ISO 80601-2-56-2017 PDF

Full title and description

ISO 80601-2-56:2017 — Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. This International Standard specifies general and technical requirements for electrical clinical thermometers (ME equipment) used to measure patient body temperature; it addresses thermometer equipment in combination with accessories and defines requirements for safety, essential performance and interfacing with auxiliary devices.

Abstract

This standard applies to the basic safety and essential performance of clinical thermometers and associated accessories when used for measuring human body temperature. It specifies performance, testing and documentation requirements for electrical clinical thermometers, and clarifies that auxiliary equipment used only for non-primary temperature measurement is outside its scope. The document also notes exclusions for febrile screening thermographs, which are covered by other standards.

General information

• Status: Published (active standard, Edition 2).
• Publication date: March 2017 (Edition 2 published in 2017; amendment published in December 2018).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.55 (Medical equipment).
• Edition / version: Edition 2 (ISO 80601-2-56:2017) with Amendment 1 published 2018.
• Number of pages: 49 pages (main document); Amendment 1 is 2 pages.

Scope

ISO 80601-2-56:2017 covers electrical clinical thermometers intended for measuring patient body temperature, including requirements for basic safety, essential performance, test methods, environmental and mechanical conditions, interfaces to secondary indicators and accessories when used as ME systems. It excludes auxiliary equipment that does not form part of the ME equipment and excludes thermograph screening devices used for mass febrile screening, which are covered by dedicated standards.

Key topics and requirements

• Requirements for basic safety and essential performance of clinical (electrical) thermometers.
• Accuracy, measurement uncertainty and performance testing methods for body-temperature measurement.
• Environmental, mechanical and electrical test conditions (including interfacing with secondary indicators and accessories).
• Risk management and conformity with general medical electrical equipment safety principles (referencing IEC 60601-1 requirements where applicable).
• Labeling, instructions for use and clinical performance documentation requirements.
• Requirements and limitations for use (what is in-scope versus excluded devices such as thermographs for mass screening).

These topics are developed as particular requirements within the ISO 80601 series for medical electrical equipment; the standard references IEC/ISO general safety requirements where relevant.

Typical use and users

Primary users include medical device manufacturers (design, verification and validation teams), regulatory and compliance professionals, clinical engineers, testing laboratories and conformity assessment bodies. The standard is used during design and type-testing of clinical thermometers, for technical documentation supporting regulatory submissions, and by procurement/specification teams in healthcare organizations.

Related standards

Key related publications and families include the general medical electrical equipment safety standard IEC 60601-1 (and its amendments), other particular‑part standards in the ISO/IEC 80601 series, and standards for febrile screening thermographs (for example IEC 80601-2-59). Historical and regional adoptions (e.g., EN ISO variants) and ISO 80601-2-56:2017/Amd 1:2018 (Amendment 1) are directly associated.

Keywords

clinical thermometer, body temperature, thermometry, medical electrical equipment, ME equipment, basic safety, essential performance, accuracy, calibration, IEC 60601, thermograph (exclusion), ISO 80601 series.

FAQ

Q: What is this standard?

A: ISO 80601-2-56:2017 is an ISO particular‑part standard that defines basic safety and essential performance requirements for electrical clinical thermometers used to measure human body temperature.

Q: What does it cover?

A: It covers design, performance, testing, labeling and documentation requirements for clinical thermometers (ME equipment) and their interfaces with accessories and secondary indicators; it excludes auxiliary devices not forming part of the ME equipment and mass febrile‑screening thermographs covered by other standards.

Q: Who typically uses it?

A: Device manufacturers, test laboratories, regulatory and quality professionals, clinical engineers and procurement/specification teams in healthcare.

Q: Is it current or superseded?

A: The Edition 2 text (ISO 80601-2-56:2017) is published and active; an Amendment (ISO 80601-2-56:2017/Amd 1:2018) was published in 2018. The standard is subject to periodic review and has been listed for revision activity. Check your national body or the ISO catalogue for the very latest status before relying on it for certification decisions.

Q: Is it part of a series?

A: Yes — it is a "particular requirements" document within the ISO/IEC 80601 family for medical electrical equipment (which works alongside the general IEC 60601 series).

Q: What are the key keywords?

A: Clinical thermometer, body temperature, thermometry, medical electrical equipment, essential performance, basic safety, accuracy, calibration, IEC 60601.