ISO 22442:2020
ISO 22442:2020 Medical devices utilizing animal tissues and their derivatives – Part 2: Controls on sourcing, collection and handling
CDN $186.00
Description
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‚Äë1.
NOTE 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.
Edition
3
Published Date
2020-09-15
Status
PUBLISHED
Pages
15
Language
English
Format
Secure PDF
Secure – PDF details
- Save your file locally or view it via a web viewer
- Viewing permissions are restricted exclusively to the purchaser
- Device limits - 3
- Printing – Enabled only to print (1) copy
See more about our Environmental Commitment
Abstract
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‚Äë1.
NOTE 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.
Previous Editions
Can’t find what you are looking for?
Please contact us at:
Related Documents
-
ISO 10993:2020 Biological evaluation of medical devices – Part 18: Chemical characterization of medical device materials within a risk management process
CDN $418.00 Add to cart -
ISO 20776:2021 Clinical laboratory testing and in vitro diagnostic test systems – Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices – Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
CDN $186.00 Add to cart -
ISO 10993:2023 Biological evaluation of medical devices – Part 55: Interlaboratory study on cytotoxicity
CDN $251.00 Add to cart -
ISO 14155:2020 Clinical investigation of medical devices for human subjects – Good clinical practice
CDN $422.00 Add to cart
