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DS/ISO/TS 23128:2019现行

Medical devices – Transfusion set and blood bag compatibility test method

出版:Danish Standards

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基本信息
标准编号: DS/ISO/TS 23128:2019
标准类别:Test Method
出版单位:Danish Standards
标准页数:0
标准简介

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.

标准备注

本标准等同于ISO/TS 23128:2019

等同采用的国际标准

ISO/TS 23128:2019 - Identical