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NEN-EN-ISO 80601-2-56/A1

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

active, Most Current
Organization: NEN
Publication Date: 1 May 2020
Status: active
Page Count: 16
ICS Code (Temperature-measuring instruments): 17.200.20
ICS Code (Diagnostic equipment): 11.040.55
scope:

ME EQUIPMENT that measures and displays a BODY TEMPERATURE is inside the scope of this document.

EXAMPLE 1 ME EQUIPMENT using ACCESSORIES such as a pulmonary artery catheter for the determination of cardiac output by thermodilution is in the scope of this document if it displays a BODY TEMPERATURE.

EXAMPLE 2 ME EQUIPMENT using ACCESSORIES such as a Foley catheter that includes a temperature PROBE is in the scope of this document.

Document History

NEN-EN-ISO 80601-2-56/A1
May 1, 2020
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
ME EQUIPMENT that measures and displays a BODY TEMPERATURE is inside the scope of this document. EXAMPLE 1 ME EQUIPMENT using ACCESSORIES such as a pulmonary artery catheter for the determination of...
August 1, 2017
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement
NEN-EN- ISO 80601-2-56 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...
October 1, 2012
Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement (ISO 80601-2-56:2009)
This International Standard applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a CLINICAL THERMOMETER in combination with its ACCESSORIES, hereafter referred to as ME EQUIPMENT. This standard...
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