Recognized standard
PB70:2012
FDA recognition 6-296 · ANSI · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-296 |
|---|---|
| Designation | PB70:2012 |
| Title | Liquid barrier performance and classification of protective apparel and drapes intended for use in health care facilities |
| Standards developer | American National Standards Institute |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Aug 6, 2013 |
| Device classes | Class 2 |
| Scope (excerpt) | This standard establishes a system of classification for protective apparel and drapes used in healthcare facilities based on their liquid barrier performance and specifies related labeling requirements and standardized test methods for determining compliance. The standard is intended to ultimately… |
At a glance
- 10–99 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: