GSO ISO 80601-2-56:2021

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

Diagnostic equipment
Including medical monitoring equipment, medical thermometers and related materials

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 1943:2021
 
Gulf Technical Regulation
Cosmetic Products – Safety Requirements of Cosmetics and Personal Care Products
GSO 2528:2016
 
Gulf Technical Regulation
Cosmetic products – Technical Regulation of cosmetic and personal care products claims
OS GSO 2528:2016
GSO 2528:2016 
Omani Standard
Cosmetic products – Technical Regulation of cosmetic and personal care products claims
GSO 2017:2023
 
Gulf Standard
Personal Care and Baby Wet Wipes

Recently Published from Health Sector

GSO ISO 11193-2:2023
 
Gulf Standard
Single-use medical examination gloves — Part 2: Specification for gloves made from poly(vinyl chloride)
GSO ISO 11193-1:2023
 
Gulf Standard
Single-use medical examination gloves — Part 1: Specification for gloves made from rubber latex or rubber solution
GSO ISO 20184-3:2023
ISO 20184-3:2021 
Gulf Standard
Molecular in vitro diagnostic examinations — Specifications for pre-examination processes for frozen tissue — Part 3: Isolated DNA
GSO ASTM F2193:2023
ASTM F2193:20 
Gulf Standard
Standard Specifications and Test Methods for Components Used in the Surgical Fixation of the Spinal Skeletal System