Standard

SN EN ISO 22442-2:2021

Apr 2021 Current

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Abstract

This document specifies requirements for controls on the sourcing, collection, and handling (which includes storage and transport) of animals and tissues for the manufacture of medical devices utilizing materials of animal origin other than in vitro diagnostic medical devices. It applies where required by the risk management process as described in ISO 22442-1. NOTE Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats. This document does not cover the utilization of human tissues in medical devices. This document does not specify a quality management system for the control of all stages of production of medical devices.

Products specifications

Standard from INB
Published: April 1 2021
Effective: April 1 2021
Document type: EN
Pages
ISBN:

ICS: 11.100.20
Publisher: SNV
Distributor: SNV
National Committee: INB/NK 129
European TC: CEN/TC 206
International TC: ISO/TC 194

Swiss Federal Authority: SWISSMEDIC
Designated under following Swiss law: 812.213
Designated under following EU law: 93/42/EWG

Product Relations

Replaces: SN EN ISO 22442-2:2016

SN EN ISO 22442-2:2021

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