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

Standard No.
BS EN ISO 11607-1:2009+A1:2014
Release Date
2014
Published By
SCC
Status
Replace By
BS EN ISO 11607-1:2017
Latest
BS EN ISO 11607-1:2020+A1:2023
Scope
Cross References: iso 5636-5 ASTM F1980:2002 ISO 5636-3:1992 ASO 536:1995 ASTM D376:1996 ISO 2758:2 97:1998 ASTM F2 :2002 iso 187:1990 Astm d4332:2000 Astm F2203:2002 Iso 9073-9:1995 Din 53121:1978 Astm F22228:202 F1929:1998 ASTM F2227:2002 ASTM F2 :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 6588-1:1. 2005 ISO 6588-2:2005 ASTM F2338:2003 ASTM F2252:2003 ASTM F1709:2001 ASTM D3420:2002 ASTM F1140:2000 ASTM 2054:2000 bs 6524:1989 i i 9198:2001 Astm D1922:2000 ASTM D1938:2002 ISO 1974:1990 ISO 1924-2:2002 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 i 3689:1983 i i i 186:2002 i 2859-1:1999 iso 5636-2:1984 iso 9001: 2008 iso 10993- 1:2009 iso 11137-1:2006 iso 11137-2:2006 iso/s 11139:2006 iso 13485:2003 iso 17665- iso 1:2006 en 285+A2:2009 EN 868-2:1999 EN 868-3:2009 EN 868-4:1999 EN 868-5:2009 EN 868-6:2009 EN 868-7:2009 EN 868-8:1999 EN 868-2009 EN 868-8:1999 EN 868-8:1999 9:2000 EN 868-10:2000 EN 1422:1997 EN 13795-1+A1:2009 EN 14180+A2:2009 ANSI/AAMI ST65:2008 93/42/EEC Incorporates the following: Amendment, August 2014. Amends and replaces BS EN ISO 11607-1:2009

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

  • 2023 BS EN ISO 11607-1:2020+A1:2023 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • 1970 BS EN ISO 11607-1:2020+A11:2022 Packaging for terminally sterilized medical devices. Validation requirements for forming, sealing and assembly processes
  • 1970 BS EN ISO 11607-1:2020 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • 1970 BS EN ISO 11607-1:2017 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • 2014 BS EN ISO 11607-1:2009+A1:2014 Packaging for terminally sterilized medical devices-Requirements for materials, sterile barrier systems and packaging systems
  • 2010 BS EN ISO 11607-1:2010 Packaging for terminally sterilized medical devices. Requirements for materials, sterile barrier systems and packaging systems
  • 2010 BS EN ISO 11607-1:2009 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • 2006 BS EN ISO 11607-1:2006 Packaging for terminally sterilized medical devices - Requirements for materials, sterile barrier systems and packaging systems
  • 1997 BS EN 868-1:1997 Packaging materials and systems for medical devices which are to be sterilized - General requirements and test methods



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