BS EN ISO 11607-2:2017 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

BS EN ISO 11607-2:2017

Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

Status : Superseded, Withdrawn   Published : May 2018 Replaced By : BS EN ISO 11607-2:2020

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What is this standard about?

This part of ISO 11607 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

Who is this standard for?

This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.



Standard NumberBS EN ISO 11607-2:2017
TitlePackaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
StatusSuperseded, Withdrawn
Publication Date15 May 2018
Withdrawn Date20 January 2020
Normative References(Required to achieve compliance to this standard)ISO 11607-1:2018, ISO 11607-1
Informative References(Provided for Information)ISO 14971, ISO 2859-1, ANSI/AAMI ST90, ISO 11607-2, EN 13795-1, EN 868-8, ISO 9001, ANSI/AAMI ST65, GAMP 5, ISO 186, ISO 11607-1, DIN 58953-7, DIN 58953-8, ANSI/AAMI ST77, DIN 58953-9, ISO/TS 16775, DIN 58953-8:2003 (G), ISO 13485:2003, DIN 58953-7:2003 (G), ISO/TS 11139:2006, DIN 58953-9:2000 (G), EN 868-8:1999, ISO 9001:2000, ISO 2859-1:1999, EN 868-6:1999, ISO 186:2002, ISO 13485:2016, EN 868-5:1999, ISO 9000:2000, ISO 11139:2018, EN 13795-1:2002
Replaced ByBS EN ISO 11607-2:2020
International RelationshipsEN ISO 11607-2:2017,ISO 11607-2:2006,ISO 11607-2:2019
Draft Superseded By17/30351720 DC
DescriptorsSealing processes, Packaging, Packaging processes, Acceptance (approval), Sterile equipment, Performance testing, Seals, Verification, Packaging materials, Sterilization (hygiene), Packages, Medical equipment, Medical instruments, Wrapping, Performance, Quality assurance systems, Quality
ICS11.080.30
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal Partie 2: Exigences de validation pour les procédés de formage, scellage et assemblage
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte Validierungsanforderungen an Prozesse der Formgebung, Siegelung und des Zusammenstellens
CommitteeCH/198
ISBN978 0 580 96434 3
PublisherBSI
FormatA4
DeliveryYes
Pages26
File Size655 KB
Price£182.00


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