International Standard
ISO/TS 23128:2019
Medical devices — Transfusion set and blood bag compatibility test method
Reference number
ISO/TS 23128:2019
Edition 1
2019-12
International Standard
Read sample
ISO/TS 23128:2019
78329
Published (Edition 1, 2019)
This standard was last reviewed and confirmed in 2023. Therefore this version remains current.

ISO/TS 23128:2019

ISO/TS 23128:2019
78329
Language
Format
CHF 63
Convert Swiss francs (CHF) to your currency

Abstract

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

  •  : Published
     : 2019-12
    : International Standard confirmed [90.93]
  •  : 1
     : 9
  • ISO/TC 76
    11.040.20 
  • RSS updates

Sustainable Development Goals

This standard contributes to the following Sustainable Development Goal

Got a question?

Check out our FAQs

Customer care
+41 22 749 08 88

Opening hours:
Monday to Friday - 09:00-12:00, 14:00-17:00 (UTC+1)