ASTM E1299-96(2016)

Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature

SCOPE
1.1 This specification covers reusable phase-change-type clinical thermometers.  
1.2 The following safety hazards 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: 17.200.20 - Temperature-measuring instruments
• 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E1299 − 96 (Reapproved 2016)
Standard Specification for
Reusable Phase-Change-Type Fever Thermometer for
1
Intermittent Determination of Human Temperature
This standard is issued under the fixed designation E1299; 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 4. Classification
1.1 This specification covers reusable phase-change-type 4.1 Phase-change-type reusable thermometers for determi-
clinical thermometers. nation of human temperature.
1.2 The following safety hazards caveat pertains only to the
4.2 Scales, Celsius and Fahrenheit.
test method portion, Section 6, of this specification. This
standard does not purport to address all of the safety concerns,
5. Requirements
if any, associated with its use. It is the responsibility of the user
5.1 General—All thermometers complying with this speci-
of this standard to establish appropriate safety and health
fication shall meet all the requirements specified herein.
practices and determine the applicability of regulatory limita-
5.2 Temperature Range—The instrument shall cover the
tions prior to use.
minimum range from 35.5 to 40.4 °C (96.0 to 104.8 °F).
2. Referenced Documents
5.3 Accuracy—Within the range specified, no individual
2
2.1 ASTM Standards:
reading shall be in error by more than the maximum errors
E344 Terminology Relating to Thermometry and Hydrom-
listed in Table 1 when tested in accordance with 6.2 at any
etry
point on the temperature scale of the thermometer.
F895 Test Method for Agar Diffusion Cell Culture Screening
5.4 Measurement Retention—A measurement meeting the
for Cytotoxicity
accuracy requirement of 5.3 will be maintained for a minimum
3
2.2 Code of Federal Regulations :
of 20 s when tested in accordance with 6.2.4.
CFR, Title 21, Section 191, II, 1971
5.5 Operating Environment—When used in an environment
3. Terminology
in which the temperature is in the range of 18 to 33 °C (64 to
92 °F), the thermometers, when tested in accordance with 6.3,
3.1 Definitions:
shall meet the requirements of 5.3 and 5.4.
3.1.1 The definitions given in Terminology E344 apply to
this standard. 5.6 Graduation—The thermometer shall be graduated in
3.2 Definitions of Terms Specific to This Standard:
intervals no greater than 0.1 °C (0.2 °F). As a minimum,
3.2.1 phase-change-type fever thermometer, n—a reusable appropriate numerals shall be placed at every half degree
instrument utilizing the change of state of chemical composi-
graduation for Celsius scale thermometers and every degree
tions to measure and indicate an anatomical site temperature.
graduation for Fahrenheit scale thermometers.
3.2.2 retention time, n—the duration of time that the optimal
5.7 Stability—Thermometers shall meet all requirements of
signal for reading persists.
this specification over their minimum shelf life of three years.
5.8 Storage Environment—When tested in accordance with
1
This specification is under the jurisdiction of ASTM Committee F04 on 6.4, thermometers shall meet the requirements of 5.3 after
Medical and Surgical Materials and Devices and is the direct responsibility of
having been stored in an environment of − 20 to 50 °C ( + 4 °F
Subcommittee F04.33 on Medical/Surgical Instruments.
to 120 °F), and a relative humidity of 15 to 85 %
Current edition approved Oct. 1, 2016. Published October 2016. Originally
noncondensing, for a period of thirty days, providing that they
approved in 1989. Last previous edition approved in 2010 as E1299 – 96 (2010).
DOI: 10.1520/E1299-96R16.
have been returned to an environment with a temperature of
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
between 18 to 33 °C (64 to 92 °F) and a relative humidity of
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
30 to 70 % for at least 24 h before testing.
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
5.9 Marking and Labeling:
3
Available from U.S. Government Printing Office Superintendent of Documents,
5.9.1 Identification—Suitable packaging units of the ther-
732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov. mometer shall bear in legible characters the name or
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1299 − 96 (2016)
TABLE 1 Maximum Error of Temperature Readings
6.2.3 Sampling—For each manufacturing lot, use a mini-
Celsius Scale mum of 200 thermometers in the accuracy determination,
Te
...

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: E1299 − 96 (Reapproved 2010) E1299 − 96 (Reapproved 2016)
Standard Specification for
Reusable Phase-Change-Type Fever Thermometer for
1
Intermittent Determination of Human Temperature
This standard is issued under the fixed designation E1299; 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
1.1 This specification covers reusable phase-change-type clinical thermometers.
1.2 The following safety hazards 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
2
2.1 ASTM Standards:
E344 Terminology Relating to Thermometry and Hydrometry
F895 Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity
3
2.2 Code of Federal Regulations :
CFR, Title 21, Section 191, II, 1971
3. Terminology
3.1 Definitions:
3.1.1 The definitions given in Terminology E344 apply to this standard.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 phase-change-type fever thermometer, n—a reusable instrument utilizing the change of state of chemical compositions to
measure and indicate an anatomical site temperature.
3.2.2 retention time, n—the duration of time that the optimal signal for reading persists.
4. Classification
4.1 Phase-change-type reusable thermometers for determination of human temperature.
4.2 Scales, Celsius and Fahrenheit.
5. Requirements
5.1 General—All thermometers complying with this specification shall meet all the requirements specified herein.
5.2 Temperature Range—The instrument shall cover the minimum range from 35.5 to 40.4 °C (96.0 to 104.8 °F).
5.3 Accuracy—Within the range specified, no individual reading shall be in error by more than the maximum errors listed in
Table 1 when tested in accordance with 6.2 at any point on the temperature scale of the thermometer.
5.4 Measurement Retention—A measurement meeting the accuracy requirement of 5.3 will be maintained for a minimum of 20
s when tested in accordance with 6.2.4.
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 June 1, 2010Oct. 1, 2016. Published June 2010October 2016. Originally approved in 1989. Last previous edition approved in 20022010 as
E1299 – 96 (2002).(2010). DOI: 10.1520/E1299-96R10.10.1520/E1299-96R16.
2
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.
3
Available from U.S. Government Printing Office Superintendent of Documents, 732 N. Capitol St., NW, Mail Stop: SDE, Washington, DC 20401, http://
www.access.gpo.gov.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
E1299 − 96 (2016)
TABLE 1 Maximum Error of Temperature Readings
Celsius Scale
Temperature Range, °C Maximum Error, °C
Below 35.8 ±0.3
35.8 to 36.9 ±0.2
37.0 to 39.0 ±0.1
39.1 to 40.4 ±0.2
Fahrenheit Scale
Temperature Range, °F Maximum Error, °F
Below 98.0 ±0.4
98.0 to 102.0 ±0.2
Above 102.0 ±0.4
5.5 Operating Environment—When used in an environment in which the temperature is in the range of 18 to 33 °C (64 to 92
°F), the thermometers, when tested in accordance with 6.3, shall meet the requirements of 5.3 and 5.4.
5.6 Graduation—The thermometer shall be graduated in intervals no greater than 0.1 °C (0.2 °F). As a minimum, appropriate
numerals shall be placed at every half degree graduation for Celsius scale thermometers and every degree graduation for Fahrenheit
scale thermometers.
5.7 Stability—Thermometers shall meet all requirements of this specification over their minimum shelf life of three years.
5.8 Storage Environment—When tested in accordance with 6.4, thermometers shall meet the requirements of 5.3 after having
been stored in an en
...