Norm

NEN-ISO 18250-1:2018 en

Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods

163,02 197,25 Incl BTW

Over deze norm

Status Definitief
Aantal pagina's 52
Commissie Transfusie, infusie en injectieapparatuur voor medische toepassingen
Gepubliceerd op 01-12-2018
Taal Engels
NEN-ISO 18250-1 specifies general requirements for reservoir connectors, which convey fluids in healthcare applications. These reservoir connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these reservoir connectors are intended to be used. These healthcare fields of use include, but are not limited to, applications for - respiratory, - enteral, - neural, - intravascular, - citrate-based anticoagulant solution, and - irrigation. Reservoir connectors as specified in this document are non-interconnectable with: - the reservoir connectors of every other application specified in the ISO 18250 series; - removable temperature sensor port specified in Annex EE of ISO 80601-2-74:2017; - the nipples specified in Annex B of ISO 172561); unless otherwise specified in the ISO 18250 series. Application parts of the ISO 18250 series can specify additional connectors with which reservoir connectors (as specified in those application parts) are to be non-interconnectable. This document provides the methodology to assess non-interconnectable characteristics of reservoir connectors based on their inherent design and dimensions in order to reduce the risk of misconnections between medical devices or between accessories for different applications. This document does not specify requirements for the medical devices or accessories that use these reservoir connectors. Such requirements are given in particular International Standards for specific medical devices or accessories.

Details

ICS-code 11.040.25
Engelse titel Medical devices - Connectors for reservoir delivery systems for healthcare applications - Part 1: General requirements and common test methods

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