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ASTM E1965-98(2003)

(Specification)

Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature

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.
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.

General Information

Status
Historical
Publication Date
09-May-2003
ICS
17.040.20 - Properties of surfaces
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.33 - Medical/Surgical Instruments
Current Stage
Ref Project

Relations

Replaces
ASTM E1965-98 - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Effective Date
10-May-2003
Replaced By
ASTM E1965-98(2009) - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
Effective Date
01-May-2009
Referred By
ASTM E1112-00(2018) - Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
Effective Date
10-May-2003
Referred By
ASTM E344-20 - Terminology Relating to Thermometry and Hydrometry
Effective Date
10-May-2003

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ASTM E1965-98(2003) - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient TemperatureASTM E1965-98(2003) - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
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ASTM E1965-98(2003) - Standard Specification for Infrared Thermometers for Intermittent Determination of Patient Temperature
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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: E 1965 – 98 (Reapproved 2003)
Standard Specification for
Infrared Thermometers for Intermittent Determination of
1
Patient Temperature
This standard is issued under the fixed designation E 1965; 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
1.1 This specification covers electronic instruments in- 2.1 ASTM Standards:
tended for intermittent measuring and monitoring of patient E 177 Practice for Use of the Terms Precision and Bias in
4
temperatures by means of detecting the intensity of thermal ASTM Test Methods
radiation between the subject of measurement and the sensor. E 344 Terminology Relating to Thermometry and Hydrom-
5
1.2 The specification addresses assessing subject’s body etry
internal temperature through measurement of thermal emission E 667 Specification for Mercury-in-Glass Maximum Self-
5
from the ear canal. Performance requirements for noncontact Registering Clinical Thermometers
temperature measurement of skin are also provided. E 1112 Specification for ElectronicThermometers for Inter-
5
1.3 The specification sets limits for laboratory accuracy and mittent Determination of Patient Temperature
requires determination and disclosure of clinical accuracy of 2.2 International Electrotechnical Commission Standards:
the covered instruments. IEC 601-1-2: 1993 Medical Electrical Equipment, Part 1;
1.4 Performance and storage limits under various environ- General Requirements for Safety. Collateral Standard:
3
mental conditions, requirements for labeling and test proce- Electromagnetic Compatibility—Requirements and Tests
dures are established. IEC 1000-4-2: 1995 Electromagnetic Compatibility
(EMC)—Part 4: Testing and Measurement Techniques;
NOTE 1—For electrical safety consult Underwriters Laboratory Stan-
2 Section 2: Electrostatic Discharge Immunity Test: Basic
dards .
3
EMC Publication (Rev. of IEC 801-2)
NOTE 2—For electromagnetic emission requirements and tests refer to
3
CISPR 11: 1990 Lists of Methods of Measurement of Electromagnetic IEC 1000-4-3: 1995 Electromagnetic Compatibility
Disturbance Characteristics of Industrial, Scientific, and Medical (ISM)
2.3 Other Standards:
3
Radiofrequency Equipment .
International Vocabulary of Basic and General Terms in
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
1.6 The following precautionary caveat pertains only to the
E 344 apply.
test method portion, Section 6, of this specification: This
3.2 Definitions of Terms Specific to This Standard—The
standard does not purport to address all of the safety concerns,
terms defined below are for the purposes of this specification
if any, associated with its use. It is the responsibility of the user
only. Manufacturers should use this terminology in labeling
of this standard to establish appropriate safety and health
instruments and in technical and sales literature.
practices and determine the applicability of regulatory limita-
3.2.1 accuracy, n—ability of an infrared thermometer to
tions prior to use.
give a reading close to the true temperature.
3.2.2 adjusted mode, n—output of an IR thermometer that
1
gives temperature measured and calculated from a subject or
This specification is under the jurisdiction of ASTM Committee E20 on
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
object, by correcting such temperature for variations in ambi-
on Medical Thermometry.
ent temperature, subject’s temperature, emissivity, body site
Current edition approved May 10, 2003. Published July 2003. Originally
(that is, oral,or rectal), etc.
approved in 1998. Last previous edition approved in 1998 as E 1965 – 98.
2
Available from Underwriters Laboratories Inc., 1655 Scott Blvd., Santa Clara,
CA 95050.
3 4
Available from Global Engineering Documents, 15 Inverness Way East, Annual Book of ASTM Standards, Vol 14.02.
5
Englewood, CO 80112. Annual Book of ASTM Standards, Vol 14.03.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
1

---------------------- Page: 1 ----------------------
E 1965 – 98 (2003)
3.2.3 axillary temperature [t ], n—temperature at the apex 3.2.19 infrared (IR), adj—of the electromagnetic radiation
ba
of either axilla (armpit) as measured by a contact thermometer. within the mid- and far infrared spectral ranges (approximately
from 3 to 30 µm wavelength).
3.2.4 blackbody,
...

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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.
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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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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1.1 This test method covers a laboratory procedure for determining the wear of materials and friction during sliding using a pin-on-disk apparatus. Materials are tested in pairs under nominally non-abrasive conditions. The principal areas of experimental attention in using this type of apparatus to measure wear are described.  
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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.  
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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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

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3.1 This terminology standard contains definitions of appearance terms applicable to the work of many ASTM technical committees. Its use by committees other than Committee E12 on Color and Appearance, and its citation in the standards of such committees, is encouraged.  
3.2 In this terminology standard, definitions of terms used in other ASTM standards are indicated by placing the designation of that standard in parentheses at the end of the definition. Definitions used by other organizations (see Refs (3–4)) are indicated similarly by placing in parentheses at the end of the definition the acronym of the organization, occasionally with the date of its terminology standard quoted. In either case, a superscript letter may be used to indicate the degree of correspondence between the definition given herein and that in the citation. Superscript A indicates that the two are identical; B that the given definition is a modification of that cited, with little difference in essential meaning; and C that the two differ substantially.  
3.3 A further parenthetical inclusion at the end of the definition gives the revision, if after 1981, in which the definition was added to this terminology standard or last revised.  
3.4 Where appropriate, symbols or acronyms are listed for terms in this terminology standard. Since usage varies, these listings should be considered as recommendations, not as mandatory. If a different symbol or acronym is used in another ASTM standard, this should be indicated in that standard.  
3.5 In the 1990 edition of this terminology standard, a great many terms were relocated to conform to the recommendation of the Form and Style for ASTM Standards, (Blue Book) that listings be in spoken word order. In general, there are no cross-references between the old and new listings, except where a special function is served. An example of such a special function is to list all terms relating to a given basic quantity, for example, all terms defining various ...
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SCOPE
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1.4 Coating thickness can vary widely across a surface. As a result, obtaining single-point measurements may not accurately represent the actual coating system thickness. SSPC-PA 2 prescribes a frequency of coating thickness measurement based on the size of the area coated. A frequency of measurement for coated steel beams (girders) and coated test panels is also provided in the appendices to SSPC-PA 2. The governing specification is responsible for providing the user with the minimum and the maximum coating thickness for each layer, and for the total coating system.  
1.5 The values stated in SI units are to be regarded as standard. The values given in parentheses after SI units are provided for information only and are not considered standard.  
1.6 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.  
1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

  • Standard
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    English language
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  • Standard
    7 pages
    English language
    sale 15% off