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>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)
sklademVydáno: 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)

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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Označení normy:UNE EN ISO 11607-2:2020/A1:2024
Počet stran:24
Vydáno:2024-05-22
Status:Změna
Počet stran (Španělsky):23
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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.

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