EN ISO 11607-1:2020/A11:2022
(Amendment)Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
This document specifies 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.
It does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.
It does not describe a quality assurance system for control of all stages of manufacture.
It does not apply to packaging materials and/or systems used to contain a contaminated medical device during transportation of the item to the site of reprocessing or disposal.
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1: Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO 11607-1:2019/A11:2020)
Dieses Dokument legt Anforderungen an und Prüfverfahren für Materialien, vorgefertigte Sterilbarrieresysteme, Sterilbarrieresysteme und Verpackungssysteme fest, die dazu vorgesehen sind, die Sterilität von in der Endverpackung sterilisierten Medizinprodukten bis zum Anwendungszeitpunkt zu erhalten.
Es gilt für die Industrie, für Einrichtungen des Gesundheitswesens und für alle anderen Einrichtungen, in denen Medizinprodukte in Sterilbarrieresysteme verpackt und sterilisiert werden.
Es erfasst nicht alle Anforderungen an Sterilbarrieresysteme und Verpackungssysteme für aseptisch hergestellte Medizinprodukte. Für Kombinationen von Medikamenten und Medizinprodukten können zusätzliche Anforderungen erforderlich sein.
Es beschreibt kein Qualitätssicherungssystem zur Lenkung aller Herstellungsschritte.
Es gilt nicht für Verpackungsmaterialien und/oder systeme, die dazu verwendet werden, ein verunreinigtes Medizinprodukt während des Transports zur Wiederaufbereitung oder Entsorgung aufzunehmen.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (ISO 11607-1:2019)
Le présent document 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 de façon terminale jusqu'au point d'utilisation.
Il s'applique à l'industrie, aux établissements de santé et à tout lieu où des dispositifs médicaux sont insérés dans des systèmes de barrière stérile et stérilisés.
Il 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 peuvent être nécessaires pour garantir les combinaisons médicaments/dispositifs.
Il ne décrit pas de système d'assurance qualité pour le contrôle de toutes les étapes de fabrication.
Il ne s'applique pas aux matériaux d'emballage et/ou systèmes utilisés pour contenir un dispositif médical contaminé pendant le transport du dispositif vers le site de retraitement ou d'élimination.
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A11 (ISO 11607-1:2019)
Ta dokument določa 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. Uporablja se za industrijo, zdravstvene ustanove in vse medicinske pripomočke, ki so sterilizirani v sterilnih pregradnih sistemih. 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. Ne opisuje sistema zagotavljanja kakovosti za nadzor vseh faz proizvodnje. Ne uporablja se za embalažo in/ali sisteme, ki se uporabljajo za hrambo kontaminiranega medicinskega pripomočka med prevozom elementa na mesto predelave ali odstranjevanja.
General Information
Relations
Standards Content (Sample)
SLOVENSKI STANDARD
SIST EN ISO 11607-1:2020/A11:2022
01-september-2022
Embalaža za končno sterilizirane medicinske pripomočke - 1. del: Zahteve za
materiale, sterilne pregradne sisteme in sisteme embalaže - Dopolnilo A11 (ISO
11607-1:2019)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Verpackungen für in der Endverpackung zu sterilisierende Medizinprodukte - Teil 1:
Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme (ISO
11607-1:2019/A11:2020)
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials,
sterile barrier systems and packaging systems (ISO 11607-1:2019)
Ta slovenski standard je istoveten z: EN ISO 11607-1:2020/A11:2022
ICS:
11.080.30 Sterilizirana embalaža Sterilized packaging
SIST EN ISO 11607-1:2020/A11:2022 en,fr,de
2003-01.Slovenski inštitut za standardizacijo. Razmnoževanje celote ali delov tega standarda ni dovoljeno.
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SIST EN ISO 11607-1:2020/A11:2022
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SIST EN ISO 11607-1:2020/A11:2022
EN ISO 11607-
EUROPEAN STANDARD
1:2020/A11
NORME EUROPÉENNE
EUROPÄISCHE NORM
June 2022
ICS 11.080.30
English Version
Packaging for terminally sterilized medical devices - Part
1: Requirements for materials, sterile barrier systems and
packaging systems (ISO 11607-1:2019)
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 11607-1:2019) und Verpackungssysteme (ISO 11607-1:2019)
This amendment A11 modifies the European Standard EN ISO 11607-1:2020; it was approved by CEN on 13 April 2022.
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, 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
© 2022 CEN All rights of exploitation in any form and by any means reserved Ref. No. EN ISO 11607-1:2020/A11:2022 E
worldwide for CEN national Members.
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SIST EN ISO 11607-1:2020/A11:2022
EN ISO 11607-1:2020/A11:2022 (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] (as amended) 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] (as amended) aimed to be covered . 8
Annex ZC (informative) Relationship between this European Standard and the essential
requirements of Directive 98/79/EC [OJ L 331] (as amended) aimed to be covered . 10
2
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SIST EN ISO 11607-1:2020/A11:2022
EN ISO 11607-1:2020/A11:2022 (E)
European foreword
This document (EN ISO 11607-1:2020/A11:2022) has been prepared by Technical Committee CEN/TC
102 “Sterilizers and associated equipment for processing of medical devices”, the secretariat of which is
held by DIN.
This Amendment to the European Standard EN ISO 11607-1:2020 shall be given the status of a national
standard, either by publication of an identical text or by endorsement, at the latest by December 2022,
and conflicting national standards shall be withdrawn at the latest by December 2022.
Attention is drawn to the possibility that some of the elements of this documen
...
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