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  • 13/30254355 DC : 0

    NA Status of Standard is Unknown

    BS ISO 80601-2-70 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-70: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF SLEEP APNEOA BREATHING THERAPY EQUIPMENT

    Available format(s):  Hardcopy, PDF

    Language(s):  English

    Published date: 

    Publisher:  British Standards Institution

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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 Medical electrical equipment - Part 1-2: General requirements
        for basic safety and essential performance
        - Collateral standard: Electromagnetic
        compatibility - Requirements and tests
    206 Medical electrical equipment - Part 1-6: General requirements
        for basic safety and essential performance - Collateral
        Standard: Usability
    208 Medical electrical equipment - Part 1-8: General requirements
        for basic safety and essential performance - Collateral
        Standard: General requirements, tests and guidance
        for alarm systems in medical electrical equipment
        and medical electrical systems
    211 Medical electrical equipment - Part 1-11: General requirements
        for basic safety and essential performance - Collateral
        Standard: 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 Essential Principles
    Bibliography
    Alphabetized index of defined terms used in this particular standard
    Annex ZA (informative) - Relationship between this Document and
             the Essential Requirements of EU Directive 93/42/EEC

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

    Comment Closes On
    Committee CH/121/5
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    ISO 4871:1996 Acoustics — Declaration and verification of noise emission values of machinery and equipment
    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 80601-2-13:2011 Medical electrical equipment Part 2-13: Particular requirements for basic safety and essential performance of an anaesthetic workstation
    EN 15986:2011 Symbol for use in the labelling of medical devices - Requirements for labelling of medical devices containing phthalates
    ISO 10651-2:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 2: Home care ventilators for ventilator-dependent patients
    ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1-6:2010+AMD1:2013 CSV Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    ISO 10651-4:2002 Lung ventilators — Part 4: Particular requirements for operator-powered resuscitators
    IEC 60601-1-8:2006+AMD1:2012 CSV Medical electrical equipment - Part 1-8: General requirements forbasic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems inmedical electrical equipment and medical electrical systems
    IEC 62366:2007+AMD1:2014 CSV Medical devices - Application of usability engineering to medical devices
    ISO 80601-2-12:2011 Medical electrical equipment Part 2-12: Particular requirements for basic safety and essential performance of critical care ventilators
    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
    ISO 10651-3:1997 Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
    ISO 8185:2007 Respiratory tract humidifiers for medical use Particular requirements for respiratory humidification systems
    ISO/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    IEC 62304:2006+AMD1:2015 CSV Medical device software - Software life cycle processes
    ISO 14159:2002 Safety of machinery — Hygiene requirements for the design of machinery
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    IEC 60601-1-3:2008+AMD1:2013 CSV Medical electrical equipment - Part 1-3: General requirements forbasic safety and essential performance - Collateral Standard: Radiation protection in diagnostic X-ray equipment
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    ISO 17510:2015 Medical devices — Sleep apnoea breathing therapy — Masks and application accessories
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    DIN 45681:2005-03 ACOUSTICS - DETERMINATION OF TONAL COMPONENTS OF NOISE AND DETERMINATION OF A TONE ADJUSTMENT FOR THE ASSESSMENT OF NOISE IMMISSIONS
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
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