| ASTM E1112-00 (Reapproved 2011) Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature |
| Recognition Date | 2012-03-16 |
| Recognition List | 028 |
| Recognition Number | 6-177 |
| Extent | Complete standard |
| Standards Orgs | ASTM ASTM International http://www.astm.org/ |
| STG | General Plastic Surgery/General Hospital |
| FDA Tech | Robert Meyer FDA/OMPT/CTP/OS/DPS/ 240-402-1842 Robert.Meyer@fda.hhs.gov |
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
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 are to be regarded separately as standard. The values stated in each system may not be exact equivalents; therefore, each system shall be used independently of the other. Combining values from the two systems may result in non-conformance with the standard.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.2910 | Thermometer, Electronic, Clinical | Class 2 | FLL |
| Guidance on the Content of Premarket Notification [510(k)] Submissions for Clinical Electronic Theromometers, Issued March 1993 |