• There are no items in your cart

UNE-EN ISO 26782:2010

Current
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

02-17-2010

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

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.

Committee
CTN 110
DocumentType
Standard
Pages
38
PublisherName
Asociacion Espanola de Normalizacion
Status
Current

Standards Relationship
EN ISO 26782:2009 Identical
ISO 26782:2009 Identical
EN ISO 26782:2009/AC:2009 Identical

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

View more information
US$83.31
Excluding Tax where applicable

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, flexible and cost effective.