• I.S. EN ISO 8359:2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 (ISO 8359:1996)

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-08-2014

    Language(s):  English

    Published date:  01-01-2009

    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
    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)

    Describes safety requirements for continuous-flow oxygen concentrators.

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

    Document Type Standard
    Publisher National Standards Authority of Ireland
    Status Superseded
    Superseded By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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