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Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2- 74:2021)

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Hardcopy , PDF

Language(s)

English

Published date

09-08-2021

Publisher

National Standards Authority of Ireland

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Foreword
Introduction
202 Electromagnetic disturbances — Requirements and tests
206 Usability
208 General requirements, tests and guidance for alarm systems in medical
electrical equipment and medical electrical systems
211 Requirements for medical electrical equipment and medical electrical systems
used in the home healthcare environment
Annex C (informative) Guide to marking and labelling requirements for ME equipment
and ME systems
Annex D (informative) Symbols on marking
Annex AA (informative) Particular guidance and rationale
Annex BB (normative) * Determination of the accuracy of the displayed measured gas
temperature
Annex CC (normative) * Determination of the humidification output
Annex DD (normative) * Specific enthalpy calculations
Annex EE (normative) Removable temperature sensors and mating ports
Annex FF (normative) * Reference temperature sensor
Annex GG (informative) Saturation vapour pressure
Annex HH (informative) Reference to the IMDRF essential principles and labelling
guidances
Annex II (informative) Reference to the essential principles of safety and performance of
medical devices in accordance with ISO 16142-1:2016
Annex JJ (informative) Reference to the general safety and performance requirements
Annex KK (informative) Terminology — Alphabetized index of defined terms
Bibliography

This document applies to the basic safety and essential performance of a humidifier, also hereafter referred to as ME equipment, in combination with its accessories, the combination also hereafter referred to as ME system.

Committee	CEN/TC 215
DocumentType	Standard
Pages	118
ProductNote	The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document. This standard is also refer as ISO 80601-2-90
PublisherName	National Standards Authority of Ireland
Status	Current
Supersedes	I.S. EN ISO 80601-2-74:2020

Standards	Relationship
EN ISO 80601-2-74:2020	Identical
ISO 80601-2-74:2021	Identical

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I.S. EN ISO 80601-2-74:2021

Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2- 74:2021)

Table of Contents

Abstract

General Product Information

International Equivalents

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