Recognized standard
11607-1 Second edition 2019-02 11607-1:2019
FDA recognition 14-530 · ISO · Sterility
Key facts
| Recognition number | 14-530 |
|---|---|
| Designation | 11607-1 Second edition 2019-02 11607-1:2019 |
| Title | Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jul 15, 2019 |
| Scope (excerpt) | This document specifies requirements and test methods for materials, preformed sterile barrier systems, sterile barrier systems and packaging systems that are intended to maintain sterility of terminally sterilized medical devices until the point of use. It is applicable to industry, to health care… |
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: