ASTM E1061-01(2014)

Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers

ABSTRACT
This specification covers the requirements and test methods for direct-reading liquid crystal forehead thermometers, in either the continuous or intermittent reading modes, designed to monitor trends or measure human forehead surface temperatures, or both. When examined by test methods recommended herein, each thermometer shall comply with thermal profile, temperature range, tolerance, sequencing, operating and storage environment, and labeling requirements.
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.

General Information

• Status: Historical
• Publication Date: 30-Sep-2014
• 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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E1061 −01 (Reapproved 2014)
Standard Specification for
Direct-Reading Liquid Crystal Forehead Thermometers
This standard is issued under the fixed designation E1061; 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 3.2.2 color play, n—the predictable sequence of colors
exhibitedbyaliquidcrystalformulationasitpassesthroughits
1.1 This specification covers direct-reading liquid crystal
active temperature range. For example, as temperature
forehead thermometers designed to monitor trends or measure
increases,aformulationexhibitssuccessivetan,red,green,and
human forehead surface temperatures, or both.
blue colors.
1.2 Thermometers covered by this specification are gener-
3.2.3 manufacturing lot, n—(1) in the case of continuous
ally available in continuous or intermittent reading modes.
manufacturing processes, a lot is a specifically identified
Thermometers meeting the requirements specified herein shall
amount produced in a unit of time or quantity in a manner that
be considered as complying with this specification.
assumes its having uniform characteristics and quality within
1.3 The following precautionary caveat pertains only to the
specified limits.
test method portion, Section 5, of this specification.This
(2) In the case of batch processes, a lot means a batch or
standard does not purport to address all of the safety concerns,
specifically identified portion of a batch assumed to have
if any, associated with its use. It is the responsibility of the user
uniform characteristics and quality within specified limits.
of this standard to consult and establish appropriate safety and
health practices and determine the applicability of regulatory
3.2.4 sequencing, n—a characteristic whereby the thermal
limitations prior to use.
profiles of the liquid crystal formulations of a given thermom-
eter follow each other in an orderly predetermined manner.
2. Referenced Documents
3.2.5 specific color phenomena, n (using instrumental meth-
2.1 ASTM Standards:
ods of evaluation):
E344 Terminology Relating to Thermometry and Hydrom-
3.2.5.1 blue—that temperature at which the intensity of 470
etry
nm light reflected by the liquid crystal is maximum, symbol-
ized as T°470.
3. Terminology
3.2.5.2 green—that temperature at which the intensity of
3.1 Definitions—For definitions of terms used in this
520 nm light reflected by the liquid crystal is maximum,
specification, refer to Terminology E344.
symbolized as T°520.
3.2 Definitions of Terms Specific to This Standard:
3.2.5.3 red—that temperature at which the intensity of 650
3.2.1 center green (CG) or mid green (MG), n—that tem-
nm light reflected by the liquid crystal is maximum, symbol-
perature which unifies the visual and instrumental evaluation
ized as T°650.
methods and is defined by the equation:
3.2.6 start of blue (SB), n—that temperature at which the
SG1SB
liquid crystal first begins to reflect blue light, which is defined
CG 5 MG 5 5 T°520
as light having a wavelength of 491 nm.
See 3.2.5.2 for description of T°520.
3.2.7 start of green (SG), n—that temperature at which the
liquid crystal first begins to reflect green light, which is defined
as light having a wavelength of 575 nm.
This specification is under the jurisdiction of ASTM Committee F04 on
3.2.8 start of red (SR), n—that temperature at which the
Medical and Surgical Materials and Devices and is the direct responsibility of
liquidcrystalfirstbeginstoreflectredlight,whichisdefinedas
Subcommittee F04.33 on Medical/Surgical Instruments.
light having a wavelength of 675 nm.
Current edition approved Oct. 1, 2014. Published November 2014. Originally
approved in 1985. Last previous edition approved in 2007 as E1061 – 01(2007).
3.2.9 thermal profile, n—temperatures at which specific
DOI: 10.1520/E1061-01R14.
color phenomena occur in a liquid crystal thermometer.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
3.2.10 visible start (VS), n—that temperature at which the
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. liquid crystal first begins to reflect visible light.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1061 − 01 (2014)
4. Requirements statement is suggested when sufficient space is available: “This
thermometer conforms to all of the requirements established in
4.1 General—Thermometers represented as complying with
this specification. Full responsibility for the conformance of
this specification shall meet all of the requirements specified
this product to the specification is assumed by (name and
herein.
address of producer or distributor).”The following abbreviated
4.2 Temperature Range—The liquid crystal forehead ther-
statement is suggested when available space is insufficient for
mometer shall, as a minimum, meet all requirements of this
the full statement: “Conforms to ASTM E1061 (name and
specification over the temperature range of 32.0 to 38.0 °C (90
address of producer or distributor).”
to 100 °F). Some color must remain visible up to temperatures
5. Test Methods
of 39.5 °C (103 °F).
5.1 General—Theinspectionsandtestprocedurescontained
4.3 Tolerance—Whenever a temperature for a specific color
in this section are to be used to determine the conformance of
phenomen
...

