EN
SR EN ISO 22442-3:2008
Dispozitive medicale utilizând ţesuturi animale şi derivatele lor. Partea 3: Validarea eliminării şi/sau inactivării viruşilor şi agenţilor encefalopatiei spongiforme transmisibile (TSE)
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.
Status :
In vigoare
Data aprobării : 27.05.2008
Data publicării : 29.05.2008
Număr de pagini : 33
ICS : 11.100.20 Evaluarea biologica a dispozitivelor medicale
Comitet tehnic : 377 - Medicale
- Inlocuieste SR EN 12442-3:2002