标准2025通过静脉输送药物或其他维持生命的药剂可以挽救生命。但混用注射接头则意味着注入错误药剂，从而导致灾难性后果。静脉注射或皮下注射应用的连接器的新标准刚刚出版，补充了专门用于降低这种医疗环境中的风险的一系列标准。
ISO 80369-7:2016 用于注射液体与气体医疗应用的小孔连接器—第7部分：用于血管内或皮下注射的连接器——此标准规范了小孔连接器的规格、设计需求及功能特性需求，它适用于医疗设备与配件的血管内和皮下应用。联合工作小组ISO/TC 210/JWG 4的召集人斯科特.科尔伯恩说道：“过去，许多输送设备——比如用于静脉输送的设备——使用的是一套通用的连接器。但是当一个病人身上有许多不同的输送管时，两个独立临床应用之间的误接风险就会很高，这必然是十分可怕的。如今，医疗设备的设计可针对每种输送类型采用特定的连接器。此系列新标准可通过定义各临床应用的不同连接器来帮助减少误接风险，从而减少由于疏忽而错误连接的风险。”
本标准与ISO 80369系列中的其他标准一起取代了以前的两项ISO标准（ISO 594 6%（鲁尔标准）锥度的锥形连接配件，适用于注射器、针头及某些其他医疗设备—部件1与部件2）。该标准描述了更易交替使用的连接器，医疗工作者稍有疏忽就会误接。对比ISO 594标准，ISO 80369标准的重要改变包括能够更好地定义连接器类型的新的条件条款，新标准概括了连接器的要求，而不是这些连接器配件的要求。
ISO 80369系列中的其他标准有：
- ISO 80369-1 通用要求；
- ISO 80369-2 : 呼吸系统及驱动气体应用连接器*
- ISO 80369-3,肠内应用连接器；
- IEC 80369-5 肢体袖带充气应用连接器；
- ISO 80369-6 神经轴应用连接器；及
- ISO 80369-20 常用测验方法
ISO 80369-7标准，可到ISO国家成员或ISO商店购买。
ISO 80369-1 通用要求；
Reducing risk in intravenous delivery is the aim of new standard
Intravenous delivery of medication or other vital products can save lives. But mix-ups with connectors that mean the wrong product is delivered can have catastrophic consequences. A new standard for connectors with intravenous or hypodermic applications has just been published, complementing the series of standards dedicated to reducing risks in such medical settings.
ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications — Part 7: Connectors for intravascular or hypodermic applications – specifies dimensions and requirements for the design and functional performance of small bore connectors for use in intravascular or hypodermic applications of medical devices and accessories.
Scott Colburn, Convenor of the joint working group ISO/TC 210/JWG 4 said: ‘In the past, many delivery devices such as those for intravenous delivery used a universal system of connectors. But when a patient had several different tubes around them, there was an elevated risk of misconnections between two separate clinical applications, which, of course, could be disastrous. Now there are specific connectors for each type of delivery that medical devices can incorporate into their design. This new series of standards helps to reduce the risk of misconnection by defining the different connectors within each clinical application, thus reducing the risk of being connected inadvertently to the wrong application.”
This standard together with the others in the ISO 80369 series replaces two previous ISO standards (ISO 594 Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment – Parts 1 and 2), that described more interchangeable connectors which could inadvertently result in misconnections by health care workers. Key changes between the ISO 594 standards and ISO 80369 include new terms of conditions, to better define the types of connectors and a change whereby the new standard outlines the requirements for connectors rather than the requirements for the fitting of these connectors.
Other standards in the ISO 80369 series include:
- ISO 80369-1 General requirements;
- ISO 80369-2 : Connectors for breathing systems and driving gases applications*
- ISO 80369-3, Connectors for enteral applications;
- IEC 80369-5 Connectors for limb cuff inflation applications;
- ISO 80369-6 Connectors for neuraxial applications; and
- ISO 80369-20 Common test methods
ISO 80369-7 can be purchased from your national ISO member or the ISO Store.
- ISO 80369-1 General requirements;