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in stockReleased: 2024-05-22
UNE EN ISO 11607-2:2020/A1:2024
Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes - Amendment 1: Application of risk management (ISO 11607-2:2019/Amd 1:2023)
Envasado para productos sanitarios esterilizados terminalmente. Parte 2: Requisitos de validación para procesos de conformación, sellado y ensamblado. Modificación 1: Aplicación de la gestión de riesgos. (ISO 11607-2:2019/Amd 1:2023).
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| Standard number: | UNE EN ISO 11607-2:2020/A1:2024 |
| Pages: | 24 |
| Released: | 2024-05-22 |
| Status: | Amendment |
| Pages (Spanish): | 23 |
DESCRIPTION
UNE EN ISO 11607-2:2020/A1:2024
Amendment 1 expands on the application of risk management throughout the phases of design and development, validation and production of the packaging system. Clause 1 Delete the following text from the scope: It is applicable to industry, to health care facilities, and to wherever medical devices are placed in sterile barrier systems and sterilized.