SS-EN-ISO-80369-1 Small-bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2018)

SS-EN-ISO-80369-1 - 2018 EDITION - CURRENT
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This document specifies general requirements for small-bore connectors, which convey liquids or gases in healthcare applications. These small-bore connectors are used in medical devices or accessories intended for use with a patient. This document also specifies the healthcare fields in which these small-bore connectors are intended to be used. These healthcare fields include, but are not limited to: — breathing systems and driving gases; — enteral; — limb cuff inflation; — neuraxial; — intravascular or hypodermic. This document provides the methodology to assess non-interconnectable characteristics of small-bore 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 as specified in this document as well as those that will be developed under future parts of the ISO 80369 series. This document does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Clause 7 allows for additional designs of small-bore connectors for new applications for inclusion in the ISO 80369 series. NOTE 2 Manufacturers are encouraged to incorporate the small-bore connectors specified in the ISO 80369 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, the risks associated with changing to the new small-bore connectors as specified in the ISO 80369 series of standards will be considered. NOTE 3 The connectors specified in the ISO 80369 series are intended for use only in their specified application. Use of these connectors for other applications increases risk that a hazardous misconnection could occur. NOTE 4 Manufact...

To find similar documents by classification:

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Medical devices

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Designation Name

SS-EN ISO 80369-1:2018

Revision Level

2018 EDITION

Status

Current

Publication Date

Nov. 27, 2018

Language(s)

English

Page Count

48

International Equivalent

EN ISO 80369-1:2018(IDT); ISO 80369-1:2018(IDT)