Recognized standard
11607-2 Second edition 2019-02 11607-2:2019
FDA recognition 14-531 · ISO · Sterility
Key facts
| Recognition number | 14-531 |
|---|---|
| Designation | 11607-2 Second edition 2019-02 11607-2:2019 |
| Title | Packaging for terminally sterilized medical devices - Part 2: Validation requirements for forming, sealing and assembly processes |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | This document specifies requirements for the development and validation of processes for packaging medical devices that are terminally sterilized. These processes include forming, sealing and assembly of preformed sterile barrier systems, sterile barrier systems and packaging systems. It is… |
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: