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ISO FDIS 22442-2 2015 Edition, July 30, 2015 MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES - PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
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Description / Abstract:
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.