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    I.S. EN ISO 80601-2-70:2020

    Current The latest, up-to-date edition.

    Medical electrical equipment - Part 2-70: Particular requirements for the basic safety and essential performance of sleep apnoea breathing therapy equipment (ISO 80601-2-70:2020)

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date:  14-12-2020

    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
    201.1 * Scope, object and related standards
    201.2 Normative references
    201.3 Terms and definitions
    201.4 General requirements
    201.5 General requirements for testing of ME equipment
    201.6 Classification of ME equipment and ME systems
    201.7 ME equipment identification, marking and documents
    201.8 Protection against electrical hazards from ME equipment
    201.9 Protection against mechanical hazards of ME equipment and ME systems
    201.10 Protection against unwanted and excessive radiation hazards
    201.11 Protection against excessive temperatures and other hazards
    201.12 Accuracy of controls and instruments and protection against hazardous outputs
    201.13 Hazardous situations and fault conditions
    201.14 Programmable electrical medical systems (PEMS)
    201.15 Construction of ME equipment
    201.16 ME systems
    201.17 Electromagnetic compatibility of ME equipment and ME systems
    201.101 Breathing gas pathway connectors
    201.102 Requirements for the breathing gas pathway and accessories
    201.103 Functional connection
    201.104 Training
    202 Electromagnetic disturbances — Requirements and tests
    206 Usability
    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 (informative) Data interface requirements
    Annex CC (informative) Reference to the IMDRF essential principles and labelling guidances
    Annex DD (informative) Reference to the essential principles
    Annex EE (informative) Reference to the general safety and performance requirements
    Annex FF (informative) Terminology — alphabetized index of defined terms
    Bibliography

    Abstract - (Show below) - (Hide below)

    IEC 60601‐1:2005+Amendment 1:2012, 1.1 is replaced by: This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.

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

    Committee TC 121
    Document Type Standard
    Product Note THIS STANDARD IS REFERS TO : IEC 60601‐1:2005+AMD1:2012+AMD2:2020,ISO 5356‐1,ISO 16142‐1:2016,ISO 16142‐1:,ISO 18562‐1,ISO 80369‐1,ISO 80601‐2‐12,ISO 80601‐2‐74,IEC 60601‐1:,ISO/IEEE 11073‐10424,ISO 18562‐2,ISO 80601‐2‐13,ISO 80601‐2‐72,ISO 80601‐2‐79,ISO 80601‐2‐80,ISO 80601‐2‐84,ISO 80601‐2‐87 The date of any NSAI previous adoption may not match the date of its original CEN/CENELEC document.
    Publisher National Standards Authority of Ireland
    Status Current
    Supersedes
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