ASTM E1965-98(2016)

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

ABSTRACT
This specification covers infrared thermometers, which are electronic instruments intended for the intermittent measurement and monitoring of patient temperatures by means of detecting the intensity of thermal radiation between the subject of measurement and the sensor. The specification addresses the assessment of the subject's internal body temperature through measurement of thermal emission from the ear canal. Though, performance requirements for noncontact temperature measurement of skin are also provided. Limits are set for laboratory accuracy, and determination and disclosure of clinical accuracy of the covered instruments are required. Performance and storage limits under various environmental conditions, requirements for labeling, and test procedures are all established herein.
SCOPE
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.2
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.3  
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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2016
• ICS: 17.040.20 - Properties of surfaces
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E1965 − 98 (Reapproved 2016)
Standard Specification for
Infrared Thermometers for Intermittent Determination of
1
Patient Temperature
This standard is issued under the fixed designation E1965; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope* 2. Referenced Documents
4
2.1 ASTM Standards:
1.1 This specification covers electronic instruments in-
E177 Practice for Use of the Terms Precision and Bias in
tended for intermittent measuring and monitoring of patient
ASTM Test Methods
temperatures by means of detecting the intensity of thermal
E344 Terminology Relating to Thermometry and Hydrom-
radiation between the subject of measurement and the sensor.
etry
1.2 The specification addresses assessing subject’s body
E667 Specification for Mercury-in-Glass, Maximum Self-
internal temperature through measurement of thermal emission
Registering Clinical Thermometers
from the ear canal. Performance requirements for noncontact
E1112 Specification for Electronic Thermometer for Inter-
temperature measurement of skin are also provided.
mittent Determination of Patient Temperature
1.3 The specification sets limits for laboratory accuracy and
2.2 International Electrotechnical Commission Standards:
requires determination and disclosure of clinical accuracy of
IEC 601-1-2: 1993 Medical Electrical Equipment, Part 1;
the covered instruments.
General Requirements for Safety. Collateral Standard:
3
Electromagnetic Compatibility—Requirements and Tests
1.4 Performance and storage limits under various environ-
IEC 1000-4-2: 1995 Electromagnetic Compatibility
mental conditions, requirements for labeling and test proce-
(EMC)—Part 4: Testing and Measurement Techniques;
dures are established.
Section 2: Electrostatic Discharge Immunity Test: Basic
NOTE 1—For electrical safety consult Underwriters Laboratory Stan-
3
2
EMC Publication (Rev. of IEC 801-2)
dards.
3
NOTE 2—For electromagnetic emission requirements and tests refer to IEC 1000-4-3: 1995 Electromagnetic Compatibility
CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic
2.3 Other Standards:
Disturbance Characteristics of Industrial, Scientific, and Medical (ISM)
International Vocabulary of Basic and General Terms in
3
Radiofrequency Equipment.
3
Metrology (VIM)
1.5 The values of quantities stated in SI units are to be
regarded as the standard. The values of quantities in parenthe- 3. Terminology
ses are not in SI and are optional.
3.1 Definitions—The definitions given in Terminology E344
1.6 The following precautionary caveat pertains only to the apply.
test method portion, Section 6, of this specification: This
3.2 Definitions of Terms Specific to This Standard:
standard does not purport to address all of the safety concerns,
3.2.1 The terms defined below are for the purposes of this
if any, associated with its use. It is the responsibility of the user
specification only. Manufacturers should use this terminology
of this standard to establish appropriate safety and health
in labeling instruments and in technical and sales literature.
practices and determine the applicability of regulatory limita-
3.2.2 accuracy, n—ability of an infrared thermometer to
tions prior to use.
give a reading close to the true temperature.
3.2.3 adjusted mode, n—output of an IR thermometer that
gives the temperature measured and calculated from a subject
1
This specification is under the jurisdiction of ASTM Committee F04 on
or object, by correcting such temperature for variations in
Medical and Surgical Materials and Devices and is the direct responsibility of
ambient temperature, the subject’s temperature, emissivity,
Subcommittee F04.33 on Medical/Surgical Instruments.
body site (that is, oral, or rectal), etc.
Current edition approved Oct. 1, 2016. Published October 2016. Originally
approved in 1998. Last previous edition approved in 2009 as E1965 – 98 (2009).
DOI: 10.1520/E1965-98R16.
2 4
Available from Underwriters Laboratories (UL), 2600 N.W. Lake Rd., Camas, For referenced ASTM standards, visit the ASTM website, www.astm.org, or
WA 98607-8542, http://www.ul.com. contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3
Available from Global Engineering Documents, 15 Inverness Way East, Standards volume information, refer to the standard’s Document Summary page on
Englewood, CO 80112. the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E1965 − 98 (Reapproved 2009) E1965 − 98 (Reapproved 2016)
Standard Specification for
Infrared Thermometers for Intermittent Determination of
1
Patient Temperature
This standard is issued under the fixed designation E1965; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Scope*
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’ssubject’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.
2
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
3
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.
2. Referenced Documents
4
2.1 ASTM Standards:
E177 Practice for Use of the Terms Precision and Bias in ASTM Test Methods
E344 Terminology Relating to Thermometry and Hydrometry
E667 Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
E1112 Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
2.2 International Electrotechnical Commission Standards:
IEC 601-1-2: 1993 Medical Electrical Equipment, Part 1; General Requirements for Safety. Collateral Standard: Electromagnetic
3
Compatibility—Requirements and Tests
IEC 1000-4-2: 1995 Electromagnetic Compatibility (EMC)—Part 4: Testing and Measurement Techniques; Section 2:
3
Electrostatic Discharge Immunity Test: Basic EMC Publication (Rev. of IEC 801-2)
3
IEC 1000-4-3: 1995 Electromagnetic Compatibility
2.3 Other Standards:
3
International Vocabulary of Basic and General Terms in Metrology (VIM)
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.33 on Medical/Surgical Instruments.
Current edition approved May 1, 2009Oct. 1, 2016. Published July 2009October 2016. Originally approved in 1998. Last previous edition approved in 20032009 as
E1965 – 98 (2003).(2009). DOI: 10.1520/E1965-98R09. 10.1520/E1965-98R16.
2
Available from Underwriters Laboratories Inc., 1655 Scott Blvd., Santa Clara, CA 95050.(UL), 2600 N.W. Lake Rd., Camas, WA 98607-8542, http://www.ul.com.
3
Available from Global Engineering Documents, 15 Inverness Way East, Englewood, CO 80112.
4
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to the standard’sstandard’s Document Summary page on the ASTM website.
*A Summary of Changes section appears at the end of this standard
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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E1965 − 98 (2016)
3. Terminology
3.1 Definitions—The definitions given in Terminology E344 apply.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 The terms defined below are for the purposes of this specification only. Manufacturers should use this terminology in
labeling instrumen
...