BS ISO 18250-1:2018

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

BS ISO 18250-1:2018 发布历史

What is this standard about? 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. 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 devic...

BS ISO 18250-1:2018由英国标准学会 GB-BSI 发布于 2018-12-31，并于 2018-12-31 实施。

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BS ISO 18250-1:2018的历代版本如下：

• 2018年 BS ISO 18250-1:2018

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标准号

BS ISO 18250-1:2018

发布

2018年

发布单位

英国标准学会

当前最新

BS ISO 18250-1:2018

 

 

适用范围

What is this standard about? 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. 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 devic...

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