Recognized standard
22442-1 Third edition 2020-09
FDA recognition 15-64 · ISO · Tissue Engineering
Key facts
| Recognition number | 15-64 |
|---|---|
| Designation | 22442-1 Third edition 2020-09 |
| Title | Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management |
| Standards developer | International Organization for Standardization |
| Specialty area | Tissue Engineering |
| Date of entry | Dec 21, 2020 |
| Scope (excerpt) | This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations… |
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: