Standard: AAMI 22442-2
MEDICAL DEVICES UTILIZING ANIMAL TISSUES AND THEIR DERIVATIVES-PART 2: CONTROLS ON SOURCING, COLLECTION AND HANDLING
This standard is available for individual purchase.
IHS Standards Expert subscription, simplifies and expedites the process for finding and managing standards by giving you access to standards from over 370 standards developing organizations (SDOs).FEATURES & BENEFITS
- Maximize product development and R&D with direct access to over 1.6 million standards
- Discover new markets: Identify unmet needs and discover next-generation technologies
- Improve quality by leveraging consistent standards to meet customer and market requirements
- Minimize risk: Mitigate liability and better understand compliance regulations
- Boost efficiency: Speed up research, capture and reuse expertise
HOW TO SUBSCRIBE
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.
|Organization:||Association for the Advancement of Medical Instrumentation|
|Document Number:||aami 22442-2|
|Change Type:||COMPLETE REVISION|
|Most Recent Revision:||YES|