ASTM E1104-98(2023)

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.  
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

General Information

• Status: Published
• Publication Date: 31-Jan-2023
• 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

• Refers: ASTM E344-23 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-Dec-2023
• Refers: ASTM E344-19 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-Sep-2019
• Refers: ASTM E1112-00(2018) - Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
• Effective Date: 01-Oct-2018
• Refers: ASTM E344-18 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-Apr-2018
• Refers: ASTM E344-16 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-Nov-2016
• Refers: ASTM E344-13 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-May-2013
• Refers: ASTM E344-12 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-May-2012
• Refers: ASTM E1112-00(2011) - Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
• Effective Date: 01-Jun-2011
• Refers: ASTM E344-10 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-Nov-2010
• Refers: ASTM E667-98(2009) - Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
• Effective Date: 15-Oct-2009
• Refers: ASTM E344-08 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 15-Nov-2008
• Refers: ASTM E344-07 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-Jun-2007
• Refers: ASTM E344-06 - Terminology Relating to Thermometry and Hydrometry
• Effective Date: 01-May-2006
• Refers: ASTM E1112-00(2006) - Standard Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature
• Effective Date: 01-May-2006
• Refers: ASTM E667-98(2003) - Standard Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers
• Effective Date: 10-May-2003

Overview

ASTM E1104-98(2023): Standard Specification for Clinical Thermometer Probe Covers and Sheaths sets forth internationally recognized requirements for single-use probe covers and sheaths intended for use with any clinical thermometer. Developed by ASTM International, this specification ensures probe covers and sheaths provide adequate protection for both patients and healthcare personnel, facilitating safe and reliable temperature measurement procedures. The standard details safety, toxicity, integrity, compatibility, labeling, and testing criteria, supporting confidence in clinical thermometry practices.

Key Topics

• Scope: Applies to all single-use clinical thermometer probe covers and sheaths, regardless of thermometer type.
• Patient Protection: Requirements guarantee sufficient isolation between patient and thermometer, protecting health and safety.
• Physical Integrity: Covers and sheaths must maintain structural strength during application, use, and removal.
• Toxicity: Only non-toxic materials may contact patients, supporting biocompatibility standards.
• Labeling and Packaging: Clear labeling on packaging is required, including single-use designation, lot identification, and applicable compatibility statements.
• Device Compatibility: Probe covers and sheaths must not degrade thermometer accuracy or function.
• Testing Procedures: Includes defined tests for toxicity, leakage, and compatibility to verify conformance to safety and performance requirements.

Applications

ASTM E1104-98(2023) is highly relevant for manufacturers, healthcare facilities, and distributors involved in the production, selection, and quality assurance of clinical thermometer probe covers and sheaths. Practical applications include:

• Product Development: Manufacturers must design probe covers and sheaths to comply with safety, labeling, and performance requirements outlined in this standard.
• Regulatory Compliance: Demonstrating conformity to ASTM E1104 helps meet health authority and procurement criteria in hospitals, clinics, and laboratories.
• Quality Assurance: Regular testing for toxicity, leakage, and physical integrity ensures consistent batch-to-batch reliability.
• User Guidance and Training: Clear instructions, as stipulated in the standard, support safe handling and correct usage by healthcare professionals, reducing cross-contamination risks.
• Market Access: Compliance with an internationally recognized standard facilitates access to global markets and streamlines purchasing decisions.

Related Standards

Several important ASTM standards are referenced in ASTM E1104-98(2023), offering complementary guidance for temperature measurement devices and associated materials:

• ASTM E344: Terminology Relating to Thermometry and Hydrometry
• ASTM E667: Specification for Mercury-in-Glass, Maximum Self-Registering Clinical Thermometers (Withdrawn 2022)
• ASTM E1112: Specification for Electronic Thermometer for Intermittent Determination of Patient Temperature

Meeting the requirements of ASTM E1104-98(2023) helps ensure clinical thermometer probe covers and sheaths contribute to accurate and safe temperature measurement. For technical and procurement teams seeking reliable, high-quality medical disposables, adhering to this standard is essential for healthcare safety and compliance.

