EN ISO 12487:2026

Overview

EN ISO 12487:2026 - Medical electrical equipment - Clinical performance evaluation of clinical thermometers (ISO 12487:2026) is an international standard developed by CEN that sets forth requirements and methodologies for the clinical performance evaluation of medical electrical (ME) equipment used to measure body temperature in indirect measurement mode. The standard is essential for manufacturers and regulatory bodies to ensure that clinical thermometers, both intermittently and continuously measuring, provide accurate and reliable body temperature measurements when applied to patients.

This document specifically covers predictive-type thermometers with claimed measurement times of less than 60 seconds for oral or rectal methods, and less than 5 minutes for axillary measurements. Direct measurement mode thermometers and screening thermographs for febrile temperature assessment are excluded from its scope, as are devices such as pulmonary artery catheters for cardiac output determination.

Key Topics

• Scope and Applicability
  EN ISO 12487:2026 applies to clinical thermometers that measure the body temperature indirectly, focusing on both predictive and continuous measurement devices for medical use. The standard outlines when clinical investigations are mandatory and distinguishes requirements for thermometers with different measurement modes and timeframes.

• Clinical Investigation Requirements
  The standard specifies minimum subject numbers (at least 75 per mode) and age distribution guidelines for clinical studies. It provides clear criteria for body temperature range representation, including the need for subjects across various temperature thresholds and age groups.

• Investigation Methods
  Clinical investigation approaches must ensure proper environmental control, subject preparation, and the use of accurate reference site thermometers. The standard includes requirements for environmental monitoring, subject stabilization procedures, and reference thermometer selection to eliminate biases in performance evaluation.

• Good Clinical Practice
  All clinical tests must comply with recognized good clinical practice (GCP) as defined by ISO 14155. This includes ethical considerations, subject safety, and accurate reporting of results.

• Disclosure and Documentation
  EN ISO 12487:2026 mandates additional disclosure in product accompanying information, confirming successful completion of a clinical investigation in compliance with the standard.

Applications

EN ISO 12487:2026 is valuable for:

• Manufacturers of medical thermometers
  Assisting device manufacturers in designing, validating, and documenting the clinical performance of thermometers intended for professional healthcare settings, ensuring their products meet international requirements before market entry.

• Healthcare Institutions and Clinical Investigators
  Providing clear criteria for conducting clinical trials on thermometers, supporting institutions in verifying equipment reliability and safety prior to adoption in clinical protocols.

• Regulatory Assessments
  Offering regulatory agencies a standardized basis for evaluating thermometer performance claims and supporting conformity assessments for CE marking or other market approvals.

• Quality Assurance Professionals
  Enabling quality and compliance teams to establish robust investigation and recordkeeping processes for temperature measurement devices.

Related Standards

For comprehensive compliance and best practice, consider the following complementary standards:

• ISO 80601-2-56: Medical electrical equipment – Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (applicable for direct mode devices).
• ISO 14155: Clinical investigation of medical devices for human subjects – Good clinical practice (GCP).
• IEC 60601-1: Medical electrical equipment – General requirements for basic safety and essential performance.
• IEC 80601-2-59: Particular requirements for laboratory accuracy in screening thermographs for human febrile temperature screening.

By harmonizing with EN ISO 12487:2026, stakeholders ensure that medical thermometers used in clinical environments provide consistent, accurate, and reliable body temperature measurements, supporting improved patient outcomes and regulatory compliance.