Overview
SIST EN ISO 12487:2026 defines internationally recognized requirements and procedures for conducting the clinical performance evaluation of medical electrical (ME) equipment, specifically clinical thermometers, utilized for indirect body temperature measurement. The standard encompasses thermometers measuring intermittently or continuously, such as those used for oral, rectal, axillary (armpit), tympanic (ear), and forehead sites-provided their claimed measurement time is under 60 seconds (oral/rectal) or 5 minutes (axillary).
This standard ensures that clinical thermometers in indirect measurement mode are accurately and safely evaluated for clinical performance prior to market introduction or clinical use. Its methods form a critical element of regulatory and quality compliance for manufacturers and healthcare providers.
Key Topics
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Scope and Applicability
- Applies to both intermittent and continuous clinical thermometers for indirect measurement mode
- Excludes thermometers using direct measurement mode (see ISO 80601-2-56 for those devices)
- Not intended for screening thermographs (IEC 80601-2-59) or pulmonary artery catheterization devices
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Clinical Investigation Requirements
- At least 75 subjects for each thermometer mode, with age and temperature distribution addressed
- Age distribution: subjects must cover all intended age groups; at least 25 per group
- Temperature distribution: at least 30% below and 30% above 37.5°C
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Methodology
- Clear criteria for preparing subjects, including environmental and physiological stabilization
- Reference site thermometer requirements: laboratory accuracy, usage protocol, and site alignment with the intended measurement site
- Clinical thermometer tested with appropriate probe covers and in all intended modes
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Performance Metrics and Analysis
- Detailed calculation and evaluation of clinical bias, repeatability, and standard deviation
- Conformity assessed through clinical investigation reports and documentation
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Disclosure and Compliance
- Manufacturers must clearly state successful clinical investigation as per the standard in accompanying information
Applications
SIST EN ISO 12487:2026 provides essential guidance and assurance for:
- Medical Device Manufacturers: Structuring clinical performance evaluation, essential for CE marking, regulatory submissions, and market approval for new or modified clinical thermometers.
- Clinical Investigators and Laboratories: Implementing robust, standardized protocols for the clinical testing of indirect reading thermometers, ensuring data validity and comparability.
- Hospitals and Healthcare Facilities: Assuring procurement teams and clinicians that devices meet recognized safety and performance standards for patient temperature assessment.
- Regulatory Authorities: Evaluating evidence of clinical performance for device approval and post-market surveillance.
By strictly adhering to criteria set forth in this standard, stakeholders contribute to patient safety, regulatory compliance, and product quality across healthcare environments where body temperature measurement is a core clinical indicator.
Related Standards
Consider the following standards for complete guidance and cross-reference:
- ISO 80601-2-56: Medical electrical equipment-Requirements for clinical thermometers in direct measurement mode
- IEC 80601-2-59: Medical electrical equipment-Requirements for screening thermographs for human febrile temperature screening
- ISO 14155: Clinical investigation of medical devices for human subjects-Good clinical practice
- IEC 60601-1: General requirements for basic safety and essential performance of medical electrical equipment
SIST EN ISO 12487:2026 supports harmonization with international requirements, ensuring consistent, reliable evaluation of clinical thermometers used in routine and critical patient care.