Reference number
ISO 11607-2:2006
© ISO 2024
ISO 11607-2:2006
Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
Edition 1
2006-04
Withdrawn
Withdrawn (Edition 1, 2006)

Abstract

ISO 11607-2:2006 specifies the requirements for development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing, and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems.

ISO 11607-2:2006 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized.

ISO 11607-2:2006 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.

General information

  • Status
     : Withdrawn
    Publication date
     : 2006-04
    Stage
    : Withdrawal of International Standard [95.99]
  • Edition
     : 1
    Number of pages
     : 11
  • Technical Committee :
    ISO/TC 198
    ICS :
    11.080.30 
  • RSS updates

Life cycle

Got a question?

Check out our Help and Support

  2. Store
  3. Standards catalogue
  4. ICS
  5. 11
  6. 11.080
  7. 11.080.30
  8. ISO 11607-2:2006