusätzliche Anforderungen erforderlich sein.
Dieser Teil von ISO 11607 beschreibt kein Qualitätssicherungssystem zur Lenkung aller Herstellungsschritte.

Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage (ISO 11607-1:2006)

L'ISO 11607-1:2006 spécifie les exigences et les méthodes d'essai pour les matériaux, les systèmes de barrière stérile préformés, les systèmes de barrière stérile et les systèmes d'emballage destinés à maintenir l'état de stérilité des dispositifs médicaux stérilisés au stade terminal jusqu'au point d'utilisation.
L'ISO 11607-1:2006 s'applique à l'industrie, aux installations de santé et à tout lieu où les dispositifs médicaux se trouvent dans des systèmes de barrière stérile et stérilisés.
L'ISO 11607-1:2006 ne couvre pas toutes les exigences relatives aux systèmes de barrière stérile et systèmes d'emballage pour les dispositifs médicaux fabriqués de manière aseptique. Dans ce cas, des exigences supplémentaires sont nécessaires pour garantir les combinaisons médicaments/dispositifs.
L'ISO 11607-1:2006 ne décrit pas de système d'assurance qualité pour le contrôle de toutes les étapes de fabrication.

Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže (ISO 11607-1:2006)

General Information

• Status: Withdrawn
• Publication Date: 02-Jun-2009
• 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
• Mandate: M/023 - Standardization mandate to CEN/CENELEC concerning the development of European standards relating to medical devices
• Mandate: M/BC/CEN/88/9 - Order for standardization concerning Personal Protective Equipment (P.P.E.) - foot and leg protection
• Ref Project: SIST EN ISO 11607-1:2009 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)

Relations

• Replaces: EN ISO 11607-1:2006 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006)
• Effective Date: 22-Dec-2008
• Replaced By: EN ISO 11607-1:2017 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006, including Amd 1:2014)
• Effective Date: 08-Jun-2022
• Amended By: EN ISO 11607-1:2009/A1:2014 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2006/Amd 1:2014)
• Effective Date: 08-Jun-2022

Standards Content (Sample)

SLOVENSKI STANDARD
01-september-2009
1DGRPHãþD
SIST EN ISO 11607-1:2006
(PEDODåD]DNRQþQRVWHULOL]LUDQHPHGLFLQVNHSULSRPRþNHGHO=DKWHYH]D
PDWHULDOHVWHULOQHSUHJUDGQHVLVWHPHLQVLVWHPHHPEDODåH,62
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2006)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2006)
Emballages des dispositifs médicaux stérilisés au stade terminal - Partie 1: Exigences
relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
(ISO 11607-1:2006)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2009
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 11607-1
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2009
ICS 11.080.30 Supersedes EN ISO 11607-1:2006
English Version
Packaging for terminally sterilized medical devices - Part 1:
Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2006)
Emballages des dispositifs médicaux stérilisés au stade Verpackungen für in der Endverpackung zu sterilisierende
terminal - Partie 1: Exigences relatives aux matériaux, aux Medizinprodukte - Teil 1: Anforderungen an Materialien,
systèmes de barrière stérile et aux systèmes d'emballage Sterilbarrieresysteme und Verpackungssysteme (ISO
(ISO 11607-1:2006) 11607-1:2006)
This European Standard was approved by CEN on 16 May 2009.
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 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 Management Centre has the same status as the
official versions.
CEN members are the national standards bodies of Austria, Belgium, Bulgaria, Cyprus, Czech Republic, Denmark, Estonia, Finland,
France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal,
Romania, Slovakia, Slovenia, Spain, Sweden, Switzerland and United Kingdom.
EUROPEAN COMMITTEE FOR STANDARDIZATION
COMITÉ EUROPÉEN DE NORMALISATION
EUROPÄISCHES KOMITEE FÜR NORMUNG
Management Centre: Avenue Marnix 17, B-1000 Brussels
© 2009 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2009: 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 .4

Foreword
The text of ISO 11607-1:2006 has been prepared by Technical Committee ISO/TC 198 “Sterilization of health
care products” of the International Organization for Standardization (ISO) and has been taken over as EN ISO
11607-1:2009 by Technical Committee CEN/TC 102 “Sterilizers for medical purposes” 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 December 2009, and conflicting national standards shall be withdrawn
at the latest by March 2010.
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 supersedes EN ISO 11607-1:2006.
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 EC Directive.
For relationship with EC Directive, 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, Cyprus, Czech
Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia,
Lithuania, Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, Romania, Slovakia, Slovenia, Spain,
Sweden, Switzerland and the United Kingdom.
Endorsement notice
The text of ISO 11607-1:2006 has been approved by CEN as a EN ISO 11607-1:2009 without any
modification.
Annex ZA
(informative)
Relationship between this European Standard and the Essential Requirements of
EU Directive 93/42/EEC
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 Communities 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 European Standard and Directive 93/42/EEC
Clause(s)/Sub-clause(s) of Essential Requirements Qualifying remarks/Notes
this International Standard (ERs) of EU Directive
93/42/EEC
4.1, 4.2 1, 2
4.3, 4.4, 4.5 3, 4, 5, 6
5.1.1 to 5.1.11 7.1, 7.3, 7.5, 7.6
5.1.9 9.1, 9.2
5.2 8.1
5.3 8.3, 8.6
5.4 8.6
5.5 5, 8.3
6.1 1,2, 6
6.2 3, 7.1, 7.3, 7.5, 7.6, 8.3, 8.6,
13.1, 13.5
6.3 8.1, 8.6
6.4 5
7 13 The applicable parts of the Essential
Requirement 13 are partly addressed
13.3 a) This relevant Essential Requirement is not
addressed in this European Standard
13.3 f) This relevant Essential Requirement is not
addressed in this European Standard
13.6 h) This relevant Essential Requirement is not
addressed in this European Standard
13.6 (q) This relevant Essential Requirement is not
addressed in this European Standard
WARNING: Other requirements and other EU Directives may be applicable to the product(s) falling within the
scope of this standard.
INTERNATIONAL ISO
STANDARD 11607-1
First edition
2006-04-15
Packaging for terminally sterilized
medical devices —
Part 1:
Requirements for materials, sterile barrier
systems and packaging systems
Emballages des dispositifs médicaux stérilisés au stade terminal —
Partie 1: Exigences relatives aux matériaux, aux systèmes de barrière
stérile et aux systèmes d'emballage

Reference number
ISO 11607-1:2006(E)
©
ISO 2006
ISO 11607-1:2006(E)
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ISO 11607-1:2006(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 General. 5
4.2 Quality systems . 5
4.3 Sampling. 6
4.4 Test methods. 6
4.5 Documentation. 6
5 Materials and preformed sterile barrier systems . 7
5.1 General requirements. 7
5.2 Microbial barrier properties . 9
5.3 Compatibility with the sterilization process. 10
5.4 Compatibility with the labelling system . 10
5.5 Storage and transport . 10
6 Design and development requirements for packaging systems . 11
6.1 General. 11
6.2 Design . 11
6.3 Packaging-system performance testing. 12
6.4 Stability testing . 12
7 Information to be provided . 13
Annex A (informative) Guidance on medical packaging. 14
Annex B (informative) Standardized test methods and procedures that may be used to
demonstrate compliance with the requirements of this part of ISO 11607 . 17
Annex C (normative) Test method for resistance of impermeable materials to the passage of air. 21
Bibliography . 22

ISO 11607-1:2006(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International S
...