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ASTM E1104-98

(Specification)

Standard Specification for Clinical Thermometers Probe Covers and Sheaths

Standard Specification for Clinical Thermometers Probe Covers and Sheaths

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 E667 and E1112.

General Information

Status
Historical
Publication Date
09-Apr-1998
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.33 - Medical/Surgical Instruments
Current Stage
Ref Project

Relations

Replaced By
ASTM E1104-98(2003) - Standard Specification for Clinical Thermometer Probe Covers and Sheaths
Effective Date
10-May-2003

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ASTM E1104-98 - Standard Specification for Clinical Thermometers Probe Covers and SheathsASTM E1104-98 - Standard Specification for Clinical Thermometers Probe Covers and Sheaths
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ASTM E1104-98 - Standard Specification for Clinical Thermometers Probe Covers and Sheaths
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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
AMERICAN SOCIETY FOR TESTING AND MATERIALS
100 Barr Harbor Dr., West Conshohocken, PA 19428
Reprinted from the Annual Book of ASTM Standards. Copyright ASTM
Standard Specification for
1
Clinical Thermometer Probe Covers and Sheaths
This standard is issued under the fixed designation E 1104; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope 3.2.4 probe, n—an assembly including the transducer that is
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
3.2.5 suitable packaging unit, n—the unit(s) of packaging
clinical thermometer. Requirements are given for safety, tox-
for which a specific requirement of marking and labeling is
icity, handling, labeling, and physical integrity. Testing proce-
logically applicable. It shall not be less than the smallest unit
dures for appropriate requirements and a glossary of terms used
intended for sale by the manufacturer or distributor to the final
within the standards are provided.
user.
1.2 The requirements contained herein are intended to
ensure adequate isolation of the patient from the temperature-
4. Requirements
measuring device. In addition, the safety and health of the
4.1 General—Clinical thermometer probe covers and
patient shall not be adversely affected. When used in accor-
sheaths represented as complying with this specification shall
dance with the manufacturers instructions, the probe cover,
meet all of the requirements specified herein.
sheath, and temperature measuring device shall remit correct
4.2 Product Safety—Sheaths and probe covers shall be
temperature readings as required in Specifications E 667 and
constructed to preclude sharp points and edges that could cause
E 1112.
patient injury. Probe covers and sheaths shall be constructed in
2. Referenced Documents such a way that the person using them can install and remove
them without touching that portion of the probe cover or sheath
2.1 ASTM Standards:
that comes in contact with the patient.
E 344 Terminology Relating to Thermometry and Hydrom-
2
4.3 Physical Integrity—The clinical thermometer probe
etry
covers and sheaths shall be constructed and packaged so that
E 667 Specification for Clinical Thermometers (Maximum
2
the physical integrity of the probe covers and sheaths will be
Self-Registering, Mercury-in-Glass)
maintained when applied to, used, and removed from a
E 1112 Specification for Electronic Thermometers for Inter-
2
temperature-taking device as prescribed by the manufacturer
mittent Determination of Patient Temperature
(see 5.3).
3. Terminology
4.4 Toxicity—When the probe covers or sheaths are used as
specified by the manufacturers, its parts intended for contact
3.1 Definitions—The definitions given in Terminology
with anatomical sites during patient use shall be nontoxic (see
E 344 shall apply to this Specification with the following
5.1).
additions:
4.5 Compatibility—The clinical thermometer probe covers
3.2 Definitions of Terms Specific to This Standard:
and sheaths shall be compatible with the intended use of the
3.2.1 probe covers and sheaths, n—devices provided for the
temperature-taking device (see 5.4.1).
purpose of preventing biological contact between the patient
4.6 Labeling:
and the probe or clinical thermometer.
4.6.1 Instructions shall be provided for proper usage of
3.2.2 measurement time, n—time required from time of
clinical thermometer probe covers or sheaths.
patient contact to the time when the clinical thermometer may
4.6.2 Suitable packaging units of the thermometer sheaths
be removed or read to within the stated accuracy of the clinical
or probe covers shall bear in legible characters a designation
thermometer.
(either a serial number or a code) to indicate the specific
3.2.3 patient, n—any human whose temperature is being
manufacturing lot in addition to all other applicable labeling.
taken.
Suitable packaging units and other labeling shall also bear a
statement that the thermometer probe covers or sheaths are
1
This specification is under the jurisdiction of ASTM Committee E-20 on
intended for single use only.
Temperature Measurement and is the direct responsibility of Subcommittee E20.08
on Medical Thermometry. 4.6.3 The temperature-taking device for which the clinical
Current edition approved April 10, 1998. Published March 1999. Originally
thermometer probe cover or sheath is or is not intended shall be
published as E 1104 – 86. Last previous edition E 1104 – 86 (1
...

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