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About This Item

 

Full Description

BS EN ISO 11607-1:2009 specifies the 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.

BS EN ISO 11607-1:2009 is applicable to industry, to health care facilities, and wherever medical devices are placed in sterile barrier systems and sterilized.

BS EN ISO 11607-1:2009 does not cover all requirements for sterile barrier systems and packaging systems for medical devices that are manufactured aseptically. Additional requirements might also be necessary for drug/device combinations.

BS EN ISO 11607-1:2009 does not describe a quality assurance system for control of all stages of manufacture.



Cross References:
ISO 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


All current amendments available at time of purchase are included with the purchase of this document.
 

Document History

  1. BS EN ISO 11607-1:2020+A11:2022


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

    • Most Recent
  2. BS EN ISO 11607-1:2020


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

    • Historical Version
  3. BS EN ISO 11607-1:2020 Draft


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

    • Historical Version
  4. BS EN ISO 11607-1:2017 - TC


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

    • Historical Version
  5. BS EN ISO 11607-1:2017


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

    • Historical Version
  6. BS EN ISO 11607-1:2009+A1:2014


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

    • Historical Version
  7. BS EN ISO 11607-1:2009

    👀currently
    viewing


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

    • Historical Version
  8. BS EN ISO 11607-1:2006


    Packaging for terminally sterilized medical devices

    • Historical Version
  9. BS EN 868-1:1997


    Packaging materials and systems for medical devices which are to be sterilized. General requirements and test methods

    • Historical Version