標(biāo)準(zhǔn)號：BS EN ISO 80369-1-2010
中文標(biāo)準(zhǔn)名稱：衛(wèi)生健康設(shè)施中液體和氣體用小型孔連接器.一般要求
英文標(biāo)準(zhǔn)名稱：Small bore connectors for liquids and gases in healthcare applications. General requirements
標(biāo)準(zhǔn)類型：C31
發(fā)布日期：2011/7/31 12:00:00
實施日期：2011/7/31 12:00:00
中國標(biāo)準(zhǔn)分類號：C31
國際標(biāo)準(zhǔn)分類號：11.040.10;11.040.20
引用標(biāo)準(zhǔn)：ISO 5356-1-2004;ISO 5356-2-2006;ISO 14971-2007;EN 13544-2-2002;IEC 62366-2007
適用范圍：This part of ISO 80369 specifies general requirements for SMALL-BORE CONNECTORS, which convey liquids orgases in healthcare APPLICATIONS. These SMALL-BORE CONNECTORS are used in MEDICAL DEVICES orACCESSORIES intended for use with a PATIENT.This International Standard also specifies the healthcare fields in which these SMALL-BORE CONNECTORS areintended to be used.These healthcare fields of use include, but are not limited to, APPLICATIONS for:- BREATHING SYSTEMS and driving gases,- enteral and gastric,- urethral 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 CONNECTOR and mating ports specified in Annex DD of ISO 8185:2007; and- the nipples of EN 13544-2:2002.This International Standard provides the methodology to assess NON-INTERCONNECTABLE characteristics ofSMALL-BORE CONNECTORS based on their inherent design and dimensions in order to reduce the RISK ofmisconnections between MEDICAL DEVICES or between ACCESSORIES for different APPLICATIONS and to reducethe RISK of misconnections between MEDICAL DEVICES with 6 % Luer CONNECTORS, and all other non-LuerCONNECTORS 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-BORECONNECTORS. Such requirements are given in particular International Standards for specific MEDICAL DEVICESor ACCESSORIES.