1、Designation: E1965 98 (Reapproved 2016)Standard Specification forInfrared Thermometers for Intermittent Determination ofPatient Temperature1This standard is issued under the fixed designation E1965; the number immediately following the designation indicates the year oforiginal adoption or, in the ca
2、se 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. Scope*1.1 This specification covers electronic instruments in-tended for intermittent measuring and
3、 monitoring of patienttemperatures by means of detecting the intensity of thermalradiation between the subject of measurement and the sensor.1.2 The specification addresses assessing subjects bodyinternal temperature through measurement of thermal emissionfrom the ear canal. Performance requirements
4、 for noncontacttemperature measurement of skin are also provided.1.3 The specification sets limits for laboratory accuracy andrequires determination and disclosure of clinical accuracy ofthe covered instruments.1.4 Performance and storage limits under various environ-mental conditions, requirements
5、for labeling and test proce-dures are established.NOTE 1For electrical safety consult Underwriters Laboratory Stan-dards.2NOTE 2For electromagnetic emission requirements and tests refer toCISPR 11: 1990 Lists of Methods of Measurement of ElectromagneticDisturbance Characteristics of Industrial, Scie
6、ntific, and Medical (ISM)Radiofrequency Equipment.31.5 The values of quantities stated in SI units are to beregarded as the standard. The values of quantities in parenthe-ses are not in SI and are optional.1.6 The following precautionary caveat pertains only to thetest method portion, Section 6, of
7、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 establish appropriate safety and healthpractices and determine the applicability of regulatory limita-tions prior to use.2.
8、 Referenced Documents2.1 ASTM Standards:4E177 Practice for Use of the Terms Precision and Bias inASTM Test MethodsE344 Terminology Relating to Thermometry and Hydrom-etryE667 Specification for Mercury-in-Glass, Maximum Self-Registering Clinical ThermometersE1112 Specification for Electronic Thermome
9、ter for Inter-mittent Determination of Patient Temperature2.2 International Electrotechnical Commission Standards:IEC 601-1-2: 1993 Medical Electrical Equipment, Part 1;General Requirements for Safety. Collateral Standard:Electromagnetic CompatibilityRequirements and Tests3IEC 1000-4-2: 1995 Electro
10、magnetic Compatibility(EMC)Part 4: Testing and Measurement Techniques;Section 2: Electrostatic Discharge Immunity Test: BasicEMC Publication (Rev. of IEC 801-2)3IEC 1000-4-3: 1995 Electromagnetic Compatibility32.3 Other Standards:International Vocabulary of Basic and General Terms inMetrology (VIM)3
11、3. Terminology3.1 DefinitionsThe definitions given in Terminology E344apply.3.2 Definitions of Terms Specific to This Standard:3.2.1 The terms defined below are for the purposes of thisspecification only. Manufacturers should use this terminologyin labeling instruments and in technical and sales lit
12、erature.3.2.2 accuracy, nability of an infrared thermometer togive a reading close to the true temperature.3.2.3 adjusted mode, noutput of an IR thermometer thatgives the temperature measured and calculated from a subjector object, by correcting such temperature for variations inambient temperature,
13、 the subjects temperature, emissivity,body site (that is, oral,orrectal), etc.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 approv
14、ed Oct. 1, 2016. Published October 2016. Originallyapproved in 1998. Last previous edition approved in 2009 as E1965 98 (2009).DOI: 10.1520/E1965-98R16.2Available from Underwriters Laboratories (UL), 2600 N.W. Lake Rd., Camas,WA 98607-8542, http:/.3Available from Global Engineering Documents, 15 Inv
15、erness Way East,Englewood, CO 80112.4For 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.*A Summary of Changes sec
16、tion appears at the end of this standardCopyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States13.2.4 axillary temperature tba, ntemperature at the apexof either axilla (armpit) as measured by a contact thermometer.3.2.5 blackbody, na referen
17、ce source of infrared radiationmade in the shape of a cavity and characterized by preciselyknown temperature of the cavity walls and having effectiveemissivity at the cavity opening arbitrarily considered equal tounity.3.2.6 blackbody temperature tBB, ntemperature ofblackbody cavity walls as measure
18、d by an imbedded orimmersed contact thermometer.3.2.7 bladder temperature, ntemperature of the interior ofthe urinary bladder as measured by a contact thermometer.3.2.8 body temperature, ntemperature measured from theinterior of a human body cavity, such as pulmonary artery,distal esophagus, urinary
