PRICES include / exclude VAT
Not available online - contact us!
immediate downloadReleased: 2020-01-20
BS EN ISO 11607-2:2020
Packaging for terminally sterilized medical devices Validation requirements for forming, sealing and assembly processes
CURRENCY
| Standard number: | BS EN ISO 11607-2:2020 |
| Pages: | 24 |
| Released: | 2020-01-20 |
| ISBN: | 978 0 539 03838 5 |
| Status: | Standard |
DESCRIPTION
BS EN ISO 11607-2:2020
This standard BS EN ISO 11607-2:2020 Packaging for terminally sterilized medical devices is classified in these ICS categories:
- 11.080.30 Sterilized packaging
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.