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)
Hardcopy , PDF
Spanish, Castilian, English
02-17-2010
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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 |
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| 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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