Back

ISO 11607-2:2006

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

General information
Withdrawn from 31.01.2019
Directives or regulations
None
Standard history
Status
Date
Type
Name
31.01.2019
Main
07.07.2014
Amendment
07.04.2006
Main
Main
ISO 11607:2003
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.
*
*
*
PDF
64.44 € incl tax
Paper
64.44 € incl tax
Standard monitoring