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EVS-EN ISO 22442-2:2015

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2015)

General information

Withdrawn from 31.12.2020
Base Documents
ISO 22442-2:2015; EN ISO 22442-2:2015
ICS Groups
11.100.99 Other standards related to laboratory medicine
Directives or regulations
None

Standard history

Status
Date
Type
Name
31.12.2020
Main
EVS-EN ISO 22442-2:2020
05.01.2016
Main
EVS-EN ISO 22442-2:2015
07.02.2008
Main
EVS-EN ISO 22442-2:2008
This part of ISO 22442 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.

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Standard monitoring
English (PDF 363 KB)

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Standards designation

EVS Estonian standard
EN European standard (published by an CEN or CENELEC)
EN ISO International standard adopted as an European standard
ISO International Organization for Standardization’s standard
IEC International Electrotechnical Commission’s standard
HD CENELEC’s harmonisation document
   
EVS-EN European standard implemented in Estonia
EVS-EN ISO International standard adopted in Europe and implemented in Estonia
EVS-EN ISO/IEC International standard/International electrotechnical standard adopted in Europe and implemented in Estonia
EVS-IEC International electrotechnical standard implemented in Estonia
EVS-ISO International standard implemented in Estonia
   
A, AMD amedment
+A a full standard plus the amendment
/A only amendment
COR, AC corrigendum
+COR a full standard plus the corrigendum
NA national annex
+NA a full standard plus the national annex
/NA only national annex
TS technical specification
TR technical report
CWA agreement, developed by a CEN or CENELEC
prEVS-EN (etc) draft standard
   
et the standard is in Estonian only
en the standard is in English only
et-en the standard is in Parallel text Estonian-English