ASTM_E_1061_-_01_2014.pdf

Designation:E106101(Reapproved 2014)Standard Specification forDirect-Reading Liquid Crystal Forehead Thermometers1This standard is issued under the fixed designation E1061;the number immediately following the designation indicates the year oforiginal adoption or,in the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This specification covers direct-reading liquid crystalforehead thermometers designed to monitor trends or measurehuman forehead surface temperatures,or both.1.2 Thermometers covered by this specification are gener-ally available in continuous or intermittent reading modes.Thermometers meeting the requirements specified herein shallbe considered as complying with this specification.1.3 The following precautionary caveat pertains only to thetest method portion,Section 5,of this specification.Thisstandard does not purport to address all of the safety concerns,if any,associated with its use.It is the responsibility of the userof this standard to consult and establish appropriate safety andhealth practices and determine the applicability of regulatorylimitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E344 Terminology Relating to Thermometry and Hydrom-etry3.Terminology3.1 DefinitionsFor definitions of terms used in thisspecification,refer to Terminology E344.3.2 Definitions of Terms Specific to This Standard:3.2.1 center green(CG)or mid green(MG),nthat tem-perature which unifies the visual and instrumental evaluationmethods and is defined by the equation:CG5 MG5SG1SB25 T520See 3.2.5.2 for description of T520.3.2.2 color play,nthe predictable sequence of colorsexhibited by a liquid crystal formulation as it passes through itsactive temperature range.For example,as temperatureincreases,a formulation exhibits successive tan,red,green,andblue colors.3.2.3 manufacturing lot,n(1)in the case of continuousmanufacturing processes,a lot is a specifically identifiedamount produced in a unit of time or quantity in a manner thatassumes its having uniform characteristics and quality withinspecified limits.(2)In the case of batch processes,a lot means a batch orspecifically identified portion of a batch assumed to haveuniform characteristics and quality within specified limits.3.2.4 sequencing,na characteristic whereby the thermalprofiles of the liquid crystal formulations of a given thermom-eter follow each other in an orderly predetermined manner.3.2.5 specific color phenomena,n(using instrumental meth-ods of evaluation):3.2.5.1 bluethat temperature at which the intensity of 470nm light reflected by the liquid crystal is maximum,symbol-ized as T470.3.2.5.2 greenthat temperature at which the intensity of520 nm light reflected by the liquid crystal is maximum,symbolized as T520.3.2.5.3 redthat temperature at which the intensity of 650nm light reflected by the liquid crystal is maximum,symbol-ized as T650.3.2.6 start of blue(SB),nthat temperature at which theliquid crystal first begins to reflect blue light,which is definedas light having a wavelength of 491 nm.3.2.7 start of green(SG),nthat temperature at which theliquid crystal first begins to reflect green light,which is definedas light having a wavelength of 575 nm.3.2.8 start of red(SR),nthat temperature at which theliquid crystal first begins to reflect red light,which is defined aslight having a wavelength of 675 nm.3.2.9 thermal profile,ntemperatures at which specificcolor phenomena occur in a liquid crystal thermometer.3.2.10 visible start(VS),nthat temperature at which theliquid crystal first begins to reflect visible light.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the direct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Oct.1,2014.Published November 2014.Originallyapproved in 1985.Last previous edition approved in 2007 as E1061 01(2007).DOI:10.1520/E1061-01R14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 4.Requirements4.1 GeneralThermometers represented as complying withthis specification shall meet all of the requirements specifiedherein.4.2 Temperature RangeThe liquid crystal forehead ther-mometer shall,as a minimum,meet all requirements of thisspecification over the temperature range of 32.0 to 38.0 C(90to 100 F).Some color must remain visible up to temperaturesof 39.5 C(103 F).4.3 ToleranceWhenever a temperature for a specific colorphenomenon(3.2.1)is measured,the maximum permissibledeviation is 60.6 C(61.0 F),when tested according to 5.2of this standard.4.4 Sequ