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  • UNE-EN ISO 26782:2010

    Current The latest, up-to-date edition.

    Anaesthetic and respiratory equipment - Spirometers intended for the measurement of time forced expired volumes in humans (ISO 26782:2009)

    Available format(s):  Hardcopy, PDF

    Language(s):  Spanish, Castilian, English

    Published date:  17-02-2010

    Publisher:  Asociacion Espanola de Normalizacion

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

    PROLOGO
    INTRODUCCION
    1 OBJETO Y CAMPO DE APLICACION
    2 NORMAS PARA CONSULTA
    3 TÉRMINOS Y DEFINICIONES
    4 REQUISITOS GENERALES
    5 IDENTIFICACION, MARCADO Y DOCUMENTOS
    6 RANGO DE MEDICION
    7 REQUISITOS DE FUNCIONAMIENTO
    8 REQUISITOS DE CONSTRUCCION
    9 LIMPIEZA, ESTERILIZACION Y DESINFECCION
    10 BIOCOMPATIBILIDAD
    ANEXO A (Informativo) - JUSTIFICACION
    ANEXO B (Normativo) - ENSAYO DE LA EXACTITUD, LINEALIDAD E
            IMPEDANCIA DE LOS ESPIROMETROS
    ANEXO C (Normativo) - PERFILES DE ENSAYO DEFINIDOS
    ANEXO D (Informativo) - ASPECTOS AMBIENTALES
    ANEXO E (Informativo) - REFERENCIA A LOS PRINCIPIOS ESENCIALES
    BIBLIOGRAFIA
    INDICE ALFABÉTICO DE LOS TÉRMINOS DEFINIDOS UTILIZADOS EN ESTA
    NORMA INTERNACIONAL
    ANEXO ZA (Informativo) - CAPITULOS DE ESTA NORMA EUROPEA
             RELACIONADOS CON LOS REQUISITOS ESENCIALES U OTRAS
             DISPOSICIONES DE LA DIRECTIVA 93/42/CEE

    Abstract - (Show below) - (Hide below)

    Esta norma internacional especifica los requisitos para los ESPIROMETROS previstos para la evaluación de la función pulmonar en humanos que pesen más de 10 kg.

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

    Committee CTN 110
    Document Type Standard
    Publisher Asociacion Espanola de Normalizacion
    Status Current

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

    IEC 60601-1:2005+AMD1:2012 CSV Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    ISO 23747:2015 Anaesthetic and respiratory equipment Peak expiratory flow meters for the assessment of pulmonary function in spontaneously breathing humans
    ISO 13485:2016 Medical devices Quality management systems Requirements for regulatory purposes
    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
    PD 6461-1:1995 General metrology Basic and general terms (VIM)
    ISO 14971:2007 Medical devices Application of risk management to 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
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