標準號：DIN EN ISO 80369-1-2011
中文標準名稱：衛生保健應用中液體和氣體用小口徑連接器.第1部分:一般要求(ISO 80369-1-2010);德文版本EN ISO 80369-1-2010
英文標準名稱：Small bore connectors for liquids and gases in healthcare applications - Part 1: General requirements (ISO 80369-1:2010); German version EN ISO 80369-1:2010
標準類型：C47
發布日期：1999/12/31 12:00:00
實施日期：1999/12/31 12:00:00
中國標準分類號：C47
國際標準分類號：11.040.10;11.040.20
適用范圍：This part of ISO 80369 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 International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS are intended to be used.These healthcare fields of use include, but are not limited to, Applications for:- Breathing systems and driving gases,- entereal and gastric,- urethreal and urinary,- limb cuff inflation,- neuraxial devices, and- intravascular or hypodermic.SMALL-BORE CONNECTORS as specified in this International Standard are NON-INTERCONNECTABLE with:- the cones and sockets of ISO 5356-1:2004 and ISO 5356-2:2006;- the temperature sensor CONNCETOR and mating ports specified in Annex DD of ISO 8185:2007; and- the nipples of EN 13544-2:2002This International Standard provides the methodology to assess NON-INTERCONNCETABLE characteristics of SMALL-BORE CONNCETORS based on their inherent design and dimensions in order to reduce the Risk of medical devices or between accessories for different applications and to reduce the risk of miconnections between mical devices with 6% Luer Connectors, and all other non-Luer connectors that will be developed under future parts of this series of standards.It does not specify requirements for the medical devices or accessories that use these small-bore connectors. Such requirements are given in particular Internatioanl Standards for specific medical devices or accessories.