ISO 80601-2-56-2017 amd1-2018 PDF

Full title and description

ISO 80601-2-56:2017/Amd 1:2018 — Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement — Amendment 1. This document is a short amendment that modifies and supplements ISO 80601-2-56:2017 and is intended to be applied together with that edition of the standard.

Abstract

This amendment (Amd 1:2018) provides changes and/or corrections to ISO 80601-2-56:2017, which specifies particular requirements for the basic safety and essential performance of electrical clinical thermometers used for body temperature measurement. The amendment itself is concise (two pages) and is issued to update or correct specific technical or editorial items in the 2017 edition.

General information

• Status: Published.
• Publication date: 4 December 2018 (Amendment published in December 2018; sometimes shown as Nov/Dec 2018 in catalogues).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.040.55 (Diagnostic equipment).
• Edition / version: Edition 2 — Amendment 1 (2018).
• Number of pages: 2 (amendment document length).

Scope

The amendment applies to ISO 80601-2-56:2017 and updates the particular requirements that govern basic safety and essential performance of clinical thermometers intended for measuring human body temperature. The parent standard covers electrical clinical thermometers (in combination with accessories) and specifically excludes screening thermographs for group febrile screening (see IEC 80601-2-59). The amendment should be read together with the full 2017 text to determine exactly which clauses are changed or corrected.

Key topics and requirements

• Corrections or additions to wording, test conditions or performance criteria in ISO 80601-2-56:2017 that affect how clinical thermometers are tested and evaluated.
• References and cross-references to general electrical medical equipment safety requirements (for example IEC/ISO requirements used by the parent standard).
• Clarifications on the intended scope (clinical thermometers for patient body-temperature measurement) and explicit exclusion of screening thermographs for group screening.
• Editorial or minor technical corrections intended to be applied directly to the 2017 edition (amendment format: short, specific changes rather than full-rewrite).

Typical use and users

Manufacturers of clinical thermometers and their accessories, conformity assessment and test laboratories, regulatory authorities assessing medical electrical equipment, hospital/clinic procurement and biomedical engineering teams, and standards committees referencing clinical thermometer requirements typically use this amendment together with ISO 80601-2-56:2017 when demonstrating conformity to safety and performance requirements.

Related standards

Key related documents include the parent ISO 80601-2-56:2017 (Part 2-56), general medical electrical equipment safety standards (IEC 60601-1 family), and IEC 80601-2-59 (requirements for screening thermographs). Quality management and risk-management standards commonly used alongside this standard include ISO 13485 and ISO 14971.

Keywords

clinical thermometer; body temperature measurement; medical electrical equipment; amendment; ISO 80601-2-56; IEC 60601; performance requirements; essential performance; safety.

FAQ

Q: What is this standard?

A: ISO 80601-2-56:2017/Amd 1:2018 is Amendment 1 (2018) to ISO 80601-2-56:2017, which contains particular requirements for the basic safety and essential performance of electrical clinical thermometers for measuring human body temperature.

Q: What does it cover?

A: It provides specific corrections or additions to the 2017 Part 2-56 standard; the parent standard defines the technical and testing requirements for electrical clinical thermometers and their accessories, and explicitly excludes screening thermographs used for group febrile screening.

Q: Who typically uses it?

A: Equipment manufacturers, test houses, regulatory bodies, hospital biomedical engineering departments, and standards/technical committees who need to apply or verify the updated requirements for clinical thermometers.

Q: Is it current or superseded?

A: The amendment (published Dec 2018) is a published update to the 2017 edition; users should check the current status of ISO 80601-2-56 (and any further amendments or new editions) before relying on it for conformity assessments. (The parent standard and amendment have been in the ISO catalogue with stability dates and later revision activity noted.)

Q: Is it part of a series?

A: Yes. ISO 80601-2-56 is a Part 2-x family document in the IEC/ISO medical electrical equipment series (the 80601 series) that contains particular requirements for different types of medical electrical equipment; it is used together with general requirements (IEC 60601-1) and other relevant Part 2-x standards.

Q: What are the key keywords?

A: Clinical thermometer, body temperature, medical electrical equipment, essential performance, safety, amendment, ISO 80601-2-56.