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ISO 11607-2:2019

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing and assembly processes
31. 1. 2019.

Опште информације

90.93     5. 7. 2024.

ISO

ISO/TC 198

Međunarodni standard

11.080.30  

engleski   francuski  

Kupovina

Objavljen

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Apstrakt

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.

Životni ciklus

PRETHODNO

POVUČEN
ISO 11607-2:2006

POVUČEN
ISO 11607-2:2006/Amd 1:2014

TRENUTNO

OBJAVLJEN
ISO 11607-2:2019
90.93 Odluka o potvrđivanju standarda
5. 7. 2024.

ISPRAVKE / IZMENE

OBJAVLJEN
ISO 11607-2:2019/Amd 1:2023

Nacionalna preuzimanja

SRPS EN ISO 11607-2:2020  
ISS

Ambalaža za terminalno sterilizovana medicinska sredstva - Deo 2: Validacija zahteva za procese oblikovanja, zatvaranja i sklapanja

60.60   Standard objavljen

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