Physical Address
304 North Cardinal St.
Dorchester Center, MA 02124
A Technical Review of ISO 8638-12:2017: Blood Tubing Sets for Haemodialysis and Related Therapies
Ensuring safety and performance in extracorporeal blood circuits through international standardization.
1. Scope and Purpose
ISO 8638-12:2017 specifies requirements for blood tubing sets intended for use in haemodialysis, haemodiafiltration and haemofiltration. These single-use sets form the extracorporeal blood circuit connecting the patient’s vascular access to the dialyzer or haemofilter. The standard covers arterial and venous lines, drip chambers, injection ports, pressure monitoring lines, and any integral components.
The standard aims to ensure patient safety by defining minimum mechanical, biocompatibility, and performance criteria. It also provides test methods for evaluating these properties.
2. Technical Requirements
Blood tubing sets must comply with a range of technical specifications, including:
- Materials: All materials in contact with blood or infusion fluids must be biocompatible (ISO 10993 series) and must not leach harmful substances beyond established limits. Additives such as plasticizers are restricted.
- Dimensions and connectors: Tubing internal diameters and lengths are specified to achieve adequate flow rates. Connectors must conform to ISO 594 (Luer connectors) or equivalent national standards to ensure compatibility.
- Mechanical strength: The assembly must withstand internal pressures without leakage or rupture. Typical burst pressure requirements are ≥ 1000 mmHg.
- Flow performance: Maximum flow rate versus pressure drop curves are defined. Priming volume must be minimized.
- Biocompatibility: Cytotoxicity, sensitization, irritation, acute systemic toxicity must be tested per ISO 10993.
- Sterility: Sets must be supplied sterile (SAL 10−6) with appropriate packaging integrity.
- Extractables: Total organic carbon (TOC)