ISO 80369-3:2016
2016-07
Resumen
ISO 80369-3:2016 specifies the dimensions and requirements for the design and functional performance of small-bore connectors intended to be used for connections on enteral medical devices and accessories.
NOTE 1 Enteral medical devices include enteral feeding sets, enteral drainage sets, enteral syringes, and patient interface devices including access ports.
It does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.
It does not specify requirements for small-bore connectors that are used for the following:
- gastric suction-only medical devices;
- oral-only medical devices;
EXAMPLE An oral tip syringe that is not intended to connect to another medical device. It is intended to administer directly to the patient's mouth.
- pressurizing and depressurizing the retention mechanism (e.g. balloon) used to hold invasive enteral medical devices in place;
- medical devices for rectal drainage, rectal administration of medicines or fluid, and any other rectal access medical device;
- gastrointestinal endoscopy equipment;
- skin level gastrostomy medical devices.
NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in ISO 80369-3 :2016 into enteral medical devices or accessories, even if currently not required by the relevant particular medical device standards. It is expected that when the relevant particular medical device standards are revised, requirements for small-bore connectors, as specified in ISO 80369, will be included.
Informaciones generales
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Estado: PublicadoFecha de publicación: 2016-07Etapa: Norma Internacional confirmada [90.93]
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Edición: 1Número de páginas: 39
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Comité Técnico :ISO/TC 210ICS :11.040.25
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Modificaciones
Las enmiendas se emiten cuando se decide que puede ser necesario agregar nuevo material a un documento de normalización existente. También pueden incluir correcciones editoriales o técnicas que deban aplicarse al documento existente.
Amendment 1
Edición 2019
Ciclo de vida
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Ahora
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Preliminar
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Propuesta
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Preparación
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Comité
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Consulta
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Aprobación
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Publicación
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90
Revisión
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Retirada
Modificaciones
Aportan contenido adicional; disponible para su compra; no incluidas en el texto de la norma existente.PublicadoISO 80369-3:2016/Amd 1:2019
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