DS/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)


Status:
Current
Type:
Standard
Language:
English
Subject:
Under revision:
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Legislation:

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 


Legislation

Please note that this standard has not yet been harmonised and thus cannot be used for CE marking. Until harmonisation of this standard has been achieved, please use one of the following standards: 

Links

Scope

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.
NOTE 1 – Selective sourcing is considered to be especially important for transmissible spongiform
encephalopathy (TSE) risk management.
The manufacturers should refer to ISO 22442-3 for information on the validation of the elimination
and/or inactivation of viruses and TSE agents.
This part of ISO 22442 does not cover the utilization of human tissues in medical devices.
This part of ISO 22442 does not specify a quality management system for the control of all stages of
production of medical devices.
It is not a requirement of this part of ISO 22442 to have a full quality management system during manufacture,
but it does specify requirements for some of the elements of a quality management system. Attention is drawn
to the standards for quality management systems (see ISO 13485) that control all stages of production or
reprocessing of medical devices. The quality management system elements that are required by this part of
ISO 22442 can form a part of a quality management system conforming to ISO 13485.
NOTE 2 – A general principle for the application of this International Standard is that it is advisable to give due
consideration to the requirements and recommendations contained in all three parts of the standard.


Number of pages: 30

Published: 2016-02-04

Date of approval: 2015-12-15

International relationships : EN ISO 22442-2:2015 IDT ISO 22442-2:2015 IDT

ICS: 11.100.99 - Other standards related to laboratory medicine

Item number: M299769


Committees

Committee

  • CEN/TC 316
  • ISO/TC 194/SC 1
  • ISO/TC 194/SC 1

Danish committee

DS/S-258