ASTM_E_1104_-_98_2016.pdf

Designation:E110498(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 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 all single-use clinical ther-mometer probe covers and sheaths intended for use with anyclinical 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 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 required in 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 Patient 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 thermometer 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 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 islogically 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.4.2 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 sheaththat 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 prescribed 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 compatible 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.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.1,2016.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 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 4.6.2 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 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 temperature-taking d