ASTM E1104-98(2016)
(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 manufacturer’s instructions, the probe cover, sheath, and temperature measuring device shall remit correct temperature readings as required in Specifications E667 and E1112.
General Information
Buy Standard
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: E1104 − 98 (Reapproved 2016)
Standard Specification for
1
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. A number 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—devices provided for the
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 manufacturer’s 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
2
sheaths represented as complying with this specification shall
2.1 ASTM Standards:
meet all of the requirements specified herein.
E344 Terminology Relating to Thermometry and Hydrom-
etry
4.2 Product Safety—Sheaths and probe covers shall be
E667 Specification for Mercury-in-Glass, Maximum Self-
constructed to preclude sharp points and edges that could cause
Registering Clinical Thermometers
patient injury. Probe covers and sheaths shall be constructed in
E1112 Specification for Electronic Thermometer for Inter-
such a way that the person using them can install and remove
mittent Determination of Patient Temperature
them without touching that portion of the probe cover or sheath
that comes in contact with the patient.
3. Terminology
4.3 Physical Integrity—The clinical thermometer probe
3.1 Definitions—The definitions given in Terminology E344
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).
be removed or read to within its stated accuracy of the clinical
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
1
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 Oct. 1, 2016. Published October 2016. Originally and sheaths shall be compatible with the intended use of the
approved in 1986. Last previous edition approved in 2009 as E1104 – 1998 (2009).
temperature-taking device (see 5.4.1).
DOI: 10.1520/E1104-98R16.
2
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1104 − 98 (2016)
4.6.2 Suitable packaging units of the thermometer sheaths not included. The inspection and test procedures contained in
or probe covers shall bear
...
This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: E1104 − 98 (Reapproved 2009) E1104 − 98 (Reapproved 2016)
Standard Specification for
1
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. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. 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
manufacturersmanufacturer’s instructions, the probe cover, sheath, and temperature measuring device shall remit correct
temperature readings as required in Specifications E667 and E1112.
2. Referenced Documents
2
2.1 ASTM Standards:
E344 Terminology Relating to Thermometry and Hydrometry
E667 Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
E1112 Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
3. Terminology
3.1 Definitions—The definitions given in Terminology E344 shall apply to this Specification with the following additions:
3.2 Definitions of Terms Specific to This Standard:
3.2.1 measurement time, n—time required from time of patient contact to the time when the clinical thermometer may be
removed or read to within theits stated accuracy of the clinical thermometer.
3.2.2 patient, n—any human whose temperature is being taken.
3.2.3 probe, n—an assembly including the transducer that is used to position the transducer in the specific location from which
the temperature is to be determined.
3.2.4 probe covers and sheaths, n—devices provided for the purpose of preventing biological contact between the patient and
the probe or clinical thermometer.
3.2.5 suitable packaging unit, n—the unit(s) of packaging for which a specific requirement of marking and labeling is logically
applicable. It shall not be less than the smallest unit intended for sale by the manufacturer or distributor to the final user.
4. Requirements
4.1 General—Clinical thermometer probe covers and sheaths represented as complying with this specification shall meet all of
the requirements specified herein.
4.2 Product Safety—Sheaths and probe covers shall be constructed to preclude sharp points and edges that could cause patient
injury. Probe covers and sheaths shall be constructed in such a way that the person using them can install and remove them without
touching that portion of the probe cover or sheath that comes in contact with the patient.
1
This specification is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.33 on Medical/Surgical Instruments.
Current edition approved May 1, 2009Oct. 1, 2016. Published June 2009October 2016. Originally approved in 1986. Last previous edition approved in 20032009 as
E1104 – 1998 (2003).(2009). DOI: 10.1520/E1104-98R09.10.1520/E1104-98R16.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM Standards
volume information, refer to the standard’sstandard’s Document Summary page on the ASTM website.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
E1104 − 98 (2016)
4.3 Physical Integrity—The clinical thermometer probe covers and sheaths shall be constructed and packaged so that the
physical integrity of the probe covers and sheaths will be maintained when applied to, used, and removed from a
temperature-taking device as prescribed by the manufacturer (see 5.3).
4.4 Toxicity—When the probe covers or sheaths are used as specified by the manufacturers, its parts intended for contact with
anatomical sites during patient use shall be nontoxic (see 5.1).
4.5 Compatibility—The clinical thermometer probe covers and she
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.