ASTM E1061-01 (Reapproved 2014)

Standard Organization:

ASTM E1061-01 (Reapproved 2014)
Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers

• Recognition Date: 2015-08-14
• Recognition List: 040
• Recognition Number: 6-200
• 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

Rationale:

This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

Scope:

1.1 This specification covers direct-reading liquid crystal forehead thermometers designed to monitor trends or measure human forehead surface temperatures, or both.

1.2 Thermometers covered by this specification are generally available in continuous or intermittent reading modes. Thermometers meeting the requirements specified herein shall be considered as complying with this specification.

1.3 The following precautionary caveat pertains only to the test method portion, Section 5, 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 consult and establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

Code of Federal Regulations:

Regulation Number	Device Name	Device Class	Product Code
§880.2200	Strip, Temperature, Forehead, Liquid Crystal	Class 2	KPD

FDA Guidance:

There is no relevant guidance developed at this time.