Skip to content
Please enter a keyword to search

  • BS EN ISO 17510-2:2009

    View superseded by
    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
    View superseded by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

    Available format(s):  Hardcopy, PDF

    Superseded date:  19-02-2020

    Language(s):  English

    Published date:  30-04-2009

    Publisher:  British Standards Institution

    Add To Cart

    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)

    Applicable to masks, their fixing and to the accessories used to connect a sleep apnoea breathing therapy equipment to the patient.

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

    Committee CH/121/5
    Development Note Supersedes 01/560291 DC (02/2003) Supersedes 06/30127484 DC. (11/2007) Supersedes 08/30192480 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    Status Superseded
    Superseded By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
    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
    View more information

    • Access your standards online with a subscription

      Features

      • Simple online access to standards, technical information and regulations
      • Critical updates of standards and customisable alerts and notifications
      • Multi - user online standards collection: secure, flexibile and cost effective