PD ISO/TS 23128:2019 PDF

What is ISO/TS 23128 - Transfusion set and blood bag compatibility test method about?

ISO/TS 23128 discusses medical devices. ISO/TS 23128 is an international standard that provides t ransfusion sets and blood bag compatibility test methods in medical devices. ISO/TS 23128 outlines 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 ISO/TS 23128 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. ISO/TS 23128 was therefore developed to support the implementation of the existing standards for blood bags and transfusion sets.

Who is ISO/TS 23128 - Transfusion set and blood bag compatibility test method for?

ISO/TS 23128 on transfusion set and blood bag compatibility test methods for medical devices is useful for:

Manufacturers of medical devices Test centers for medical devices Regulatory authorities

Why should you use ISO/TS 23128 - Transfusion set and blood bag compatibility test method ?

Transfusion sets are compatible with a range of commercially available blood bags and vice versa. It is vitally important in setting up a blood transfusion tha...