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ISO 22442-3:2007

Medical devices utilizing animal tissues and their derivatives — Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
27. 11. 2007.

Опште информације

90.92     29. 10. 2024.

ISO

ISO/TC 194

Međunarodni standard

11.100.20  

engleski   francuski   ruski  

Kupovina

Objavljen

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Apstrakt

ISO 22442-3:2007 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.

Životni ciklus

TRENUTNO

OBJAVLJEN
ISO 22442-3:2007
90.92 Odluka o izmeni ili reviziji standarda
29. 10. 2024.

REVIDIRAN OD

PROJEKAT
ISO/AWI 22442-3

Nacionalna preuzimanja

SRPS EN ISO 22442-3:2011  
ISS

Medicinska sredstva za koja se upotrebljavaju životinjska tkiva i njihovi derivati – Deo 3: Validacija eliminacije i/ili inaktivacije virusa i agensa transmisione spongioformne encefalopatije (TSE)

60.60   Standard objavljen

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