BS EN ISO 11607-1:2009+A1:2014 - Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

BS EN ISO 11607-1:2009+A1:2014

Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems

Status : Superseded, Withdrawn   Published : February 2010 Replaced By : BS EN ISO 11607-1:2017

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Standard NumberBS EN ISO 11607-1:2009+A1:2014
TitlePackaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
StatusSuperseded, Withdrawn
Publication Date28 February 2010
Withdrawn Date15 May 2018
Normative References(Required to achieve compliance to this standard)ISO 5636-5
Informative References(Provided for Information)ISO 186:2002, ASTM F1886:1998, ASTM D3078:1994, DIN 58953-6:1987, ISO 9000:2005, ISO 11137-1:2006, ISO 5636-1:1984, ASTM D3420:2002, ISO 11137-3:2006, ISO 10993-1:2009, ISO 4180-1:1980, ASTM F2096:2002, ISO 6588-2:2005, EN 285+A2:2009, ISO/TS 11139:2006, ISO 11607-2:2006, ASTM F1140:2000, ASTM D4169:2001, ISO 534:2005, ISO 11137-2:2006, ISO 9001:2008, ASTM D1922:2000, ASTM D645:1997, ISO 2233:2000, ISO 811:1981, ISO 6588-1:2005, ISO 2758:2001, EN 20535:1994, ISO 9198:2001, ISTA 1, 2, and 3, ASTM F88:2000, EN 13795-1+A1:2009, ASTM D779:2003, ASTM D882:2002, ASTM F2251:2003, ASTM F2101:2001, ASTM F2228:2002, SS 8760019, ISO 3781:1983, DIN 53121:1978, EDANA 170-1-02, ISO 14937:2000, ASTM F1306:1998, ASTM D4321:1999, ASTM D1709:2001, ISO 5636-2:1984, ASTM F1608:2000, TAPPI T 437-OM-96, ASTM F2227:2002, ISO 9073-9:1995, ISO 9197:1998, EN 868-2:1999, ANSI/AAMI ST65:2008, EN 868-9:2000, EN 868-4:1999, EN 868-3:2009, ISO 536:1995, BS 6256:1989, EN 868-8:1999, EN 1422:1997, ISO 2493:1992, EN 868-5:2009, ISO 1924-2:1994, EN 868-6:2009, ISO 187:1990, ISO 5636-3:1992
Replaced ByBS EN ISO 11607-1:2017
ReplacesBS EN ISO 11607-1:2006
International RelationshipsEN ISO 11607-1:2009/A1:2014,ISO 11607-1:2006/Amd 1:2014
Amended ByAmendment, August 2014
Draft Superseded By14/30255135 DC
DescriptorsDesign, Wrapping, Packages, Compatibility, Seals, Medical equipment, Performance testing, Sterilization (hygiene), Test methods, Packaging, Medical instruments, Quality assurance systems, Packaging materials, Quality, Sterile equipment, Performance
ICS11.080.30
Title in FrenchEmballages des dispositifs médicaux stérilisés au stade terminal. Exigences relatives aux matériaux, aux systèmes de barrière stérile et aux systèmes d'emballage
Title in GermanVerpackungen für in der Endverpackung zu sterilisierende Medizinprodukte. Anforderungen an Materialien, Sterilbarrieresysteme und Verpackungssysteme
CommitteeCH/198
ISBN978 0 580 77066 1
PublisherBSI
FormatA4
DeliveryYes
Pages40
File Size1.238 MB
Price£218.00


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