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: E1061 − 01 (Reapproved 2007) E1061 − 01 (Reapproved 2014)
Standard Specification for
Direct-Reading Liquid Crystal Forehead Thermometers
This standard is issued under the fixed designation E1061; 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 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.
2. Referenced Documents
2.1 ASTM Standards:
E344 Terminology Relating to Thermometry and Hydrometry
3. Terminology
3.1 Definitions—For definitions of terms used in this specification, refer to Terminology E344.
3.2 Definitions of Terms Specific to This Standard:
3.2.1 center green (CG) or mid green (MG), n—that temperature which unifies the visual and instrumental evaluation methods
and is defined by the equation:
SG1SB
CG 5 MG 5 5 T°520
See 3.2.5.2 for description of T°520.
3.2.2 color play, n—the predictable sequence of colors exhibited by a liquid crystal formulation as it passes through its active
temperature range. For example, as temperature increases, a formulation exhibits successive tan, red, green, and blue colors.
3.2.3 manufacturing lot, n—(1) in the case of continuous manufacturing processes, a lot is a specifically identified amount
produced in a unit of time or quantity in a manner that assumes its having uniform characteristics and quality within specified
limits.
(2) In the case of batch processes, a lot means a batch or specifically identified portion of a batch assumed to have uniform
characteristics and quality within specified limits.
3.2.4 sequencing, n—a characteristic whereby the thermal profiles of the liquid crystal formulations of a given thermometer
follow each other in an orderly predetermined manner.
3.2.5 specific color phenomena, n (using instrumental methods of evaluation):
3.2.5.1 blue—that temperature at which the intensity of 470 nm light reflected by the liquid crystal is maximum, symbolized
as T°470.
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, 2007Oct. 1, 2014. Published June 2007November 2014. Originally approved in 1985. Last previous edition approved in 20012007 as
E1061 – 01.E1061 – 01(2007). DOI: 10.1520/E1061-01R07.10.1520/E1061-01R14.
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’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1061 − 01 (2014)
3.2.5.2 green—that temperature at which the intensity of 520 nm light reflected by the liquid crystal is maximum, symbolized
as T°520.
3.2.5.3 red—that temperature at which the intensity of 650 nm light reflected by the liquid crystal is maximum, symbolized as
T°650.
3.2.6 start of blue (SB), n—that temperature at which the liquid crystal first begins to reflect blue light, which is defined as light
having a wavelength of 491 nm.
3.2.7 start of green (SG), n—that temperature at which the liquid crystal first begins to reflect green light, which is defined as
light having a wavelength of 575 nm.
3.2.8 start of red (SR), n—that temperature at which the liquid crystal first begins to reflect red light, which is defined as light
having a wavelength of 675 nm.
3.2.9 thermal profile, n—temperatures at which specific color phenomena occur in a liquid crystal thermometer.
3.2.10 visible start (VS), n—that temperature at which the liquid crystal first begins to reflect visible light.
4. Requirements
4.1 General—Thermometers represented as complying with this specification shall meet all of the requirements specified herein.
4.2 Temperature Range—The liquid crystal forehead thermometer shall, as a minimum, meet all requirements of this
specification over the temperature range of 32.0 to 38.0 °C (90 to 100 °F). Some color must remain visible up to temperatures of
39.5 °C (103 °F).
4.3 Tolerance—Whenever a temperature for a specific color phenomenon (3.2.1) is measured, the maximum permissible
deviation is 60.6 °C (61.0 °F), when tested according to 5.2 of this standard.
4.4 Sequencing—Thermal profiles of the liquid crystal formulations must be such that: (1) no two readouts are the same color
within the temperature range of red start to blue start at the same time; and (2) within the temperature range of the device, color
must be visible in at least one graphi
...