1、Designation: E1104 98 (Reapproved 2016)Standard Specification forClinical Thermometer Probe Covers and Sheaths1This standard is issued under the fixed designation E1104; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of l
2、ast 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 all single-use clinical ther-mometer probe covers and sheaths intended for use with anyclinic
3、al thermometer. Requirements are given for safety,toxicity, handling, labeling, and physical integrity. Testingprocedures for appropriate requirements and a glossary ofterms used within the standards are provided.1.2 The requirements contained herein are intended toensure adequate isolation of the p
4、atient from the temperature-measuring device. In addition, the safety and health of thepatient shall not be adversely affected. When used in accor-dance with the manufacturers instructions, the probe cover,sheath, and temperature measuring device shall remit correcttemperature readings as required i
5、n Specifications E667 andE1112.2. Referenced Documents2.1 ASTM Standards:2E344 Terminology Relating to Thermometry and Hydrom-etryE667 Specification for Mercury-in-Glass, Maximum Self-Registering Clinical ThermometersE1112 Specification for Electronic Thermometer for Inter-mittent Determination of P
6、atient Temperature3. Terminology3.1 DefinitionsThe definitions given in Terminology E344shall apply to this Specification with the following additions:3.2 Definitions of Terms Specific to This Standard:3.2.1 measurement time, ntime required from time ofpatient contact to the time when the clinical t
7、hermometer maybe removed or read to within its stated accuracy of the clinicalthermometer.3.2.2 patient, nany human whose temperature is beingtaken.3.2.3 probe, nan assembly including the transducer that isused to position the transducer in the specific location fromwhich the temperature is to be de
8、termined.3.2.4 probe covers and sheaths, ndevices provided for thepurpose of preventing biological contact between the patientand the probe or clinical thermometer.3.2.5 suitable packaging unit, nthe unit(s) of packagingfor which a specific requirement of marking and labeling islogically applicable.
9、 It shall not be less than the smallest unitintended for sale by the manufacturer or distributor to the finaluser.4. Requirements4.1 GeneralClinical thermometer probe covers andsheaths represented as complying with this specification shallmeet all of the requirements specified herein.4.2 Product Saf
10、etySheaths and probe covers shall beconstructed to preclude sharp points and edges that could causepatient injury. Probe covers and sheaths shall be constructed insuch a way that the person using them can install and removethem without touching that portion of the probe cover or sheaththat comes in
11、contact with the patient.4.3 Physical IntegrityThe clinical thermometer probecovers and sheaths shall be constructed and packaged so thatthe physical integrity of the probe covers and sheaths will bemaintained when applied to, used, and removed from atemperature-taking device as prescribed by the ma
12、nufacturer(see 5.3).4.4 ToxicityWhen the probe covers or sheaths are used asspecified by the manufacturers, its parts intended for contactwith anatomical sites during patient use shall be nontoxic (see5.1).4.5 CompatibilityThe clinical thermometer probe coversand sheaths shall be compatible with the
13、 intended use of thetemperature-taking device (see 5.4.1).4.6 Labeling:4.6.1 Instructions shall be provided for proper usage ofclinical thermometer probe covers or sheaths.1This specification is under the jurisdiction of ASTM Committee F04 onMedical and Surgical Materials and Devices and is the dire
14、ct responsibility ofSubcommittee F04.33 on Medical/Surgical Instruments.Current edition approved Oct. 1, 2016. Published October 2016. Originallyapproved in 1986. Last previous edition approved in 2009 as E1104 1998 (2009).DOI: 10.1520/E1104-98R16.2For referenced ASTM standards, visit the ASTM websi
15、te, 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 States
16、14.6.2 Suitable packaging units of the thermometer sheathsor probe covers shall bear in legible characters a designation(either a serial number or a code) to indicate the specificmanufacturing lot in addition to all other applicable labeling.Suitable packaging units and other labeling shall also bea
