UNE-EN ISO 11607-1:2020/A1:2024
Current
The latest, up-to-date edition.
Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems - Amendment 1: Application of risk management (ISO 11607-1:2019/Amd 1:2023)
Hardcopy , PDF
English, Spanish, Castilian
22-05-2024
Amendment 1 expands on the application of risk management throughout the phases of design anddevelopment, validation and production of the packaging system.Clause 1Delete the following text from the scope: It is applicable to industry, to health care facilities, and towherever medical devices are placed in sterile barrier systems and sterilized.
| Committee |
CTN 111
|
| DocumentType |
Amendment
|
| Pages |
34
|
| PublisherName |
Asociación Española de Normalización
|
| Status |
Current
|
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