ISO/TS 23128:2019

Medical devices — Transfusion set and blood bag compatibility test method

Standard Details

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 StandardDetails. This document was therefore developed to support the implementation of the existing StandardDetails 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

Status : Published

Standard Type: Main

Document No: ISO/TS 23128:2019

Document Year: 2019

Pages: 9

Edition: 1

Section Volume:
ISO/TC 76. Transfusion, infusion and injection, and blood processing equipment for medical and pharmaceutical use

ICS:
11.040.20 Transfusion, infusion and injection equipment

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ISO/TS 23128:2019

ISO/TS 23128:2019

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