Recognized standard
14698-2 First edition 2003-09-15
FDA recognition 14-395 · ISO · Sterility
Key facts
| Recognition number | 14-395 |
|---|---|
| Designation | 14698-2 First edition 2003-09-15 |
| Title | Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 2: Evaluation and Interpretation of Biocontamination Data [Including: Technical Corrigendum 1 (2004)] |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Jan 30, 2014 |
| Scope (excerpt) | ISO 14698-2:2003 gives guidance on methods for the evaluation of microbiological data and the estimation of results obtained from sampling for viable particles in risk zones for biocontamination control. It should be used, where appropriate, in conjunction with ISO 14698-1. |
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: