BS EN ISO 11607-2:2020
Withdrawn
A Withdrawn Standard is one, which is removed from sale, and its unique number can no longer be used. The Standard can be withdrawn and not replaced, or it can be withdrawn and replaced by a Standard with a different number.
Packaging for terminally sterilized medical devices Validation requirements for forming, sealing and assembly processes
Hardcopy , PDF
13-09-2022
English
20-01-2020
Important note : Users cannot be edited or removed once added to your Multi user PDF.| Committee |
CH/198
|
| DocumentType |
Standard
|
| ISBN |
9780539038385
|
| Pages |
24
|
| ProductNote |
THIS STANDARD ALSO REFERS TO :ISO 11607-1:2018
|
| PublisherName |
British Standards Institution
|
| Status |
Withdrawn
|
| Supersedes |
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.
| Standards | Relationship |
| EN ISO 11607-2:2020 | Identical |
| ISO 11607-2:2019 | Identical |
| EN ISO 11607-2:2017 | Identical |
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