UNE EN ISO 11607-2:2020
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes (ISO 11607-2:2019)
Envasado para productos sanitarios esterilizados terminalmente. Parte 2: Requisitos de validación para procesos de conformación, sellado y ensamblado. (ISO 11607-2:2019).
| Označení normy: | UNE EN ISO 11607-2:2020 |
| Počet stran: | 22 |
| Vydáno: | 2020-09-23 |
| Status: | Norma |
UNE EN ISO 11607-2:2020
This part of ISO 11607 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. This part of ISO 11607 is applicable to industry, to health care facilities, and wherever medical devices are packaged and sterilized. This part of ISO 11607 does not cover all requirements for packaging medical devices that are manufactured aseptically. Additional requirements may also be necessary for drug/device combinations.