BS EN ISO 22442-2:2020 PDF Download
Standard EN Sample
Medical devices utilizing animal tissues and their derivatives. Controls on sourcing, collection and handling
Also Known As:
This document 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.
Selective sourcing is especially important for transmissible spongiform encephalopathy (TSE) risk management, i.e. when utilising animal tissue and/or their derivative originating from bovine, ovine and caprine species, deer, elk, mink or cats.
This document does not cover the utilization of human tissues in medical devices.
This document does not specify a quality management system for the control of all stages of production of medical devices.
| Descriptors | Animal products, Animal freight, Storage, Medical sciences, Bovine animals, Veterinary science, Animals, Cells (biology), Medical equipment, Inspection, Environmental health, Acceptance (approval), Quality control |
| ICS Codes | 11.020.20 - Medical science 11.100.20 - Biological evaluation of medical devices 11.100.99 - Other standards related to laboratory medicine |
| Language(s) | English |
| ISBN | 978 0 539 01670 3 |
| File Size | 1.3 MB |
