Overview
ISO/TS 23128:2019 - Medical devices - Transfusion set and blood bag compatibility test method - defines a standardized test method to evaluate mechanical compatibility between a transfusion set spike (closure-piercing device) and a blood bag outlet port. The Technical Specification describes suitable equipment, test setup, stepwise procedure, recording format and guidance on interpreting spike insertion force measurements to help ensure safe, reliable connections during blood transfusion.
Key Topics and Requirements
- Objective: Measure the minimum insertion force required for a spike to fully penetrate a blood bag port septum and determine compatibility.
- Test samples: Three separate spike/port combinations (from transfusion sets and blood bags conforming to ISO 1135-x and ISO 3826-x).
- Environmental control: Test and storage at (23 ± 2) °C for at least 12 hours before testing.
- Test equipment: A calibrated insertion force apparatus (shaft/chuck assembly and standard masses); base mass of shaft + chuck + nuts = 2 000 g → base force 20 N. Additional masses of 0,25 kg are added incrementally following the standard.
- Procedure highlights:
- Isolate spikes and prepare fluid-filled blood bag ports (water or anticoagulant solution acceptable).
- Introduce spike into port under controlled loading and twist the spike 5 times through 180° to confirm penetration.
- Increase loading in 0,25 kg steps until septum penetration occurs; record minimum insertion force.
- Optional simplified check: single test at 50 N if quantitative data not required.
- Reporting: Use worksheet/report format (Annex B) capturing sample IDs, environmental checks, measured insertion forces (minimum, mean, maximum) and test conclusion.
- Interpretation: Typical compatibility range cited is 20 N to 50 N.
Applications and Who Uses It
- Blood bag manufacturers - validate that bag ports accommodate market spikes safely.
- Transfusion set (spike) manufacturers - verify spike designs are compatible with common blood bag ports.
- Medical device test laboratories and QA teams - perform incoming inspection, design verification, bench testing and supplier qualification.
- Regulatory and clinical risk assessors - incorporate test evidence into conformity assessment, risk management and labeling guidance.
- Practical benefits include reduced risk of bag damage, leakage, needle-stick-type injuries during bedside setup, and improved interoperability in transfusion workflows.
Related Standards
Keywords: ISO/TS 23128:2019, transfusion set spike, blood bag compatibility, insertion force test, medical devices standard, spike insertion force.