DIN EN ISO 22442-2:2008
Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007); English version of DIN EN ISO 22442-2:2008-03

Standard No.

DIN EN ISO 22442-2:2008

Release Date

2008

Published By

German Institute for Standardization

Status

Be replaced

Replace By

DIN EN ISO 22442-2:2016

DIN EN ISO 22442-2 E:2015-08

Latest

DIN EN ISO 22442-2:2016

DIN EN ISO 22442-2:2018

DIN EN ISO 22442-2:2021-04

DIN EN ISO 22442-2 E:2015-08

Replace

DIN EN 12442-2:2001 DIN EN ISO 22442-2:2006

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. NOTE 2 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. NOTE 3 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 4 A general principle for the application of ISO 22442 is that it is advisable to give due consideration to the requirements and recommendations contained in all three parts of the standard.

DIN EN ISO 22442-2:2008 Referenced Document

• ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management

DIN EN ISO 22442-2:2008 history

• 2021 DIN EN ISO 22442-2:2021 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020
• 1970 DIN EN ISO 22442-2 E:2018-12 Animal tissues and their derivatives for use in medical devices Part 2: Source, collection and processing controls (draft)
• 2018 DIN EN ISO 22442-2 E:2018 Draft Document - Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO/DIS 22442-2:2018); German and English version prEN ISO 22442-2:2018
• 2016 DIN 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); German version EN ISO 22442-2:2015
• 2008 DIN EN ISO 22442-2:2008 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2007); English version of DIN EN ISO 22442-2:2008-03
• 0000 DIN EN ISO 22442-2:2006
• 0000 DIN EN 12442-2:2001