Active
, Reaffirmed
Standard
Most Recent
ISO 22442-3:2007 (R2022)
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
Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents
Summary
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.
Notes
90.93 : Norme internationale confirmée
Technical characteristics
| Publisher | International Organization for Standardization (ISO) |
| Publication Date | 11/27/2007 |
| Confirmation Date | 09/14/2022 |
| Edition | 1 |
| Page Count | 22 |
| EAN | --- |
| ISBN | --- |
| Weight (in grams) | --- |
No products.