Recognized standard
17665-1 First edition 2006-08-15 17665-1:2006/(R)2013
FDA recognition 14-333 · ISO · Sterility
Key facts
| Recognition number | 14-333 |
|---|---|
| Designation | 17665-1 First edition 2006-08-15 17665-1:2006/(R)2013 |
| Title | Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices Sterilization of health care products -- Moist heat -- Part 1: Requirements for the development, validation, and routine… |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | ISO 17665-1:2006 specifies requirements for the development, validation and routine control of a moist heat sterilization process for medical devices. Moist heat sterilization processes covered by ISO 17665-1:2006 include but are not limited to: -saturated steam venting systems; -saturated steam… |
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: