Recognized standard
/TS 19930 First edition 2017-12
FDA recognition 14-533 · ISO · Sterility
Key facts
| Recognition number | 14-533 |
|---|---|
| Designation | /TS 19930 First edition 2017-12 |
| Title | Guidance on aspects of a risk-based approach to assuring sterility of terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a sterility assurance level of 10-6 |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | ISO/TS 19930:2017 provides guidance on identifying the aspects to be considered as part of a risk-based approach to selecting a sterility assurance level (SAL) for terminally sterilized, single-use health care product that is unable to withstand processing to achieve maximally a SAL of 10-6. In… |
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: