BS EN ISO 11607-2:2006+A1:2014 - Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes

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BS EN ISO 11607-2:2006+A1:2014

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

Status : Superseded, Withdrawn   Published : May 2006 Replaced By : BS EN ISO 11607-2:2017

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Standard NumberBS EN ISO 11607-2:2006+A1:2014
TitlePackaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
StatusSuperseded, Withdrawn
Publication Date31 May 2006
Withdrawn Date15 May 2018
Cross ReferencesISO 11607-1, ISO 186:2002, ISO 2859-1:1999, ISO 2859-1:1999/CORR1:2001, ISO 2859-1:1999/AMD1:2011, ISO 9001:2008, ISO 9001:2008/CORR1:2009, ISO/TS 11139:2006, ISO 13485:2003, ISO 13485:2003/CORR1:2009, ISO 9000:2005, EN 868-5:2009, EN 868-6:2009, EN 868-8:2009, EN 13795-1:2002+A1:2009, ANSI/AAMI ST65:2008, DIN 58953-7:2010, DIN 58953-8:2010, DIN 58953-9:2010, VIM:1993, 93/42/EEC
Replaced ByBS EN ISO 11607-2:2017
International RelationshipsISO 11607-2:2006/AMD 1:2014,EN ISO 11607-2 Amd 1 (07/14) I
Amended ByAmendment, September 2014
Draft Superseded By14/30255138 DC
DescriptorsPackaging processes, Verification, Performance testing, Acceptance (approval), Sealing processes, Sterile equipment, Medical equipment, Medical instruments, Packages, Quality assurance systems, Wrapping, Seals, Sterilization (hygiene), Packaging, Quality, Performance, Packaging materials
ICS11.080.30
Title in FrenchEmballages des dispositifs medicaux sterilises au stade terminal. Exigences de validation pour les procedes de formage, scellage et assemblage
Title in GermanVerpackungen fuer in der Endverpackung zu sterilisierende Medizinprodukte. Validierungsanforderungen Prozesse der Formgebung, Siegelung und des Zusammenstellens
CommitteeCH/198
ISBN978 0 580 77067 8
PublisherBSI
FormatA4
DeliveryYes
Pages20
File Size601 KB
Price£126.00


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