Standard

SN EN ISO 22442-3:2008

Mar 2008 Current

Existing or new amendments and versions must be purchased separately.

Language English French German

Services Online + Pdf CHF 95.00 Online CHF 82.00

There are no extended editions available for this standard

There are no available corrigendum or amendments for this standard. Any future corrigendum and amendments will be added automatically for subscribers.

Abstract

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.

Products specifications

Standard from INB
Published: March 1 2008
Effective: March 1 2008
Document type: EN
Pages
ISBN:

ICS: 11.100.20
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 129

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: Council Directive 93/42/EEC

Product Relations

Adopted from: ISO 22442-3:2007, IDT
Replaces: SN EN 12442-3:2000

Extended editions Extended editions (0)

Version history Related Corrigenda and Amendments (0)

Version history History (2)