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现行 CAN/CSA Z5359:16(R2020)
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Anaesthetic and respiratory equipment - Low-pressure hose assemblies for use with medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems (Adopted ISO 5359:2014, fourth edition, 2014-10-01, with Canadian deviations), Includes Errata (2022) 麻醉和呼吸设备.医用气体 医用真空 医用辅助气体和麻醉气体清除系统用低压软管组件(采用ISO 5359:2014 第四版 2014-10-01 加拿大偏差)
发布日期: 2016-03-01
前言:前言这是CAN/CSA-Z5359《麻醉和呼吸设备——用于医用气体、医用真空、医用辅助气体和麻醉气体清除系统的低压软管组件》的第三版,采用加拿大版本,ISO(国际标准化组织)标准5359(第四版,2014-10-01)标题为麻醉和呼吸设备-医用气体用低压软管组件。 它取代了2010年发布的前一版本,即CAN/CSA-Z5359,医用气体用低压软管组件(采用ISO 5359:2008)。为简洁起见,本标准通篇称为“CAN/CSA-Z5359”。在第三版中,对标题进行了修改,以反映该标准在加拿大的应用。在加拿大,低压软管组件被加拿大卫生部归类为II类医疗设备。范围:1.1本国际标准规定了低成本产品的要求- 用于以下医用气体的压力软管总成:氧气一氧化二氮医用空气HeliumCarbon Dioxide氙气上述气体的特定混合物用于驱动手术工具的富氧空气用于驱动手术工具的氮气用于真空。1.2适用于压力高达1400 kPa的软管总成,以及绝对压力不超过60 kPa的真空系统。1.3本国际标准未规定气体的尺寸和分配- 软管组件的特定入口和出口接头。注1:CGA V-5[28]规定了直径指数安全系统(DISS)连接器的尺寸和配置规范。注2:AS 2896[23]中规定了套管索引系统(SIS)连接器的尺寸和配置规范。注3:ISO 18082[11]规定了非可互换螺纹(NIST)连接器的尺寸和配置。注4:ISO 9170中规定了为快速连接器设计的端子单元- 1.1.4本国际标准未规定用于供应和排出用于驱动手术工具的空气的同轴软管的要求。1.5本国际标准未规定软管组件的预期用途。注:附件B中涉及环境因素。
Preface:Preface This is the third edition of CAN/CSA-Z5359,Anaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases, medical vacuum, medical support gases, and anaesthetic gas scavenging systems, which is an adoption, with Canadian deviations, of ISO (International Organization for Standardization) Standard 5359 (fourth edition, 2014-10-01) titledAnaesthetic and respiratory equipment — Low-pressure hose assemblies for use with medical gases.It supersedes the previous edition, published in 2010 as CAN/CSA-Z5359,Low-pressure hose assemblies for use with medical gases(adopted ISO 5359:2008).For brevity, this Standard will be referred to as "CAN/CSA-Z5359" throughout.In this third edition, the title has been modified to reflect the application of the Standard in Canada.In Canada, low-pressure hose assemblies are classified by Health Canada as Class II Medical Devices.Scope:1.1This International Standard specifies requirements for low-pressure hose assemblies intended for use with the following medical gases:oxygennitrous oxidemedical airheliumcarbon dioxidexenonspecified mixtures of the gases listed aboveoxygen-enriched airair for driving surgical toolsnitrogen for driving surgical toolsand for use with vacuum.1.2It applies to hose assemblies operating at pressures up to 1 400 kPa and for vacuum systems at pressures not greater than 60 kPa absolute.1.3This International Standard does not specify the dimensions and allocation of the gas-specific inlet and outlet connectors for the hose assemblies.Note 1 Specifications for the dimensions and allocation of diameter index safety system (DISS) connectors are specified in CGA V-5 [28].Note 2 Specifications for the dimensions and allocation of sleeve indexed system (SIS) connectors are specified in AS 2896 [23].Note 3 Dimensions and allocation of non-interchangeable screw-threaded (NIST) connectors are specified in ISO 18082 [11].Note 4 Terminal units designed for quick connectors are specified in ISO 9170-1.1.4This International Standard does not specify requirements for coaxial hoses used for the supply and removal of air for driving surgical tools.1.5This International Standard does not specify the intended uses of hose assemblies.Note: Environmental aspects are dealt with in Annex B.
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