Recognized standard
14698-1:2003
FDA recognition 14-142 · ISO · Sterility
Key facts
| Recognition number | 14-142 |
|---|---|
| Designation | 14698-1:2003 |
| Title | Cleanrooms and Associated Controlled Environments - Biocontamination Control - Part 1: General Principles and Methods |
| Standards developer | International Organization for Standardization |
| Specialty area | Sterility |
| Date of entry | Sep 9, 2008 |
| Scope (excerpt) | ISO 14698:2003 establishes the principles and basic methodology of a formal system of biocontamination control (Formal System) for assessing and controlling biocontamination when cleanroom technology is applied for that purpose. It specifies the methods required for monitoring risk zones in 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: