ASTM E1061-2001(2014) 0979 Standard Specification for Direct-Reading Liquid Crystal Forehead Thermometers《直读式带液晶头温度计的标准规格》.pdf

1、Designation: E1061 01 (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 yea

2、r 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 measur

3、ehuman 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 precautio

4、nary 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 practi

5、ces 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 T

6、erms 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:CG 5 MG 5SG1SB25 T520See 3.2.5.2 for description of T520.3.2.2 color play, nthe predictable sequence of colorsexhibi

7、ted 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 identi

8、fiedamount 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 with

9、in 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 temperatu

10、re 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

11、 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 f

12、irst 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 spe

13、cificcolor 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

14、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, w

15、ww.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 States14. R

16、equirements4.1 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

17、.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 SequencingThermal profil

18、es of the liquid crystal for-mulations must be such that: (1) no two readouts are the samecolor within the temperature range of red start to blue start atthe same time; and (2) within the temperature range of thedevice, color must be visible in at least one graphical repre-sentation at all times.4.5

19、 Environment:4.5.1 Operating EnvironmentLiquid crystal forehead ther-mometers shall meet all requirements of this standard whenoperated in an environment of 16 to 40 C (60 to 104 F) anda relative humidity of 15 to 95 %.4.5.2 Storage EnvironmentLiquid crystal forehead ther-mometers shall meet all req

20、uirements of this standard afterhaving been stored or transported, or both, in the dark, at anypoint in an environment of 5 to 65 C (41 to 149 F), and at arelative humidity of 15 to 95 %, for a period of 1 month.4.6 Labeling:4.6.1 The following labeling requirements are the minimumstatements that sh

21、all appear on every label.4.6.2 A statement advising the user that the informationobtained with a liquid crystal forehead thermometer is differentfrom, and will not necessarily give the same readings as, anoral or rectal thermometer.4.6.3 A statement giving the accuracy of the thermometer.4.6.4 A st

22、atement explaining any environmental or physicalfactors which may affect either the readings obtained or theshelf life of the thermometer.4.6.5 A statement explaining the proper placement and theuse of the thermometer, as well as the specific meaning of anynumerals, symbols, or colors which may be o

23、bserved.4.6.6 A statement advising the user that any unusual liquidcrystal forehead thermometer readings should be verified.4.6.7 IdentificationIn order that purchasers may identifyproducts conforming to all requirements of this specification,producers and distributors may include a statement of com

24、pli-ance in conjunction with their name and address on productlabels, invoices, sales literature and the like. The followingstatement is suggested when sufficient space is available: “Thisthermometer conforms to all of the requirements established inthis specification. Full responsibility for the co

25、nformance ofthis product to the specification is assumed by (name andaddress of producer or distributor).” The following abbreviatedstatement is suggested when available space is insufficient forthe full statement: “Conforms to ASTM E1061 (name andaddress of producer or distributor).”5. Test Methods

26、5.1 GeneralThe inspections and test procedures containedin this section are to be used to determine the conformance ofLiquid Crystal Forehead Thermometers to the requirements ofthis specification. Each producer or distributor who representshis products as conforming to this specification may usestat

27、istically based sampling plans that are appropriate for eachparticular manufacturing process but shall keep such essentialrecords as are necessary to document his claim that all of therequirements of this specification are met.5.2 Test Method for Measuring the Thermal Profile of aLiquid Crystal Fore

28、head Thermometer:5.2.1 Place the test sample in a temperature-controlledcirculating water bath fitted with a thermometer traceable toNBS reference standards and accurate to 60.1 C. Means shallbe supplied to heat and cool the circulating water in the bath.The uniformity of temperature of the water wi

29、thin the bathshall be within 60.2 C in the test region.5.2.2 Mount the test sample, if necessary, in a water-proofsample holder.5.2.3 Immerse the test sample and its holder in the bath andhold the test sample parallel to a flat surface of the bath or thewater surface.5.2.4 Place a white light source

30、, having a flat spectraloutput, perpendicular to the flat surface of the test sample sothat the sample colors may be viewed from a directionperpendicular to the flat surface of the test sample.5.2.5 The rate of temperature rise of the water in the bathshould be less than 0.5 C/min.5.2.6 Read for eac

31、h formulation in the thermometer thetemperature of VS, SR, SG, and SB at the defined wavelengthsof light (3.2.1) by visual color comparison to referencestandard narrow bandpass filters, or the temperature of thephotometrically determined maximum reflection (3.2.2) for red- 650 nm, green - 520 nm, or

32、 blue - 470 nm light.5.3 When tested in accordance with these procedures, eachliquid crystal forehead thermometer shall meet the require-ments of 4.2 4.4.5.4 At the completion of the time period and conditionsrecommended by the manufacturer, or as specified in 4.5, theliquid crystal forehead thermom

33、eter shall meet the require-ments of 4.3 and 4.4 when tested according to the proceduresof 4.2.E1061 01 (2014)2ASTM International takes no position respecting the validity of any patent rights asserted in connection with any item mentionedin this standard. Users of this standard are expressly advise

34、d that determination of the validity of any such patent rights, and the riskof infringement of such rights, are entirely their own responsibility.This standard is subject to revision at any time by the responsible technical committee and must be reviewed every five years andif not revised, either re

35、approved or withdrawn. Your comments are invited either for revision of this standard or for additional standardsand should be addressed to ASTM International Headquarters. Your comments will receive careful consideration at a meeting of theresponsible technical committee, which you may attend. If y

36、ou feel that your comments have not received a fair hearing you shouldmake your views known to the ASTM Committee on Standards, at the address shown below.This standard is copyrighted by ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959,United States. Individua

37、l reprints (single or multiple copies) of this standard may be obtained by contacting ASTM at the aboveaddress or at 610-832-9585 (phone), 610-832-9555 (fax), or serviceastm.org (e-mail); or through the ASTM website(www.astm.org). Permission rights to photocopy the standard may also be secured from the Copyright Clearance Center, 222Rosewood Drive, Danvers, MA 01923, Tel: (978) 646-2600; http:/ 01 (2014)3