| ASTM E667-98 (Reapproved 2017) Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers |
| Recognition Number | General Plastic Surgery/General Hospital |
| Recognition Date | 2018-09-17 |
| Recognition List | 050 |
| Recognition Number | 6-123 |
| 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 |
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1.1 This specification covers mercury-in-glass, reusable maximum self-registering clinical thermometers of the types commonly used for measuring body temperatures of humans and of animals. Requirements are given for bulb and stem glasses, mercury, legibility and permanency of markings, dimensions, temperature scale ranges, and graduations, as well as for thermometer stability, ease of resetting, retention of temperature indication, and for accuracy of scale reading. Appropriate methods of testing to determine compliance are provided. Also included is a glossary of terms used in the standard and an appendix with additional information on thermometer glasses and stability.
1.2 All values of temperature in this standard are with reference to the International Temperature Scale of 1990.
1.3 This specification was developed to provide nationally recognized marketing classifications and quality requirements for mercury-in-glass, maximum self-registering clinical thermometers. It is also intended to provide producers, distributors, and users with a common understanding of the characteristics of this product.
1.4 The following precautionary statement pertains only to the test method portion, Section 6 of this specification: This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use.
| Regulation Number | Device Name | Device Class | Product Code |
| §880.2920 | Thermometer, Clinical Mercury | Class 2 | FLK |
| There is no relevant guidance developed at this time. |