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ASTM E 1965 : 1998 : R2009

Superseded
Superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

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superseded

A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Available format(s)

Hardcopy , PDF

Superseded date

11-11-2014

Language(s)

English

Published date

01-05-2009

CONTAINED IN VOL. 14.03, 2016 Defines electronic instruments intended for intermittent measuring and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor.

1.1 This specification covers electronic instruments intended for intermittent measuring and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor.

1.2 The specification addresses assessing subject's body internal temperature through measurement of thermal emission from the ear canal. Performance requirements for noncontact temperature measurement of skin are also provided.

1.3 The specification sets limits for laboratory accuracy and requires determination and disclosure of clinical accuracy of the covered instruments.

1.4 Performance and storage limits under various environmental conditions, requirements for labeling and test procedures are established.

Note 1—For electrical safety consult Underwriters Laboratory Standards.

Note 2—For electromagnetic emission requirements and tests refer to CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic Disturbance Characteristics of Industrial, Scientific, and Medical (ISM) Radiofrequency Equipment.

1.5 The values of quantities stated in SI units are to be regarded as the standard. The values of quantities in parentheses are not in SI and are optional.

1.6 The following precautionary caveat 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 and health practices and determine the applicability of regulatory limitations prior to use.

Committee
F 04
DocumentType
Standard
Pages
17
ProductNote
Reconfirmed 2009
PublisherName
American Society for Testing and Materials
Status
Superseded
SupersededBy
Supersedes

ASTM E 1112 : 2000 : R2018 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

ASTM E 177 : 2014 : REDLINE Standard Practice for Use of the Terms Precision and Bias in ASTM Test Methods
IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
ISO/IEC Guide 99:2007 International vocabulary of metrology Basic and general concepts and associated terms (VIM)
ASTM E 344 : 2016-12 TERMINOLOGY RELATING TO THERMOMETRY AND HYDROMETRY
IEC 61000-4-2:2008 Electromagnetic compatibility (EMC) - Part 4-2: Testing and measurement techniques - Electrostatic discharge immunity test
IEC 61000-4-3:2006+AMD1:2007+AMD2:2010 CSV Electromagnetic compatibility (EMC) - Part 4-3: Testing and measurement techniques - Radiated, radio-frequency, electromagnetic field immunity test
ASTM E 1112 : 2000 Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

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