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    NA Status of Standard is Unknown

    BS ISO 80601-2-80 - MEDICAL ELECTRICAL EQUIPMENT - PART 2-80: PARTICULAR REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE OF VENTILATORY SUPPORT EQUIPMENT FOR VENTILATORY INSUFFICIENCY

    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
    European 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
            for ME EQUIPMENT
    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 Gas connections
    201.102 Requirements for the VBS and ACCESSORIES
    201.103 Spontaneous breathing during loss of power
            supply
    201.104 Training
    201.105 Indication of duration of operation
    201.106 FUNCTIONAL CONNECTION
    201.107 Display loops
    201.108 POWER SUPPLY CORDS
    201.109 VENTILATORY SUPPORT EQUIPMENT security
    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 (informative) - Data interface requirements
    Annex CC (informative) - Reference to the ESSENTIAL PRINCIPLES
    Annex DD (informative) - Terminology - Alphabetized index of
             defined terms
    Annex ZA (informative) - Relationship between this Document
             and the Essential Requirements of EU Directive 93/42/EEC
    Bibliography

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

    Comment Closes On
    Committee CH/121/9
    Document Type Draft
    Publisher British Standards Institution
    Status NA

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

    EN ISO 5367:2014 ANAESTHETIC AND RESPIRATORY EQUIPMENT - BREATHING SETS AND CONNECTORS (ISO 5367:2014)
    ISO 8836:2014 Suction catheters for use in the respiratory tract
    ISO 4871:1996 Acoustics Declaration and verification of noise emission values of machinery and equipment
    ISO 80601-2-74:2017 Medical electrical equipment Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying 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 639-1:2002 Codes for the representation of names of languages Part 1: Alpha-2 code
    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 18562-1:2017 Biocompatibility evaluation of breathing gas pathways in healthcare applications Part 1: Evaluation and testing within a risk management process
    ISO 10651-6:2004 Lung ventilators for medical use Particular requirements for basic safety and essential performance Part 6: Home-care ventilatory support devices
    EN ISO 5356-1:2015 Anaesthetic and respiratory equipment - Conical connectors - Part 1: Cones and sockets (ISO 5356-1:2015)
    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 16142-1:2016 Medical devices Recognized essential principles of safety and performance of medical devices Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
    EN 60601-1-6:2010/A1:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY (IEC 60601-1-6:2010/A1:2013)
    EN ISO 9360-2:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml (ISO 9360-2:2001)
    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
    EN ISO 23328-2:2009 Breathing system filters for anaesthetic and respiratory use - Part 2: Non-filtration aspects (ISO 23328-2:2002)
    ISO 5367:2014 Anaesthetic and respiratory equipment Breathing sets and connectors
    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
    EN 60601-1-2:2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-2: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: ELECTROMAGNETIC DISTURBANCES - REQUIREMENTS AND TESTS (IEC 60601-1-2:2014)
    ISO 10651-3:1997 Lung ventilators for medical use Part 3: Particular requirements for emergency and transport ventilators
    ISO 80601-2-72:2015 Medical electrical equipment Part 2-72: Particular requirements for basic safety and essential performance of home healthcare environment ventilators for ventilator-dependent patients
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    EN 61672-1:2013 ELECTROACOUSTICS - SOUND LEVEL METERS - PART 1: SPECIFICATIONS (IEC 61672-1:2013)
    IEC TR 60878:2015 Graphical symbols for electrical equipment in medical practice
    EN 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 3744:2010)
    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
    EN ISO 7396-1:2016 Medical gas pipeline systems - Part 1: Pipeline systems for compressed medical gases and vacuum (ISO 7396-1:2016)
    ISO 80369-1:2010 Small-bore connectors for liquids and gases in healthcare applications Part 1: General requirements
    EN ISO 9360-1:2009 Anaesthetic and respiratory equipment - Heat and moisture exchangers (HMEs) for humidifying respired gases in humans - Part 1: HMEs for use with minimum tidal volumes of 250 ml (ISO 9360-1:2000)
    ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications Part 7: Connectors for intravascular or hypodermic applications
    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 9000:2015 Quality management systems Fundamentals and vocabulary
    ISO 9360-1:2000 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 1: HMEs for use with minimum tidal volumes of 250 ml
    EN ISO 4871 : 2009 ACOUSTICS - DECLARATION AND VERIFICATION OF NOISE EMISSION VALUES OF MACHINERY AND EQUIPMENT (ISO 4871:1996)
    ISO 7000:2014 Graphical symbols for use on equipment Registered symbols
    ISO 4135:2001 Anaesthetic and respiratory equipment Vocabulary
    ISO 9360-2:2001 Anaesthetic and respiratory equipment — Heat and moisture exchangers (HMEs) for humidifying respired gases in humans — Part 2: HMEs for use with tracheostomized patients having minimum tidal volumes of 250 ml
    ISO 15223-1:2016 Medical devices Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
    EN 60601-1-11:2015 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 (IEC 60601-1-11:2015)
    EN ISO 23328-1 : 2008 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE
    EN 60601-1-8:2007/A11:2017 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 (IEC 60601-1-8:2006/A1:2012)
    ISO 7396-1:2016 Medical gas pipeline systems Part 1: Pipeline systems for compressed medical gases and vacuum
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