ISO 11607-2:2006 Preview

Packaging for terminally sterilized medical devices -- Part 2: Validation requirements for forming, sealing and assembly processes

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

  • Current status : Published
    Publication date : 2006-04
  • Edition : 1
    Number of pages : 11
  • :
    ISO/TC 198
    Sterilization of health care products
  • 11.080.30
    Sterilized packaging

Buy this standard

Format Language
PDF
Paper
  • CHF58

Got a question?

Check out our FAQs


Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)

Life cycle

A standard is reviewed every 5 years



Revisions / Corrigenda