ISO 80601-2-56:2017/Amd 1:2018

Overview

ISO 80601-2-56:2017/Amd 1:2018 is an international standard issued by ISO that specifies particular requirements for the basic safety and essential performance of clinical thermometers used for body temperature measurement. This amendment updates the second edition of the standard, published in 2017, enhancing clarity, usability, and safety measures to reflect current medical device technology and regulatory expectations.

The standard applies to medical electrical equipment (Me equipment) that measures and displays a patient’s body temperature, including devices using temperature probes integrated with other accessories such as pulmonary artery catheters or Foley catheters.

Key Topics

• Safety and Performance Requirements
  Ensures clinical thermometers meet stringent safety criteria to avoid risks to patients and healthcare providers. Devices must provide accurate, reliable temperature readings within specified ranges, particularly from 34.0 °C to 42.0 °C, critical for clinical decision-making.
• Technical Alarm Conditions
  Clinical thermometers must incorporate alarms or withhold temperature output when measurements fall outside preset accuracy limits or operational parameters, e.g., due to low power or sensor failure.
• Terminology and Usage Clarifications
  The amendment refines the interpretation of key terms such as "may," "can," and "must" to distinguish between permissions, capabilities, and mandatory constraints related to device compliance and usage.
• Scope Clarifications
  Expands the definition of Me equipment in scope to explicitly include thermometry-related accessories that display body temperature, ensuring comprehensive coverage.
• Documentation and Usability Improvements
  Updates formatting and titles in annexes and tables for improved readability and usability by manufacturers, regulatory personnel, and clinicians.

Applications

This standard is essential for manufacturers and developers of clinical thermometers and related medical devices to:

• Achieve regulatory compliance with international safety and performance standards for body temperature measurement devices.
• Design thermometers that integrate smoothly with accessories in advanced clinical environments, including catheters used in cardiac monitoring.
• Implement safety features such as alarms for device malfunction or readings outside of laboratory accuracy thresholds to enhance patient safety.
• Ensure devices meet reliability criteria for use in a wide range of clinical settings including hospitals, outpatient clinics, and home care environments.
• Provide clinicians accurate, trustworthy measurements to support diagnosis, treatment, and patient monitoring.

Related Standards

ISO 80601-2-56:2017/Amd 1:2018 is part of the broader ISO/IEC 80601 series, which covers general safety and performance requirements for medical electrical equipment. Key related standards include:

• ISO 80601-2-61 - Particular requirements for basic safety and essential performance of pulse oximeter equipment.
• ISO 80601-2-12 - Requirements for critical care ventilators, offering guidance on respiratory device safety.
• ISO 14971 - Risk management for medical devices, applicable across all device development including clinical thermometers.
• IEC 60601-1 - General requirements for basic safety and essential performance of medical electrical equipment.

By aligning with ISO 80601-2-56 and its amendments, manufacturers ensure their clinical thermometers not only meet global safety benchmarks but also achieve high usability and functional reliability essential for critical healthcare applications.

Keywords: clinical thermometer standard, body temperature measurement, medical electrical equipment safety, clinical thermometer performance, ISO 80601-2-56 amendment, medical device compliance, temperature measurement accuracy, patient monitoring equipment.