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)

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 Steril-barrieresysteme, Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität der in der Endverpackung zu sterilisierenden Medizinprodukte bis zum Anwendungszeitpunkt aufrecht¬zuerhalten.
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 Verpackungs-systeme für aseptisch hergestellte Medizinprodukte. Für Kombinationen von Arzneimitteln und Medizin-produkten 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, y compris Amd 1:2014)

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)

ISO 11607-1:2006 podaja zahteve in preskusne metode za materiale, izvedene sterilne pregradne sisteme, sterilne pregradne sisteme in sisteme embalaže, ki so namenjeni za vzdrževanje sterilnosti končno steriliziranih medicinskih pripomočkov do njihove uporabe.
ISO 11607-1:2006 se uporablja za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so sterilizirani v sterilnih pregradnih sistemih.
ISO 11607-1:2006 ne zajema vseh zahtev za sterilne pregradne sisteme in sisteme embalaže medicinskih pripomočkov, ki so izdelani aseptično. Za kombinacije zdravil/pripomočkov so morda potrebne dodatne zahteve.
ISO 11607-1:2006 ne opisuje sistema zagotavljanja kakovosti za nadzor vseh faz proizvodnje.

General Information

• Status: Withdrawn
• Publication Date: 18-Jul-2017
• Withdrawal Date: 14-Jan-2020
• 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: 15-Jan-2020
• 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
• Ref Project: SIST 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)

Relations

• Replaces: 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)
• Effective Date: 08-Jun-2022
• Replaces: 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: 28-Jun-2017
• Replaced By: EN ISO 11607-1:2020 - Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
• Effective Date: 21-Jan-2020

Standards Content (Sample)

SLOVENSKI STANDARD
SIST EN ISO 11607-1:2017
01-september-2017
1DGRPHãþD
SIST EN ISO 11607-1:2009
SIST EN ISO 11607-1:2009/A1:2014
(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 11607-1:2017
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2017 en
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.

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SIST EN ISO 11607-1:2017

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SIST EN ISO 11607-1:2017


EN ISO 11607-1
EUROPEAN STANDARD

NORME EUROPÉENNE

July 2017
EUROPÄISCHE NORM
ICS 11.080.30 Supersedes EN ISO 11607-1:2009
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
terminal - Partie 1: Exigences relatives aux matériaux, sterilisierende Medizinprodukte - Teil 1:
aux systèmes de barrière stérile et aux systèmes Anforderungen an Materialien, Sterilbarrieresysteme
d'emballage (ISO 11607-1:2006) und Verpackungssysteme (ISO 11607-1:2006)
This European Standard was approved by CEN on 18 July 2017.

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, Former Yugoslav Republic of Macedonia, France, Germany, Greece, Hungary, Iceland, Ireland, Italy, Latvia, Lithuania,
Luxembourg, Malta, Netherlands, Norway, Poland, Portugal, 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: Avenue Marnix 17, B-1000 Brussels
© 2017 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2017 E
worldwide for CEN national Members.

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SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)
Contents Page
European foreword . 3
Annex ZA (informative) Relationship between this European Standard and the essential
requirements of Directive 93/42/EEC [OJ L 169] aimed to be covered . 5
Annex ZB (informative) Relationship between this European Standard and the essential
requirements of Directive 90/385/EEC [OJ L 189] aimed to be covered . 7
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] aimed to be covered . 9

2

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SIST EN ISO 11607-1:2017
EN ISO 11607-1:2017 (E)
European 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 11607-1:2017 by 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 January 2018, and conflicting national
...