ISO-22442-3 › Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
ISO-22442-3
-
1ST EDITION
-
CURRENT
Document Center Inc. is an authorized dealer of ISO standards.
The following bibliographic material is provided to assist you with your purchasing decision:
The following bibliographic material is provided to assist you with your purchasing decision:
ISO 22442-3:2007 specifies requirements for the validation of the elimination and/or inactivation of viruses and TSE agents during the manufacture of medical devices (excluding in vitro diagnostic medical devices) utilizing animal tissue or products derived from animal tissue, which are non-viable or have been rendered non-viable. It applies where required by the risk management process as described in ISO 22442-1. It does not cover other transmissible and non-transmissible agents.
To find similar documents by classification:
11.100.20 (Biological evaluation of medical devices Medical microbiology, see 07.100.10)
This document comes with our free Notification Service, good for the life of the document.
This document is available in either Paper or PDF format.
Customers who bought this document also bought:
ASTM-D4169Standard Practice for Performance Testing of Shipping Containers and Systems
ASTM-F88
Standard Test Method for Seal Strength of Flexible Barrier Materials
ASTM-A484
Standard Specification for General Requirements for Stainless Steel Bars, Billets, and Forgings
Document Number
ISO 22442-3:2007
Revision Level
1ST EDITION
Status
Current
Publication Date
Dec. 15, 2007
Committee Number
ISO/TC 194/SC 1