Recognized standard
22442-2 Third edition 2020-09
FDA recognition 15-65 · ISO · Tissue Engineering
Key facts
| Recognition number | 15-65 |
|---|---|
| Designation | 22442-2 Third edition 2020-09 |
| Title | Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling |
| Standards developer | International Organization for Standardization |
| Specialty area | Tissue Engineering |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | 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… |
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: