ASTM E1104-98(2003)

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.

General Information

• Status: Historical
• Publication Date: 09-May-2003
• ICS: 11.040.99 - Other medical equipment
• ICS: 17.200.20 - Temperature-measuring instruments
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.33 - Medical/Surgical Instruments

Relations

• Replaces: ASTM E1104-98 - Standard Specification for Clinical Thermometers Probe Covers and Sheaths
• Effective Date: 10-May-2003
• Replaced By: ASTM E1104-98(2009) - Standard Specification for Clinical Thermometer Probe Covers and Sheaths
• Effective Date: 01-May-2009
• Referred By: ASTM E1112-00(2018) - Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
• Effective Date: 10-May-2003
• Referred By: ASTM E344-20 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 10-May-2003

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation: E 1104 – 98 (Reapproved 2003)
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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2.3 probe, n—anassemblyincludingthetransducerthatis
used to position the transducer in the specific location from
1.1 This specification covers all single-use clinical ther-
which the temperature is to be determined.
mometer probe covers and sheaths intended for use with any
3.2.4 probe covers and sheaths, n—devicesprovidedforthe
clinical thermometer. Requirements are given for safety, tox-
purpose of preventing biological contact between the patient
icity, handling, labeling, and physical integrity. Testing proce-
and the probe or clinical thermometer.
duresforappropriaterequirementsandaglossaryoftermsused
3.2.5 suitable packaging unit, n—the unit(s) of packaging
within the standards are provided.
for which a specific requirement of marking and labeling is
1.2 The requirements contained herein are intended to
logically applicable. It shall not be less than the smallest unit
ensure adequate isolation of the patient from the temperature-
intended for sale by the manufacturer or distributor to the final
measuring device. In addition, the safety and health of the
user.
patient shall not be adversely affected. When used in accor-
dance with the manufacturers instructions, the probe cover,
4. Requirements
sheath, and temperature measuring device shall remit correct
4.1 General—Clinical thermometer probe covers and
temperature readings as required in Specifications E667 and
sheaths represented as complying with this specification shall
E1112.
meet all of the requirements specified herein.
2. Referenced Documents 4.2 Product Safety—Sheaths and probe covers shall be
constructedtoprecludesharppointsandedgesthatcouldcause
2.1 ASTM Standards:
patient injury. Probe covers and sheaths shall be constructed in
E344 Terminology Relating to Thermometry and Hydrom-
such a way that the person using them can install and remove
etry
themwithouttouchingthatportionoftheprobecoverorsheath
E667 Specification for Mercury-in-Glass Maximum Self-
2 that comes in contact with the patient.
Registering Clinical Thermometers
4.3 Physical Integrity—The clinical thermometer probe
E1112 SpecificationforElectronicThermometersforInter-
2 covers and sheaths shall be constructed and packaged so that
mittent Determination of Patient Temperature
the physical integrity of the probe covers and sheaths will be
3. Terminology maintained when applied to, used, and removed from a
temperature-taking device as prescribed by the manufacturer
3.1 Definitions—The definitions given in Terminology
(see 5.3).
E344 shall apply to this Specification with the following
4.4 Toxicity—When the probe covers or sheaths are used as
additions:
specified by the manufacturers, its parts intended for contact
3.2 Definitions of Terms Specific to This Standard:
with anatomical sites during patient use shall be nontoxic (see
3.2.1 measurement time, n—time required from time of
5.1).
patient contact to the time when the clinical thermometer may
4.5 Compatibility—The clinical thermometer probe covers
beremovedorreadtowithinthestatedaccuracyoftheclinical
and sheaths shall be compatible with the intended use of the
thermometer.
temperature-taking device (see 5.4.1).
3.2.2 patient, n—any human whose temperature is being
4.6 Labeling:
taken.
4.6.1 Instructions shall be provided for proper usage of
clinical thermometer probe covers or sheaths.
This specification is under the jurisdiction of ASTM Committee E20 on
4.6.2 Suitable packaging units of the thermometer sheaths
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
on Medical Thermometry. or probe covers shall bear in legible characters a designation
Current edition approved May 10, 2003. Published July 2003. Originally
(either a serial number or a code) to indicate the specific
approved in 1986. Last previous edition approved in 1998 as E1104–1998.
manufacturing lot in addition to all other applicable labeling.
Annual Book of ASTM Standards, Vol 14.03.
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E 1104 – 98 (2003)
Suitable packaging units and other labeling shall also bear a conformance of probe covers or sheaths to the requirements of
statement that the thermometer probe covers or sheaths are this specification. Each producer or distributor representing
intended for single use only. products as conforming to this specification may use statisti-
4.6.3 The temperature-taking device for which the clinical cally based sampling plans that are appropriate for each
thermometerprobecoverorsheathisorisn
...