ISO 18250-1:2018 医疗设备 医疗保健应用储集系统连接器 第1部分：一般要求和通用试验方法

标准编号：ISO 18250-1:2018

中文名称：医疗设备 医疗保健应用储集系统连接器 第1部分：一般要求和通用试验方法

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

发布日期：2018-12

标准范围

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; 1)
— the nipples specified in Annex B of ISO 17256 ; 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.
NOTE 1 Manufacturers are encouraged to incorporate the reservoir connectors specified in the ISO 18250 series into medical devices, medical systems 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 reservoir connectors as specified in the series of standards will be included.

标准预览图