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  • EN ISO 17510-2:2009

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    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Sleep apnoea breathing therapy - Part 2: Masks and application accessories (ISO 17510-2:2007)

    Available format(s): 

    Superseded date:  30-03-2022

    Language(s): 

    Published date:  11-03-2009

    Publisher:  Comite Europeen de Normalisation

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

    Foreword
    Introduction
    1 Scope
    2 Normative references
    3 Terms and definitions
    4 Information to be supplied by the manufacturer
    5 Construction requirements
      5.1 Mask connectors
      5.2 Biocompatibility
      5.3 Protection against rebreathing
      5.4 Cleaning, disinfection and sterilization
      5.5 Breathing during single fault condition
      5.6 Breathing system filter
    6 Vibration and noise
    Annex A (informative) - Rationale
    Annex B (normative) - Exhaust flow test procedure
    Annex C (normative) - Resistance to flow (pressure
            drop)
    Annex D (normative) - Anti-asphyxia valve pressure
            testing
    Annex E (normative) - Breathing during single fault
            condition - Determination of the inspiratory
            and expiratory resistance
    Annex F (normative) - CO[2] rebreathing
    Annex G (normative) - Vibration and noise
    Annex H (informative) - Guide to information to be
            supplied by the manufacturer
    Annex I (informative) - Reference to the essential
            principles
    Annex J (informative) - Environmental aspects
    Annex K (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)

    ISO 17510-2:2007 applies to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient. It specifies requirements for masks and accessories, including any connecting element, that are required to connect the patient connection port of sleep apnoea breathing therapy equipment to a patient, and are used for the application of sleep apnoea breathing therapy, e.g. nasal masks, exhaust ports and headgear.ISO 17510-2:2007 does not cover oral appliances.

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

    Committee CEN/TC 215
    Development Note Supersedes PREN ISO 17510-2. (08/2009)
    Document Type Standard
    Publisher Comite Europeen de Normalisation
    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
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 17510-1:2007 Sleep apnoea breathing therapy Part 1: Sleep apnoea breathing therapy equipment
    ISO 5356-1:2015 Anaesthetic and respiratory equipment Conical connectors Part 1: Cones and sockets
    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
    ISO 5356-2:2012 Anaesthetic and respiratory equipment — Conical connectors — Part 2: Screw-threaded weight-bearing connectors
    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
    AAMI TIR 12 : 2010 DESIGNING, TESTING, AND LABELING REUSABLE MEDICAL DEVICES FOR REPROCESSING IN HEALTH CARE FACILITIES: A GUIDE FOR MEDICAL DEVICE MANUFACTURERS
    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 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
    IEC 60601-1-1:2000 Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems
    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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