Recognized standard
/TS 16775 Second edition 2021-11 TIR16775:2023
FDA recognition 14-585 · ISO · Sterility
Key facts
| Recognition number | 14-585 |
|---|---|
| Designation | /TS 16775 Second edition 2021-11 TIR16775:2023 |
| Title | Packaging for terminally sterilized medical devices - Guidance on the application of ISO 11607-1 and ISO 11607-2 |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | May 29, 2023 |
| Scope (excerpt) | This document provides guidance for the application of the requirements contained in ISO 11607-1 and ISO 11607-2. It does not add to, or otherwise change, the requirements of ISO 11607-1 and ISO 11607-2. This is an informative document, not normative. It does not include requirements to be used as… |
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: