This document specifies dimensions and requirements for the design and functional performance of apheresis anticoagulant (AC) reservoir connectors.
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.
The following examples of medical devices are intended to use the connectors of this document:
— Apheresis tubing sets and mating reservoirs containing citrate-based anticoagulant solution.
— Apheresis tubing sets may include, but are not limited to those for use in blood collection, therapeutic applications, and plasma collection.
Some apheresis sets are manufactured with a pre-connected reservoir containing citrate-based anticoagulant solution. These medical devices are not intended to use the connectors of this document.
NOTE Manufacturers are encouraged to incorporate the connectors specified in this document into apheresis 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 apheresis AC reservoir connectors, will be included.
Status: PublishedPublication date: 2018-08
Edition: 1Number of pages: 24
Technical Committee: ISO/TC 210 Quality management and corresponding general aspects for medical devices
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|std 1 124|
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