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  • BS EN ISO 17510-1:2009

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by

    Sleep apnoea breathing therapy Sleep apnoea breathing therapy equipment

    Available format(s):  Hardcopy, PDF

    Superseded date:  30-11-2020

    Language(s):  English

    Published date:  30-04-2009

    Publisher:  British Standards Institution

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Requirements
    5 Classification and designation
    6 Marking, labelling and packaging
    7 Power input
    8 Basic safety categories
    9 Removable protective means
    10 Environmental conditions
    13 General
    14 Requirements related to classification
    15 Limitation of voltage and/or energy
    16 Enclosures and protective covers
    17 Separation
    18 Protective earthing, functional earthing and potential
       equalization
    19 Continuous leakage currents and patient auxiliary
       currents
    20 Dielectric strength
    21 Mechanical strength
    22 Moving parts
    23 Surfaces, corners and edges
    24 Stability in normal use
    25 Expelled parts
    26 Vibration and noise
    27 Pneumatic and hydraulic power
    28 Suspended masses
    29 X-radiation
    30 Alpha, beta, gamma, neutron radiation and other particle
       radiation
    31 Microwave radiation
    32 Light radiation (including lasers)
    33 Infra-red radiation
    34 Ultra-violet radiation
    35 Acoustical energy (including ultra-sonics)
    36 Electromagnetic compatibility
    37 Locations and basic requirements
    38 Marking, accompanying documents
    39 Common requirements for Category AP and Category APG
       equipment
    40 Requirements and tests for category AP equipment, parts
       and components thereof
    41 Requirements and tests for category APG equipment, parts
       and components thereof
    41 Requirements and tests for category APG equipment, parts
       and components thereof
    42 Excessive temperatures
    43 Fire prevention
    44 Overflow, spillage, leakage, humidity, ingress of liquids,
       cleaning, sterilization and disinfection
    45 Pressure vessels and parts subject to pressure
    46 Human errors
    47 Electrostatic charges
    48 Biocompatibility
    49 Interruption of the power supply
    50 Accuracy of operating data
    51 Protection against hazardous output
    52 Abnormal operation and fault conditions
    53 Environmental tests
    54 General
    55 Enclosures and covers
    56 Components and general assembly
    57 Mains parts, components and layout
    58 Protective earthing - Terminals and connections
    59 Construction and layout
    Annex AA (informative) - Rationale
    Annex BB (normative) - Pressure accuracy in normal use
             test methods
    Annex CC (normative) - Maximum flowrate test method
    Annex DD (informative) - Environmental aspects
    Annex EE (informative) - Reference to the essential
             principles
    Annex FF (informative) - Terminology - Alphabetized
             index of defined terms
    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 requirements for equipment intended for sleep apnoea breathing therapy for domiciliary use, ships, aircraft and other transport vehicles and for use in healthcare institutions.

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

    Committee CH/121/5
    Development Note To be read in conjunction with BS EN 60601-1. Supersedes 98/565246 DC (03/2002) Supersedes 08/30192505 DC. (04/2009)
    Document Type Standard
    Publisher British Standards Institution
    Status Superseded
    Superseded By
    Supersedes

    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 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
    ISO/TS 17665-2:2009 Sterilization of health care products — Moist heat — Part 2: Guidance on the application of ISO 17665-1
    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
    ISO 14937:2009 Sterilization of health care products General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices
    NFPA 53 : 2016 MATERIALS, EQUIPMENT, AND SYSTEMS USED IN OXYGEN-ENRICHED ATMOSPHERES
    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
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    ISO 11135-1:2007 Sterilization of health care products Ethylene oxide Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices
    ISO 32:1977 Gas cylinders for medical use — Marking for identification of content
    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 5359:2014 Anaesthetic and respiratory equipment Low-pressure hose assemblies for use with medical gases
    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
    ISO 23328-2:2002 Breathing system filters for anaesthetic and respiratory use — Part 2: Non-filtration aspects
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    ISO 23328-1:2003 Breathing system filters for anaesthetic and respiratory use — Part 1: Salt test method to assess filtration performance
    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
    ISO 9170-1:2017 Terminal units for medical gas pipeline systems — Part 1: Terminal units for use with compressed medical gases and vacuum
    ISO/TS 11135-2:2008 Sterilization of health care products Ethylene oxide Part 2: Guidance on the application of ISO 11135-1
    ISO 14971:2007 Medical devices Application of risk management to medical devices
    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
    IEC 60601-2-12:2001 Medical electrical equipment - Part 2-12: Particular requirements for the safety of lung ventilators - Critical care ventilators
    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
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    IEC 60601-1-4:1996+AMD1:1999 CSV Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems
    ISO 17664:2017 Processing of health care products Information to be provided by the medical device manufacturer for the processing of medical devices
    ISO 17510-2:2007 Sleep apnoea breathing therapy Part 2: Masks and application accessories
    ISO 17665-1:2006 Sterilization of health care products — Moist heat — Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices
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