Recognized standard
13004 First edition 2022-10 13004:2022
FDA recognition 14-605 · ISO · Sterility
Key facts
| Recognition number | 14-605 |
|---|---|
| Designation | 13004 First edition 2022-10 13004:2022 |
| Title | Sterilization of health care products - Radiation - Substantiation of selected sterilization dose: Method VDmaxSD |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Sep 9, 2024 |
| Scope (excerpt) | This document describes a method for substantiating a selected sterilization dose of 17,5 kGy, 20 kGy, 22,5 kGy, 27,5 kGy, 30 kGy, 32,5 kGy or 35 kGy that achieves a sterility assurance level (SAL) of 10^-6 or less for radiation sterilization of health care products. This document also specifies a… |
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: