• UNI EN ISO 8359 : 2012

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.

    OXYGEN CONCENTRATORS FOR MEDICAL USE - SAFETY REQUIREMENTS

    Available format(s): 

    Superseded date:  12-09-2022

    Language(s): 

    Published date:  31-12-2011

    Publisher:  Ente Nazionale Italiano di Unificazione (UNI)

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

    Foreword
    Section 1 - General
    Section 2 - Safety requirements
    Section 3 - Protection against electric shock hazards
    Section 4 - Protection against mechanical hazards
    Section 5 - Protection against hazards from unwanted or
                excessive radiation
    Section 6 - Protection against hazards of explosions in
                medically used rooms
    Section 7 - Protection against excessive temperatures and
                other safety hazards
    Section 8 - Accuracy of operating data and protection against
                hazardous output
    Section 9 - Abnormal operation and fault conditions;
                environmental tests
    Section 10 - Constructional requirements
    Section 11 - Additional clauses
    Annexes
    Annex N (normative) - Test apparatus
    Annex P (informative) - Rationale statement
    Annex Q (informative) - Bibliography
    Annex ZA (informative) - Relationship between this
             European Standard and the Essential
             Requirements of EU Directive 93/42/EEC

    Abstract - (Show below) - (Hide below)

    Defines safety requirements for continuous-flow oxygen concentrators.

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

    Document Type Standard
    Publisher Ente Nazionale Italiano di Unificazione (UNI)
    Status Superseded
    Superseded By
    Supersedes

    Standards Referencing This Book - (Show below) - (Hide below)

    ISO 3744:2010 Acoustics Determination of sound power levels and sound energy levels of noise sources using sound pressure Engineering methods for an essentially free field over a reflecting plane
    ISO 9703-1:1992 Anaesthesia and respiratory care alarm signals Part 1: Visual alarm signals
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    IEC 60601-1-2:2014 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    IEC 60651:1979+AMD1:1993+AMD2:2000 CSV Sound level meters
    ISO 9703-2:1994 Anaesthesia and respiratory care alarm signals — Part 2: Auditory alarm signals
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