Recognized standard
13408-6 Second edition 2021-04
FDA recognition 14-563 · ISO · Sterility
Key facts
| Recognition number | 14-563 |
|---|---|
| Designation | 13408-6 Second edition 2021-04 |
| Title | Aseptic processing of health care products - Part 6: Isolator systems |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Dec 20, 2021 |
| Scope (excerpt) | This document specifies the requirements for and provides guidance on the specification, selection, qualification, bio-decontamination, validation, operation and control of isolator systems related to aseptic processing of health care products and processing of cell-based health care products. This… |
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: