Additional information
ICS Code | |
---|---|
ICS Name | |
Edition | |
Legal Status | |
Pages | |
Published Date | |
Replaced by | |
Replaces | |
Sector | |
Standard Development Stage | |
Standard Status | |
Technical Committee | |
Type of Standards |
P421.80
Packaging for terminally sterilized medical devices — Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
ICS Code | |
---|---|
ICS Name | |
Edition | |
Legal Status | |
Pages | |
Published Date | |
Replaced by | |
Replaces | |
Sector | |
Standard Development Stage | |
Standard Status | |
Technical Committee | |
Type of Standards |
This document specifies requirements for the 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. This document specifies requirements for the 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.
It is applicable to industry, to health care facilities, and to wherever medical devices are packaged and sterilized.
It does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements can be necessary for drug/device combinations.