GSO ISO 80601-2-56:2021

ISO 80601-2-56:2017
Gulf Standard   Current Edition · Approved on 01 July 2021

Medical electrical equipment — Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement

GSO ISO 80601-2-56:2021 Files

GSO ISO 80601-2-56:2021 Scope

ISO 80601-2-56:2017 applies to the basic safety and essential performance of a clinical thermometer in combination with its accessories, hereafter referred to as me equipment. This document specifies the general and technical requirements for electrical clinical thermometers. This document applies to all electrical clinical thermometers that are used for measuring the body temperature of patients.

Clinical thermometers can be equipped with interfaces to accommodate secondary indicators, printing equipment, and other auxiliary equipment to create me systems. This document does not apply to auxiliary equipment.

Me equipment that measures a body temperature is inside the scope of this document.

ISO 80601-2-56:2017 does not specify the requirements for screening thermographs intended to be used for the individual non-invasive human febrile temperature screening of groups of individual humans under indoor environmental conditions, which are given in IEC 80601‑2‑59[4].

If a clause or subclause is specifically intended to be applicable to me equipment only, or to me systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to me equipment and to me systems, as relevant.

Hazards inherent in the intended physiological function of me equipment or me systems within the scope of this document are not covered by specific requirements in this document except in IEC 60601‑1:2005+A1:2012, 7.2.13 and 8.4.1.

NOTE Additional information can be found in IEC 60601?1:2005+A1:2012, 4.2.

Best Sellers From Health Sector

GSO 2528:2016
 
Gulf Technical Regulation
Cosmetic products – Technical Regulation of cosmetic and personal care products claims
OS GSO 2528:2016
 
Omani Standard
Cosmetic products – Technical Regulation of cosmetic and personal care products claims
GSO 2302:2022
 
Gulf Standard
Cosmetic Products – Face Masks
GSO ISO 11737-1:2020
ISO 11737-1:2018 
Gulf Standard
Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products

Recently Published from Health Sector

GSO ISO 22570:2022
ISO 22570:2020 
Gulf Standard
Dentistry — Spoons and bone curettes
GSO ISO 20695:2022
ISO 20695:2020 
Gulf Standard
Enteral feeding systems — Design and testing
GSO EN 455-2:2022
EN 455-2:2015 
Gulf Standard
Medical gloves for single use - Part 2: Requirements and testing for physical properties
GSO ISO 11193-1:2022
ISO 11193-1:2020 
Gulf Standard
Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution