Recognized standard
TIR 17665-2:2009 TS 17665-2 First edition 2009-01-15
FDA recognition 14-277 · ISO · Sterility
Key facts
| Recognition number | 14-277 |
|---|---|
| Designation | TIR 17665-2:2009 TS 17665-2 First edition 2009-01-15 |
| Title | Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO ANSI/AAMI/ISO 17665-1 Sterilization of health care products - Moist heat - Part 2: Guidance on the application of ISO 17665-1 |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Apr 4, 2016 |
| Scope (excerpt) | ISO/TS 17665-2:2009 provides general guidance on the development, validation and routine control of moist heat sterilization processes and is intended to explain the requirements set forth in ISO 17665-1. The guidance given in this Technical Specification is provided to promote good practice related… |
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: