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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 050 Date of Entry 09/17/2018 
FR Recognition Number 6-123
Standard
ASTM  E667-98 (Reapproved 2017)
Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
Scope/Abstract
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.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§880.2920 Thermometer, Clinical Mercury Class 2 FLK
Relevant FDA Guidance and/or Supportive Publications*
Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Quanzeng Wang
  FDA/OC/CDRH/OSEL/DBP/
  301-796-2612
  quanzeng.wang@fda.hhs.gov
Standards Development Organization
ASTM ASTM International http://www.astm.org/
FDA Specialty Task Group (STG)
General Plastic Surgery/General Hospital
*These are provided as examples and others may be applicable.
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