标准编号：ISO/TS 23128:2019
中文名称：医疗器械 输血装置和血袋相容性试验方法
英文名称：Medical devices — Transfusion set and blood bag compatibility test method
发布日期：2019-12
标准范围
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.
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