ASTM E1104-98(2009)
(Specification)Standard Specification for Clinical Thermometer Probe Covers and Sheaths
Standard Specification for Clinical Thermometer Probe Covers and Sheaths
ABSTRACT
This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used are provided. Toxicity test, leakage test, and compatibility test shall be performed to meet the requirements prescribed.
SCOPE
1.1 This specification covers all single-use clinical thermometer probe covers and sheaths intended for use with any clinical thermometer. Requirements are given for safety, toxicity, handling, labeling, and physical integrity. Testing procedures for appropriate requirements and a glossary of terms used within the standards are provided.
1.2 The requirements contained herein are intended to ensure adequate isolation of the patient from the temperature-measuring device. In addition, the safety and health of the patient shall not be adversely affected. When used in accordance with the manufacturers instructions, the probe cover, sheath, and temperature measuring device shall remit correct temperature readings as required in Specifications E 667 and E 1112.
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Standards Content (Sample)
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Designation:E1104 −98(Reapproved 2009)
Standard Specification for
Clinical Thermometer Probe Covers and Sheaths
This standard is issued under the fixed designation E1104; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2.2 patient, n—any human whose temperature is being
taken.
1.1 This specification covers all single-use clinical ther-
mometer probe covers and sheaths intended for use with any
3.2.3 probe, n—an assembly including the transducer that is
clinical thermometer. Requirements are given for safety,
used to position the transducer in the specific location from
toxicity, handling, labeling, and physical integrity. Testing
which the temperature is to be determined.
procedures for appropriate requirements and a glossary of
3.2.4 probe covers and sheaths, n—devicesprovidedforthe
terms used within the standards are provided.
purpose of preventing biological contact between the patient
1.2 The requirements contained herein are intended to
and the probe or clinical thermometer.
ensure adequate isolation of the patient from the temperature-
3.2.5 suitable packaging unit, n—the unit(s) of packaging
measuring device. In addition, the safety and health of the
for which a specific requirement of marking and labeling is
patient shall not be adversely affected. When used in accor-
logically applicable. It shall not be less than the smallest unit
dance with the manufacturers instructions, the probe cover,
intended for sale by the manufacturer or distributor to the final
sheath, and temperature measuring device shall remit correct
user.
temperature readings as required in Specifications E667 and
E1112.
4. Requirements
2. Referenced Documents
4.1 General—Clinical thermometer probe covers and
sheaths represented as complying with this specification shall
2.1 ASTM Standards:
meet all of the requirements specified herein.
E344Terminology Relating to Thermometry and Hydrom-
etry
4.2 Product Safety—Sheaths and probe covers shall be
E667Specification for Mercury-in-Glass, Maximum Self-
constructedtoprecludesharppointsandedgesthatcouldcause
Registering Clinical Thermometers
patient injury. Probe covers and sheaths shall be constructed in
E1112Specification for Electronic Thermometer for Inter-
such a way that the person using them can install and remove
mittent Determination of Patient Temperature
themwithouttouchingthatportionoftheprobecoverorsheath
that comes in contact with the patient.
3. Terminology
4.3 Physical Integrity—The clinical thermometer probe
3.1 Definitions—ThedefinitionsgiveninTerminologyE344
covers and sheaths shall be constructed and packaged so that
shall apply to this Specification with the following additions:
the physical integrity of the probe covers and sheaths will be
3.2 Definitions of Terms Specific to This Standard:
maintained when applied to, used, and removed from a
3.2.1 measurement time, n—time required from time of
temperature-taking device as prescribed by the manufacturer
patient contact to the time when the clinical thermometer may
(see 5.3).
beremovedorreadtowithinthestatedaccuracyoftheclinical
4.4 Toxicity—When the probe covers or sheaths are used as
thermometer.
specified by the manufacturers, its parts intended for contact
with anatomical sites during patient use shall be nontoxic (see
5.1).
This specification is under the jurisdiction of ASTM Committee F04 on
Medical and Surgical Materials and Devices and is the direct responsibility of
4.5 Compatibility—The clinical thermometer probe covers
Subcommittee F04.33 on Medical/Surgical Instruments.
Current edition approved May 1, 2009. Published June 2009. Originally
and sheaths shall be compatible with the intended use of the
approved in 1986. Last previous edition approved in 2003 as E1104–1998 (2003).
temperature-taking device (see 5.4.1).
DOI: 10.1520/E1104-98R09.
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
4.6 Labeling:
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
4.6.1 Instructions shall be provided for proper usage of
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. clinical thermometer probe covers or sheaths.
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E1104−98 (2009)
4.6.2 Suitable packaging units of the thermometer sheaths not included. The inspection and test procedures contained in
or probe covers shall bear in legible characters a designation this specification are used to determine the conformance of
(either a serial number or a code) to indicate the specific probe covers or sheaths to the requirements of this specifica-
manufacturing lot in addition to all other applicable labeling. tion. Each producer or distributor representing products as
Suitable packaging units and other labeling shall also bear a conforming to this specification may use statistically based
statement that the thermometer probe covers or sheaths are sampling pl
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