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.
ISO 22442-2:2007 Referenced Document
ISO 22442-1:2007 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
ISO 22442-2:2007 history
2020ISO 22442-2:2020 Medical devices utilizing animal tissues and their derivatives — Part 2: Controls on sourcing, collection and handling
2015ISO 22442-2:2015 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
2007ISO 22442-2:2007 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling