Verkkokauppa
SFS-EN ISO 22442-3:en
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 (ISO 22442-3:2007)
Soveltamisala
Suomenkielistä soveltamisalaa ei ole saatavissa.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
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.
Tämän julkaisun valmistelusta Suomessa vastaa Yhteinen Toimialaliitto, www.ytl.fi.
Sisällysluettelo
Sidokset
Velvoittavat viittaukset
ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives -- Part 1: Application of risk management
ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives -- Part 2: Controls on sourcing, collection and handling
Tekninen komitea
Direktiivi
Vahvistuspäivä
26.05.2008
Julkaisupäivä
13.06.2008
Painos
1
Sivumäärä
28
Julkaisun kieli
englanti