17、r astatement that the thermometer probe covers or sheaths areintended for single use only.4.6.3 The temperature-taking device for which the clinicalthermometer probe cover or sheath is or is not intended shall bespecified.4.6.4 If the temperature-taking devices performance andoperating characteristi
18、cs, such as measurement time oraccuracy, are adversely affected by the probe cover or sheath,the consequence to the devices performance characteristicsmust be specified (see 5.4).4.6.5 Probe covers and sheaths may fail to isolate the patientfrom the temperature measuring device shall contain a cauti
19、onstatement. Susceptibility to failure of probe covers or sheathsshall be determined by appropriate testing by each manufac-turer or distributor.4.6.6 Identification:4.6.6.1 In order that purchasers may identify products con-forming to all requirements of this specification, producers anddistributor
20、s may include a statement of compliance in conjunc-tion with their name and address on product labels, invoices,sales literature, etc. The following statement is suggested whensufficient space is available: “This thermometer conforms to allof the requirements established inASTM Standard E1104. Fullr
21、esponsibility for the conformance of this product to thespecification is assumed by (name and address of producer ordistributor).”4.6.6.2 The following abbreviated statement is suggestedwhen available space on labels is insufficient: “Conforms toASTM Standard E1104 (name and address of producer ordi
22、stributor).”4.7 Use, Operating, and Storage Environment Conditions:4.7.1 Operating Environment16.0 C (60.8 F) to 40.0 C(104.0 F), 15 % to 95 % RH (non-condensing).4.7.2 Storage Environment, 20.0 C (4 F) to 49.0 C(120.2 F) 15 % to 95 % RH for 1 month (non-condensing).4.7.3 Use EnvironmentBody conditi
23、ons (oral or rectal).5. Testing Procedures5.1 Significance and UseThis section describes the proce-dures necessary to verify conformance to certain requirementsof Section 4. Procedures that can be verified by observation arenot included. The inspection and test procedures contained inthis specificat
24、ion are used to determine the conformance ofprobe covers or sheaths to the requirements of this specifica-tion. Each producer or distributor representing products asconforming to this specification may use statistically basedsampling plans that are appropriate for each particular manu-facturing proc
25、ess, but shall keep the essential records necessaryto document the claim that all of the requirements of thisspecification are met.5.2 Toxicity TestTest materials intended for patient contactshall be in accordance with the current issue of USP BiologicalTest-Plastic Container, Table 1: Extract of sa
26、mple in sodiumchloride and extract of sample in vegetable oil.35.3 Leakage TestAfter placement and removal of theclinical thermometer probe cover or sheath onto and from thetemperature taking device in accordance with the manufactur-ers instructions, apply air at a positive internal gage pressureof
27、8.4 kPa (1.2 psi) with the probe cover or sheath submergedin water within the operating temperature environment (See4.7) to the length that is intended for patient contact. Thereshall be no continuous bubble stream observed within 5 s.Thermometer probe covers and sheaths that are intended toinvert w
28、hen the temperature-taking device is withdrawn maybe tested while inverted.5.4 Compatibility Test:5.4.1 The compatibility of the clinical thermometer probecover or sheath with any particular temperature-taking devicefor which it is recommended shall be tested to verify that itmeets the device manufa
29、cturers performance characteristics.5.4.2 A probe cover or sheath shall not degrade the perfor-mance (such as measurement time or accuracy) of thetemperature-taking device so that it fails to meet the require-ments of the applicable ASTM standards for the particulartemperature-taking device (for exa
30、mple, Specifications E667and E1112).5.5 Storage EnvironmentAt the completion of the timeperiod and conditions listed in 4.7 (storage environment), theprobe covers and sheaths shall pass all the test procedures ofSection 5.6. Keywords6.1 clinical; probe covers; sheaths; thermometer3Available from Uni
31、ted States Pharmacopeial Convention Inc., 12601 Twin-brook Parkway, Rockway, MD 20852.E1104 98 (2016)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 advised that de
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34、hat 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. Individual reprint
35、s (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:/ 98 (2016)3
