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5. Scope of the proposed work item (max 4000 characters)
From ISO 18250-1:2018:
This document 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.
Reģistrācijas numurs (WIID)
77022
Darbības sfēra
5. Scope of the proposed work item (max 4000 characters)
From ISO 18250-1:2018:
This document 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.
