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  • NF EN ISO 17510-1 : 2009

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.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 1: SLEEP APNOEA BREATHING THERAPY EQUIPMENT

    Available format(s): 

    Superseded date:  22-10-2021

    Language(s): 

    Published date:  12-01-2013

    Publisher:  Association Francaise de Normalisation

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

    Avant-propos
    Introduction
    1 Domaine d'application
    2 Références normatives
    3 Termes et définitions
    4 Exigences
    5 Classification et désignation
    6 Marquage, étiquetage et emballage
    7 Puissance absorbée
    8 Catégories fondamentales de sécurité
    9 Moyens de protection amovibles
    10 Conditions d'environnement
    11 Non utilisé
    12 Non utilisé
    13 Généralités
    14 Exigences relatives à la classification
    15 Limitation de la tension et/ou de l'énergie
    16 Enveloppes et capots de protection
    17 Séparation
    18 Mise à la terre de protection, mise à la terre
       fonctionnelle et égalisation des potentiels
    19 Courants de fuite permanents et courant auxiliaire
       patient
    20 Tension de tenue
    21 Résistance mécanique
    22 Parties en mouvement
    23 Surfaces, angles et arêtes
    24 Stabilité en utilisation normale
    25 Projection d'objets
    26 Vibrations et bruit
    27 Puissance pneumatique et puissance hydraulique
    28 Masses suspendues
    29 Rayonnements X
    30 Rayonnements alpha, bêta, gamma, neutroniques et
       d'autres particules
    31 Rayonnements à micro-ondes
    32 Rayonnements lumineux (y compris les rayonnements
       lasers)
    33 Rayonnements infrarouges
    34 Rayonnements ultraviolets
    35 Énergie acoustique (y compris les ultrasons)
    36 Compatibilité électromagnétique
    37 Localisations et exigences fondamentales
    38 Marquage et documents d'accompagnement
    39 Exigences communes aux appareils de la catégorie
       AP et de la catégorie APG
    40 Exigences et essais pour les appareils de la catégorie
       AP, parties et composants de ceux-ci
    41 Exigences et essais pour les appareils de la catégorie
       APG, parties et composants de ceux-ci
    42 Températures excessives
    43 Prévention du feu
    44 Débordements, renversements, fuites, humidité,
       pénétration de liquides, nettoyage, stérilisation
       et désinfection
    45 Réservoirs et parties sous pression
    46 Erreurs humaines
    47 Charges électrostatiques
    48 Biocompatibilité
    49 Coupure de l'alimentation électrique
    50 Précision des caractéristiques de fonctionnement
    51 Protection contre les caractéristiques de sortie
       présentant des risques
    52 Fonctionnement anormal et conditions de défauts
    53 Essais d'environnement
    54 Généralités
    55 Enveloppes et capots
    56 Composants et ensembles
    57 Parties reliées au réseau, composants et montage
    58 Mise à la terre de protection - Bornes et raccordements
    59 Construction et montage
    Annexe AA (informative) Exposé des motifs
    Annexe BB (normative) Méthodes d'essai portant sur
              l'exactitude de la pression en utilisation
              normale
    Annexe CC (normative) Méthode d'essai du débit maximal
    Annexe DD (informative) Aspects environnementaux
    Annexe EE (informative) Référence aux principes essentiels
    Annexe FF (informative) Terminologie - Index alphabétique
              des termes définis
    Bibliographie

    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)

    Development Note Indice de classement: S95-182-1. Supersedes NFS 95 182. (09/2003) PR NF EN ISO 17510-1 January 2006. (01/2006) PR NF EN ISO 17510-1 January 2009. (01/2009)
    Document Type Standard
    Publisher Association Francaise de Normalisation
    Status Superseded
    Superseded By
    Supersedes

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

    NF EN 60601-1-6 : 2010 AMD 1 2015 MEDICAL ELECTRICAL EQUIPMENT - PART 1-6: GENERAL REQUIREMENTS FOR BASIC SAFETY AND ESSENTIAL PERFORMANCE - COLLATERAL STANDARD: USABILITY
    NF EN ISO 5356-1 : 2015 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 1: CONES AND SOCKETS
    NF EN ISO 11135 : 2012 PR STERILIZATION OF HEALTH CARE PRODUCTS - ETHYLENE OXIDE - REQUIREMENTS FOR DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    NF EN ISO 3744 : 2012 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
    NF EN ISO 23328-1 : 2008 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 1: SALT TEST METHOD TO ASSESS FILTRATION PERFORMANCE
    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    NF EN ISO 23328-2 : 2009 BREATHING SYSTEM FILTERS FOR ANAESTHETIC AND RESPIRATORY USE - PART 2: NON-FILTRATION ASPECTS
    NF EN ISO 5356-2 : 2013 ANAESTHETIC AND RESPIRATORY EQUIPMENT - CONICAL CONNECTORS - PART 2: SCREW-THREADED WEIGHT-BEARING CONNECTORS
    NF EN ISO 9170-1 : 2008 TERMINAL UNITS FOR MEDICAL GAS PIPELINE SYSTEMS - PART 1: TERMINAL UNITS FOR USE WITH COMPRESSED MEDICAL GASES AND VACUUM
    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
    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
    NF EN 60529 : 92 AMD 2 2014 DEGREES OF PROTECTION PROVIDED BY ENCLOSURES (IP CODE)
    ISO 32:1977 Gas cylinders for medical use Marking for identification of content
    NF EN 60601-1-2 : 2016 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 Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
    NF EN 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/TR 16142:2006 Medical devices Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
    NFT 20 037 : 1985 CHEMICAL PRODUCTS OF INDUSTRIAL USE - DETERMINATION OF TEMPERATURE OF AUTO-INFLAMMATION OF VOLATILE LIQUIDS AND GASES
    IEC 60529:1989+AMD1:1999+AMD2:2013 CSV Degrees of protection provided by enclosures (IP Code)
    NF EN ISO 4871 : 2009 ACOUSTICS - DECLARATION AND VERIFICATION OF NOISE EMISSION VALUES OF MACHINERY AND EQUIPMENT
    NF EN ISO 4135 : 2001 ANAESTHETIC AND RESPIRATORY EQUIPMENT - VOCABULARY
    NF EN ISO 8185 : 2009 RESPIRATORY TRACT HUMIDIFIERS FOR MEDICAL USE - PARTICULAR REQUIREMENTS FOR RESPIRATORY HUMIDIFICATION SYSTEMS
    NF EN ISO 17510-2 : 2009 SLEEP APNOEA BREATHING THERAPY - PART 2: MASKS AND APPLICATION ACCESSORIES
    NF EN ISO 17665 : 2004 PR STERILIZATION OF HEALTH CARE PRODUCTS - MOIST HEAT - DEVELOPMENT, VALIDATION AND ROUTINE CONTROL OF A STERILIZATION PROCESS FOR MEDICAL DEVICES
    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
    NF EN 60601-1-1 : 2001 MEDICAL ELECTRICAL EQUIPMENT - PART 1-1: GENERAL REQUIREMENTS FOR SAFETY - COLLATERAL STANDARD: SAFETY REQUIREMENTS FOR MEDICAL ELECTRICAL SYSTEMS
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