ASTM E1104-1998(2003) Standard Specification for Clinical Thermometer Probe Covers and Sheaths《医用温度计测头罩和护壳标准规范》.pdf

1、Designation: E 1104 98 (Reapproved 2003)Standard Specification forClinical Thermometer Probe Covers and Sheaths1This standard is issued under the fixed designation E 1104; the number immediately following the designation indicates the year oforiginal adoption or, in the case of revision, the year of

2、 last revision. A number in parentheses indicates the year of last reapproval. Asuperscript epsilon (e) 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 anycli

3、nical thermometer. Requirements are given for safety, tox-icity, handling, labeling, and physical integrity. Testing proce-dures for appropriate requirements and a glossary of terms usedwithin the standards are provided.1.2 The requirements contained herein are intended toensure adequate isolation o

4、f the patient 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 req

5、uired in Specifications E 667 andE 1112.2. Referenced Documents2.1 ASTM Standards:E 344 Terminology Relating to Thermometry and Hydrom-etry2E 667 Specification for Mercury-in-Glass Maximum Self-Registering Clinical Thermometers2E 1112 Specification for Electronic Thermometers for Inter-mittent Deter

6、mination of Patient Temperature23. Terminology3.1 DefinitionsThe definitions given in TerminologyE 344 shall apply to this Specification with the followingadditions:3.2 Definitions of Terms Specific to This Standard:3.2.1 measurement time, ntime required from time ofpatient contact to the time when

7、the clinical thermometer maybe removed or read to within the 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 temperatu

8、re is to be determined.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 islogical

9、ly applicable. 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

10、.2 Product SafetySheaths 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 sheath

11、that comes in 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 prescr

12、ibed by the manufacturer(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 compa

13、tible with the 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.4.6.2 Suitable packaging units of the thermometer sheathsor probe covers shall bear in legible characters a design

14、ation(either a serial number or a code) to indicate the specificmanufacturing lot in addition to all other applicable labeling.1This specification is under the jurisdiction of ASTM Committee E20 onTemperature Measurement and is the direct responsibility of Subcommittee E20.08on Medical Thermometry.C

15、urrent edition approved May 10, 2003. Published July 2003. Originallyapproved in 1986. Last previous edition approved in 1998 as E 1104 1998.2Annual Book of ASTM Standards, Vol 14.03.1Copyright ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.Su

16、itable packaging units and other labeling shall also bear 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 temperatu

17、re-taking devices performance andoperating characteristics, such as measurement time or accu-racy, are adversely affected by the probe cover or sheath, theconsequence to the devices performance characteristics mustbe specified (see 5.4).4.6.5 Probe covers and sheaths may fail to isolate the patientf

18、rom the temperature measuring device shall contain a cautionstatement. 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 re

19、quirements of this specification, producers anddistributors 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

20、 the requirements established in ASTM Standard E 1104.Full responsibility 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: “Confo

21、rms toASTM Standard E 1104 (name and address of producer ordistributor).”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 fo

22、r 1 month (non-condensing).4.7.3 Use EnvironmentBody conditions (oral or rectal).5. Testing Procedures5.1 Significance and UseThis section describes the pro-cedures necessary to verify conformance to certain require-ments of Section 4. Procedures that can be verified byobservation are not included.

23、The inspection and test proce-dures contained in this specification are used to determine theconformance of probe covers or sheaths to the requirements ofthis specification. Each producer or distributor representingproducts as conforming to this specification may use statisti-cally based sampling pl

24、ans that are appropriate for eachparticular manufacturing process, but shall keep the essentialrecords necessary to document the claim that all of therequirements of this specification are met.5.2 Toxicity TestTest materials intended for patient con-tact shall be in accordance with the current issue

25、 of USPBiological Test-Plastic Container, Table 1: Extract of sample insodium chloride 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

26、 instructions, apply air at a positive internal gage pressureof 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.T

27、hermometer probe covers and sheaths that are intended toinvert when 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 reco

28、mmended shall be tested to verify that itmeets the device manufacturers 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 AST

29、M standards for the particulartemperature-taking device (for example, Specifications E 667and E 1112).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

30、.1 clinical; probe covers; sheaths; thermometerASTM 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 determination of the validity of any such patent rights,

31、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 reapproved or withdrawn. Your comments are invited either for revi

32、sion 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 you feel that your comments have not received a fair hearing you

33、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 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).3Available from United States Pharmacopeial Convention Inc., 12601 Twin-brook Parkway, Rockway, MD 20852.E 1104 98 (2003)2