Recognized standard
E1112-00(2018)
FDA recognition 6-177 · ASTM · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-177 |
|---|---|
| Designation | E1112-00(2018) |
| Title | Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| Standards developer | ASTM International |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Mar 16, 2012 |
| Device classes | Class 2 |
| Scope (excerpt) | 1.1 This specification covers electronic instruments intended for intermittent monitoring of patient temperatures. 1.2 This specification does not cover infrared thermometers. Specification E1965 covers specifications for IR thermometers. 1.3 The values stated in either SI units or inch-pound units… |
At a glance
- 1–9 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: