卫生保健应用油库输送系统连接器 - 第3部分:肠内应用

[中文适用范围]： 本文件规定了用于肠营养贮液器的连接器的设计和功能性能的尺寸和要求。本文件不适用于使用这些连接器的医疗器械或附件的尺寸和要求。这种要求由特定的国际标准给出。鼓励制造商将本文件中规定的连接器纳入肠营养医疗设备或附件，即使目前特定医疗器械标准中没有要求。预计当特定医疗器械标准修订时，将包含根据ISO 18250规定的贮液器连接器的要求。本文件不适用于螺纹盖和皇冠瓶帽和颈部，因为它们不是特定于医疗器械的连接器。它们更属于食品和饮料包装领域，尽管经常需要肠营养给药装置与它们连接。 [外文原描述]： This document specifies dimensions and requirements for the design and functional performance of connectors intended to be used on enteral reservoirs. This document does not specify the dimensions and requirements for the medical devices or accessories that use these connectors. Such requirements are given in particular International Standards for specific medical devices or accessories. NOTE 1 Manufacturers are encouraged to incorporate the connectors specified in this document into enteral medical devices or accessories, even if not currently required by the particular medical device Standards. It is expected that when the particular medical device Standards are revised, requirements for reservoir connectors, as specified in ISO 18250, will be included. This document does not apply to screw and crown cork caps and necks as they are not connectors specific for medical devices. They rather belong to the food and beverage packaging domain despite often enteral giving sets are required to connect with them. NOTE 2 Examples of screw caps and necks are defined in DIN 55525:1988, ASTM D2911-94 (reapproved 2001), DIN 6063-1:2004, DIN 6063-2:2004, DIN 168-1:1998. Examples of crown cork caps and necks are defined in DIN 6094-1:1998, ISO 12821:2013, EN 14635:2010.