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.
Текущий статус : PublishedДата публикации : 2018-06
Версия : 1
Технический комитет:Quality management and corresponding general aspects for medical devices
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