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

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BS EN ISO 11607-1:2009

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

Status : Current   Published : February 2010

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What is BS EN ISO 11607-1:2009?

BS EN ISO 11607-1 sets out the requirements and test methods for materials, preformed sterile barrier systems and packaging that should keep medical equipment and instruments sterilised up until they are used. This standard applies to industry and healthcare facilities where medical devices are placed in sterile barrier systems and sterilised. BS EN ISO 11607-1 doesn’t cover all the requirements for packaging materials that are manufactured aseptically. Users might need to look at additional requirements for drug or device combinations.

How does it work?

BS EN ISO 11607-1 looks at quality systems, including sampling, test methods and documentation. The standard also defines the different materials and preformed sterile barrier systems, before focussing on microbial barrier properties. It also explains compatibility with the sterilisation process and labelling system, as well as design and stability testing.

Who should buy it?

  • Designers of packaging materials for sterilised medical equipment
  • Industrial designers
  • Quality assurers
  • Regulatory bodies

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Standard NumberBS EN ISO 11607-1:2009
TitlePackaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
StatusCurrent
Publication Date28 February 2010
Cross ReferencesISO 5636-5:2003, ASTM F1980:2002, ISO 5636-3:1992, ASTM D737:2004, ISO 536:1995, ASTM D4321:1999, ASTM D3776:1996, ISO 2758:2001, TAPPI T 437-OM-96, ISO 9197:1998, ASTM F2217:2002, ISO 187:1990, ASTM D4332:2001, ISO 2233:2000, ASTM F2203:2002, ISO 9073-9:1995, ISO 2493:1992, DIN 53121:1978, ASTM F392:1999, ASTM F2228:2002, ASTM F1929:1998, ASTM F2227:2002, ASTM F2096:2002, IST 80-8, ASTM F1608:2000, DIN 58953-6:1987, BS 6256:1989, ASTM F2101:2001, SS 8760019, ASTM D4169:2001, ISTA 1, 2, and 3, ISO 4180-1:1980, ISO 6588-1:2005, ISO 6588-2:2005, ASTM F2338:2003, ASTM F2250:2003, ASTM F2252:2003, ASTM D1709:2001, ASTM F1306:1998, ASTM D3420:2002, ASTM F88:2000, ASTM F1140:2000, ASTM F2054:2000, BS 6524:1989, ISO 9198:2001, ASTM D1922:2000, ASTM D1938:2002, ISO 1974:1990, ISO 1924-2:1994, ASTM D882:2002, ISO 534:2005, ASTM D645:1997, ASTM F2251:2003, ASTM D3078:1994, ASTM F1886:1998, ISO 811:1981, EDANA 170-1-02, ASTM D779:2003, EN 20535:1994, ISO 3689:1983, ISO 3781:1983, ISO 186:2002, ISO 2859-1:1999, ISO 5636-1:1984, ISO 5636-2:1984, ISO 5636-5:2003, ISO 9001:2000, ISO 10993-1:2003, ISO 11135:1994, ISO 11137-1:2006, ISO 11137-2:2006, ISO 11137-3:2006, ISO/TS 11139:2006, ISO 11607-2:2006, ISO 13485:2003, ISO 13683:1997, ISO 14937:2000, ISO 17665-1, EN 285:1996, EN 550:1994, EN 552:1994, EN 554:1994, EN 868-1:1997, EN 868-2:1999, EN 868-3:1999, EN 868-4:1999, EN 868-5:1999, EN 868-6:1999, EN 868-7:1999, EN 868-8:1999, EN 868-9:2000, EN 868-10:2000, EN 1422:1997, EN 13795-1:2002, EN 14180:2003, ANSI/AAMI ST65:2000, VIM:1993, 93/42/EEC
ReplacesBS EN ISO 11607-1:2006
International RelationshipsEN ISO 11607-1:2009Identical, ISO 11607-1:2006 Identical
DescriptorsPackaging materials, Packaging, Medical equipment, Medical instruments, Sterilization (hygiene), Sterile equipment, Packages, Wrapping, Quality, Design, Performance, Compatibility, Seals, Test methods, Performance testing, Quality assurance systems
ICS11.080.30 (Sterilized packaging)
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
CommitteeLBI/35
ISBN978 0 580 66659 9
PublisherBSI
FormatA4
DeliveryYES
Pages34
File Size1.288 MB
Price£ 162.00


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