• I.S. EN ISO 80601-2-74:2021

    Current The latest, up-to-date edition.

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

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  09-08-2021

    Publisher:  National Standards Authority of Ireland

    For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.
    Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

    Dates of withdrawal of national standards are available from NSAI.

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    Table of Contents - (Show below) - (Hide below)

    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

    Abstract - (Show below) - (Hide below)

    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.

    General Product Information - (Show below) - (Hide below)

    Committee CEN/TC 215
    Document Type Standard
    Product Note 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
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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