SR EN ISO 22442-2:2016

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

ISO 22442-2:2015 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. ISO 22442-2:2015 does not cover the utilization of human tissues in medical devices. ISO 22442-2:2015 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 standard

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General information

Status : Withdrawn
Approval date : 4/29/2016
Withdrawal date : 1/29/2021
Number of pages : 24
ICS : 11.100.99 Other standards related to laboratory medicine
Technical Committee : 377 - Medical devices

Relations with other standards:

Replaces SR EN ISO 22442-2:2008
Normative reference SR EN ISO 22442-1:2016
Replaced by SR EN ISO 22442-2:2021