Keywords: clinical thermometer, probe covers, sheaths, single-use, ASTM E1104, safety, toxicity, compatibility, healthcare, temperature measurement, medical devices, leakage test, labeling requirements

Standards Content (Sample)

This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E1104 − 98 (Reapproved 2023)
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. 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. Terminology
3.1 Definitions—The definitions given in Terminology E344
1.1 This specification covers all single-use clinical ther-
shall apply to this specification with the following additions:
mometer probe covers and sheaths intended for use with any
clinical thermometer. Requirements are given for safety,
3.2 Definitions of Terms Specific to This Standard:
toxicity, handling, labeling, and physical integrity. Testing
3.2.1 measurement time, n—time required from time of
procedures for appropriate requirements and a glossary of
patient contact to the time when the clinical thermometer may
terms used within the standards are provided. be removed or read to within its stated accuracy of the clinical
thermometer.
1.2 The requirements contained herein are intended to
3.2.2 patient, n—any human whose temperature is being
ensure adequate isolation of the patient from the temperature-
taken.
measuring device. In addition, the safety and health of the
patient shall not be adversely affected. When used in accor- 3.2.3 probe, n—an assembly including the transducer that is
used to position the transducer in the specific location from
dance with the manufacturer’s instructions, the probe cover,
sheath, and temperature-measuring device shall remit correct which the temperature is to be determined.
temperature readings as required in Specifications E667 and
3.2.4 probe covers and sheaths, n—devices provided for the
E1112.
purpose of preventing biological contact between the patient
and the probe or clinical thermometer.
1.3 This international standard was developed in accor-
3.2.5 suitable packaging unit, n—the unit(s) of packaging
dance with internationally recognized principles on standard-
for which a specific requirement of marking and labeling is
ization established in the Decision on Principles for the
logically applicable. It shall not be less than the smallest unit
Development of International Standards, Guides and Recom-
intended for sale by the manufacturer or distributor to the final
mendations issued by the World Trade Organization Technical
user.
Barriers to Trade (TBT) Committee.
4. Requirements
2. Referenced Documents
4.1 General—Clinical thermometer probe covers and
2.1 ASTM Standards:
sheaths represented as complying with this specification shall
E344 Terminology Relating to Thermometry and Hydrom-
meet all of the requirements specified herein.
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 (Withdrawn 2022)
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.
4.3 Physical Integrity—The clinical thermometer probe
This specification is under the jurisdiction of ASTM Committee F04 on
covers and sheaths shall be constructed and packaged so that
Medical and Surgical Materials and Devices and is the direct responsibility of
the physical integrity of the probe covers and sheaths will be
Subcommittee F04.33 on Medical/Surgical Instruments.
Current edition approved Feb. 1, 2023. Published February 2023. Originally maintained when applied to, used, and removed from a
approved in 1986. Last previous edition approved in 2016 as E1104 – 98 (2016).
temperature-taking device as prescribed by the manufacturer
DOI: 10.1520/E1104-98R23.
(see 5.3).
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
4.4 Toxicity—When the probe covers or sheaths are used as
Standards volume information, refer to the standard’s Document Summary page on
specified by the manufacturers, its parts intended for contact
the ASTM website.
with anatomical sites during patient use shall be nontoxic (see
The last approved version of this historical standard is referenced on www.ast-
m.org. 5.1).
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1104 − 98 (2023)
4.5 Compatibility—The clinical thermometer probe covers 5. Testing Procedures
and sheaths shall be compatible with the intended use of the
5.1 Significance and Use—This section describes the proce-
temperature-taking device (see 5.4.1).
dures necessary to verify conformance to certain requirements
of Section 4. Procedures that can be verified by observation are
4.6 Labeling:
not included. The inspection and test procedures contained in
4.6.1 Instructions shall be provided for proper usage of
this specification are used to determine the conformance of
clinical thermometer probe covers or sheaths.
probe covers or sheaths to the requirements of this specifica-
4.6.2 Suitable packaging units of the thermometer sheaths
tion. Each
...