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 transfusion 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 that the force required to insert the spike into the port is not excessive. The spike is a rigid structure with tightly defined dimensions whereas the blood bag port is of flexible material to accommodate the spike.
ISO/TS 23128 guideline assists you with materials, equipment, labeling, and preparation for insertion force equipment, transfusion sets, blood bags, and test worksheet to test compatibility in transfusion sets and blood bags.
The procedure given in ISO/TS 23128 is useful for testing the compatibility with transfusion set spikes to prevent damage to the blood bag, leakage of its contents, and injuries to bedside staff.
