ANSI/AAMI/ISO 22442-2-2016 pdf download.Medical devices utilizing animal tissues and their derivatives—Part 2: Controls on sourcing, collection and handling.
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 1 3485.
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.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are indispensable for its application. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 22442-1 :201 5, Medical devices utilizing animal tissues and their derivatives—Part 1: Application of risk management
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 22442-1 and the following apply.
3.1 collection
removal of tissues from animals
3.2 low risk herd
closed herd
herd of bovine animals in which, for at least the previous eight years:
a) there has been documented veterinary monitoring;
b) there has been no case of BSE;
c) there has been no feeding of mammalian-derived protein;
d) there is a fully documented breeding history;
e) there is a fully documented use of veterinary medicines and vaccines;
f) each animal is traceable;
g) genetic material has been introduced only from herds with the same BSE-free status.ANSI/AAMI/ISO 22442-2 pdf download.