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

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 17256[1];

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 t