RS ISO/TS 23128: 2019
Medical devices — Transfusion set and blood bag compatibility test method


This document details suitable equipment, a test method, acceptance criteria and advisable limits to help
to ensure that there is compatibility (by measuring the insertion force) between a transfusion set closure
piercing device (referred to in this document by the abbreviation spike) and a blood bag outlet port.
The test procedure in its entirety is complex and beyond the scope of each of the relevant transfusion
set and blood bag standards. This document was therefore developed to support the implementation of
the existing standards for blood bags and transfusion sets.
The procedure described in this document can be used by manufacturers of blood bags to test the
compatibility with transfusion set spikes available on the market or by manufacturers of the transfusion
set spikes to test the compatibility with blood bags available on the market.

General Information

RS ISO/TS 23128: 2019ADOPTED ISO STANDARDSPackaging and distribution of goods17First Edition
Oct 2022
Price: RWF 13,500

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