19、 bladder, ear canal, oral, or rectal.3.2.9 clinical accuracy, nability of an infrared ear canalthermometer to give a reading close to true temperature of thesite that it purports to represent.3.2.10 clinical bias xd, nmean difference between IRthermometer output and an internal body site temperature
20、 fromsubjects at specified conditions of ambient temperature andhumidity and averaged over a selected group of subjects.3.2.11 clinical repeatability sr, npooled standard devia-tion of changes in multiple ear canal temperature readings astaken from the same subject from the same ear with the sameinf
21、rared thermometer by the same operator within a relativelyshort time.3.2.12 combined site offset s, ncalculated difference indegrees of measured temperature between a selected referencebody site and ear canal temperature and averaged over thepopulation of representative study samples.3.2.13 contact
22、thermometer, nan instrument that isadapted for measuring temperature by means of thermalconductivity by determining temperature at the moment whennegligible thermal energy flows between the thermometer andthe object of measurement.3.2.14 core temperature tc, ntemperature at a subjectsbody site, such
23、 as the pulmonary artery, distal esophagus,urinary bladder, or tympanic membrane, recognized as indica-tive of internal body temperature and obtained with a contactthermometer.3.2.15 mode, nan output of an IR thermometer that givesa representation of a temperature using a disclosed calculationtechni
24、que with respect to selected reference (for example,blackbody, oral, rectal, etc.).3.2.16 displayed temperature range, ntemperature rangein degrees Celsius or Fahrenheit that can be shown by an IRthermometer.3.2.17 IR thermometer type, nan optoelectronic instru-ment that is capable of noncontact inf
25、rared temperature mea-surement when placed into the auditory canal of a subject (earcanal type) or from the subjects body surface (skin type).3.2.18 ear canal temperature tec, ndisplayed unadjustedtemperature measured from the field of view of an IR thermom-eter whose probe is placed into the audito
26、ry canal of a subjectaccording to the manufacturers recommendations.3.2.19 field of view, narea of a subjects surface thatexchanges thermal radiation with the sensor.3.2.20 infrared (IR), adjof the electromagnetic radiationwithin the mid- and far infrared spectral ranges (approximatelyfrom 3 to 30 m
27、 wavelength).3.2.21 infrared (IR) thermometer, noptoelectronic instru-ment adapted for noncontact measurement of the temperatureof a subject by utilizing infrared radiation exchange betweenthe subject and the sensor.3.2.22 instrumentational offset d, ncalculated differ-ence in degrees of measured te
28、mperature between core tem-perature and ear canal temperature, derived from the popula-tion of representative study samples.3.2.23 internal, adjof the interior of subjects body orbody cavity, such as pulmonary artery, urinary bladder, oral,rectal, etc.3.2.24 laboratory error , ndifference between un
29、ad-justed temperature as measured by an IR thermometer andtemperature of a blackbody, over specified operating condi-tions of ambient temperature and humidity and blackbodytemperature ranges.3.2.25 operating temperature, nambient temperature thatallows operation of an IR thermometer within specified
30、 labo-ratory error range.3.2.26 operating humidity, nrelative humidity of ambientair which allows operation of an IR thermometer within aspecified laboratory error range.3.2.27 oral temperature tbm, nposterior sublingual tem-perature as measured by a contact thermometer.3.2.28 physiological site off
31、set, p, ndifference in de-grees of measured temperature between two body sites derivedfrom the representative study samples.3.2.29 probe, npart of an IR thermometer that channelsnet infrared radiation between the subject and the sensor and isintended to be positioned near or inside the subject.3.2.3
32、0 probe cover, ndisposable or reusable sanitary bar-rier enveloping that part of the probe which otherwise wouldcome in contact with a subject.3.2.31 professional use, nintended or implied use of aninstrument by individuals that are licensed or certified forcollecting information for medical diagnos
33、ing purposes.3.2.32 rectal temperature tbr, ntemperature in the analcanal as measured by a contact thermometer.3.2.33 resolution, nminimum temperature increment dis-played by an IR thermometer in degrees Celsius or Fahrenheit.3.2.34 scale, ngraduation of temperature display in de-grees Celsius or Fa
34、hrenheit.3.2.35 sensor, ndevice designed to respond to net IRradiation and convert that response into electrical signals.3.2.36 skin temperature, naverage temperature of a flatskin surface as measured from the field of view of an IR skintype thermometer, with an appropriate adjustments for skinemiss
