Recognized standard
17664-1 First edition 2021-07
FDA recognition 14-578 · ISO · Sterility
Key facts
| Recognition number | 14-578 |
|---|---|
| Designation | 17664-1 First edition 2021-07 |
| Title | Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 1: Critical and semi-critical medical devices |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | May 30, 2022 |
| Scope (excerpt) | This document specifies requirements for the information to be provided by the medical device manufacturer for the processing of critical or semi-critical medical devices (i.e. a medical device that enters normally sterile parts of the human body or a medical device that comes into contact with… |
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: