Recognized standard
22442-3 First edition 2007-12-15
FDA recognition 15-47 · ISO · Tissue Engineering
Key facts
| Recognition number | 15-47 |
|---|---|
| Designation | 22442-3 First edition 2007-12-15 |
| Title | 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. |
| Standards developer | International Organization for Standardization |
| Specialty area | Tissue Engineering |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | This part of ISO 22442 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… |
At a glance
- None Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: