Norm

NEN-EN-ISO 80369-3:2016 en

Connectors met een kleine diameter voor vloeistoffen en gassen in medische toepassingen - Deel 3: Connectoren voor enterale toepassingen

143,10

Over deze norm

Status Definitief
Aantal pagina's 39
Commissie Medische hulpmiddelen - horizontale onderwerpen
Gepubliceerd op 01-08-2016
Taal Engels
NEN-EN-ISO 80369-3 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. This part of ISO 80369 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. This part of ISO 80369 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.

Details

ICS-code 11.040.25
Nederlandse titel Connectors met een kleine diameter voor vloeistoffen en gassen in medische toepassingen - Deel 3: Connectoren voor enterale toepassingen
Engelse titel Small-bore connectors for liquids and gases in healthcare applications - Part 3: Connectors for enteral applications
Normatieve verwijzingen
  • 93/42/EEG, Medische hulpmiddelen

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