35、ivity.E1965 98 (2016)23.2.37 system, ncombination of an IR thermometer and aninstalled probe cover.3.2.38 subject, na human whose temperature is measured.3.2.39 true temperature, ntemperature attributed to aparticular site of a subject or object of measurement andaccepted as having a specified uncer
36、tainty.3.2.40 tympanic temperature tty, ntemperature of eithertympanic membrane as measured by a contact thermometer.3.2.41 unadjusted mode, nan output of IR thermometerthat displays temperature measured and calculated from asubject or object, without any corrections for variations inoperating tempe
37、rature, subject temperature, emissivity, etc.4. Classification4.1 IR thermometers may be classified into two types: “earcanal IR thermometers” and “skin IR thermometers.”4.1.1 The ear canal IR thermometer is intended for assessingthe internal temperature of a subject.4.1.2 The skin IR thermometer is
38、 intended for assessing theouter surface temperature of a subject.5. Requirements5.1 The following requirements shall apply to any IRthermometer that is labeled to meet these specifications.5.2 Displayed Temperature Range:5.2.1 In any display mode, an ear canal IR thermometershall display a subjects
39、 temperature over a minimum range of34.4 to 42.2 C (94.0 to 108.0 F).5.2.2 A skin IR thermometer shall display a subjectstemperature over a minimum range of 22 to 40.0 C (71.6 to104.0 F).5.3 Maximum Permissible Laboratory Error (for an EarCanal IR Thermometer):5.3.1 Within the manufacturers specifie
40、d operating ambientconditions (see 5.6), laboratory error as measured accordingto 6.1.4 shall be no greater than values specified below:5.3.1.1 For blackbody temperature range from 36 to 39 C(96.8 to 102.2 F)0.2 C (0.4 F).5.3.1.2 For blackbody temperatures less than 36 C (96.8F) or greater than 39 C
41、 (102.2 F)0.3 C (0.5 F).5.4 Maximum Permissible Laboratory Error (for a Skin IRThermometer):5.4.1 Within the manufacturers specified operating ambientconditions (see 5.6) over the display temperature range asspecified in 5.2.2, laboratory error as measured according to6.1.5 shall be no greater than
42、0.3 C (0.5 F).5.5 Special Requirements:5.5.1 Clinical Accuracy:5.5.1.1 The clinical accuracy requirement is applicable onlyto an ear canal IR thermometer system and the correspondingage groups of subjects for which such a thermometer is labeledor implied to be used.5.5.1.2 Clinical accuracy shall be
43、 determined separately foreach of the following conditions: for each device model, foreach adjusted display mode, and for every age group of febrileand afebrile subjects on which the IR thermometer is intendedto be used.5.5.1.3 Any disclosure of clinical accuracy claims shall beaccompanied by disclo
44、sure of methodology and procedures.Such information shall be made available on request.5.5.1.4 Clinical accuracy should be determined in the formof two characteristicsclinical bias with stated uncertainty andclinical repeatability, as defined in 3.2.9.5.6 Ambient Conditions:5.6.1 Operating Temperatu
45、re Range:5.6.1.1 The system shall meet laboratory error requirementsas specified in 5.3 or 5.4, or both, when operating in anenvironment from 16 to 40 C (60.8 to 104.0 F).5.6.1.2 If the operating temperature range is narrower thanspecified in 5.6.1.1, the device shall be clearly labeled with acautio
46、nary statement of the maximum or minimum operatingtemperatures, or both.5.6.1.3 Under no circumstances may the upper limit ofoperating temperature range be less than 35 C (95 F).5.6.2 Operating Humidity RangeThe relative humidityrange for the operating temperature range as specified in 5.6.1is up to
47、 95 %, noncondensing.5.6.3 Shock:5.6.3.1 The instrument with batteries installed (if appli-cable) without a carrying (storage) casing shall withstand dropswith controlled orientation of the device without degradation ofaccuracy as specified in 5.3 or 5.4, or both, for a blackbodytemperature of or ne
48、ar 37 C (98.6 F), when tested accordingto 6.3.5.6.3.2 If an IR thermometer does not meet the requirementof 5.6.3.1, a means of detecting and informing the user of itsinoperable state, after being subjected to shock, shall beprovided.5.6.4 Storage ConditionsThe instrument shall meet theaccuracy requi
49、rements of 5.3 or 5.4, or both, after having beenstored or transported, or both, at any point in an environmentof 20 to + 50 C ( 4 to + 122 F) and relative humidity upto 95 %, noncondensing, for a period of one month. The testprocedure is specified in 6.1.6.5.6.5 Cleaning and DisinfectionInstrument performanceshall not be degraded by using the manufacturers recom-mended procedures for cleaning and disinfection provided inthe instruction manual. Suc
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