ASTM E1299-96(2023) PDF

Overview

ASTM E1299-96(2023), Standard Specification for Reusable Phase-Change-Type Fever Thermometer for Intermittent Determination of Human Temperature, defines the requirements for reusable clinical thermometers that utilize phase-change materials to accurately measure and indicate human body temperature. Published by ASTM International, this standard ensures consistent performance and safety for devices intended for medical and clinical settings.

Designed to promote product reliability and user safety, ASTM E1299-96(2023) establishes criteria for performance, marking, cleanliness, toxicity, and environmental durability. Adherence to this specification supports international trade, enhances user confidence, and aligns with globally recognized standardization principles.

Key Topics

• Phase-Change-Type Thermometer Definition A reusable clinical thermometer that uses phase-change materials to detect and indicate an anatomical site temperature by visibly changing state.

• Measurement Range and Accuracy

  • Temperature range: 35.5 to 40.4 °C (96.0 to 104.8 °F)
  • Maximum error allowed: varies from ±0.1 °C/°F to ±0.4 °C/°F, depending on the specific temperature range

• Retention Time Accurate readings must be retained for a minimum of 20 seconds after measurement.

• Scale Graduations

  • Celsius: intervals not greater than 0.1 °C, with numerals at every 0.5 °C
  • Fahrenheit: intervals not greater than 0.2 °F, with numerals at every 1 °F

• Durability Requirements Thermometers must maintain performance after prolonged exposure to extreme temperatures and varying humidity, as well as over a three-year minimum shelf life.

• Safety and Toxicity Thermometers must be nontoxic in all parts intended for direct contact, assessed via tests for acute oral toxicity, skin, and eye irritation.

• Instructions and Marking Products must be delivered with clear operating, care, and cleaning instructions, suitable labeling, and unique lot identification.

Applications

Organizations use ASTM E1299-96(2023) to ensure the quality and safety of reusable phase-change fever thermometers for intermittent human temperature measurement, making it highly relevant for:

• Healthcare Providers and Hospitals Standardized fever thermometers help clinicians obtain reliable body temperature readings for diagnostic and monitoring purposes.

• Manufacturers and Distributors Compliance streamlines product development, batch testing, and global market access, facilitating adherence to FDA or equivalent regulations.

• Regulatory Bodies Reference to this standard supports medical device approvals, procurement, and compliance assessments, especially for import/export control.

• Clinical Laboratories Ensures reliable measurements in routine health checks, screenings, and clinical studies involving human temperature monitoring.

• Product Testing Facilities Guides testing protocols for calibration, accuracy verification, and environmental stress testing of phase-change thermometers.

Related Standards

For comprehensive quality assurance and regulatory compliance, consider these additional standards related to thermometry and medical device safety:

• ASTM E344 - Terminology Relating to Thermometry and Hydrometry Provides terminology and definitions essential for understanding thermometric devices and measurements.

• ASTM F895 - Test Method for Agar Diffusion Cell Culture Screening for Cytotoxicity Used to assess the cytotoxic potential of device materials, important for patient safety.

• CFR Title 21, Section 191 Part of the U.S. Code of Federal Regulations for medical devices, referencing toxicity and irritation tests.

ASTM E1299-96(2023) offers significant practical value by promoting consistent standards for reusable fever thermometers in healthcare and clinical environments. Following this specification helps protect patient safety, ensures accuracy in temperature measurement, and facilitates international acceptance of medical thermometry devices.