Name:
ISO 11607-2:2019 PDF
Published Date:
02/01/2019
Status:
Active
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.
| Edition : | 2nd |
| File Size : | 1 file , 1.1 MB |
| Note : | This product is unavailable in Ukraine, Russia, Belarus |
| Number of Pages : | 20 |
| Published : | 02/01/2019 |
| Same As : | ISO 11607-2:2019 |
