Artificial Plasma ISO – Simulated Body Fluid (ISO 23317 Type)

Artificial Plasma ISO – Simulated Body Fluid (ISO 23317 Type)

ISO 23317 compliant artificial plasma / simulated body fluid

Testonic™ Artificial Plasma ISO is a standardized Simulated Body Fluid (SBF) developed to mimic the inorganic ionic composition of human blood plasma in accordance with ISO ISO 23317.

This solution is specifically designed for evaluating the in vitro hydroxyapatite (Ca-P) formation ability of biomaterials and implant surfaces, providing highly reproducible and comparable test results.

Product Description

Testonic™ Artificial Plasma ISO is a protein-free, inorganic biomimetic solution composed exclusively of controlled ionic species. It simulates the ionic environment of human plasma and is widely used to assess the bioactivity and surface behavior of implantable materials.

Prepared in accordance with ISO 23317, this solution ensures batch-to-batch consistency and international comparability, making it suitable for both research and regulatory applications.

Why Artificial Plasma ISO?

This solution enables the simulation of physiological conditions in a controlled laboratory environment.

In SBF ISO conditions:

• Calcium and phosphate ions interact with material surfaces

• Hydroxyapatite-like layers are formed

• These formations indicate the material’s osteointegration potential

Results obtained using ISO-compliant SBF are:

✔ Reproducible
✔ Comparable across laboratories
✔ Suitable for regulatory and validation studies

Applications

1. ISO 23317 Compliant Biomaterial Testing

Evaluation of hydroxyapatite formation on bioactive materials under standardized conditions.

2. Medical Device Validation

Performance testing of dental and orthopedic implants in accordance with international standards.

3. Surface Modification Studies

Comparison of coating and surface treatment methods such as anodization, plasma spraying, and chemical treatments.

4. Research & Development

Preliminary biological performance evaluation of newly developed biomaterials, ceramics, and composites.

5. Quality Control and Standardization

Routine testing to ensure consistent surface bioactivity in manufacturing processes.

Target Users

• Medical device manufacturers

• Dental and orthopedic implant producers

• Biomaterials R&D laboratories

• Academic research institutions

• Regulatory and quality control teams

Technical Specifications

• Standard: ISO 23317 compliant

• Product type: Artificial Plasma / Simulated Body Fluid

• Ionic composition: Na⁺, K⁺, Mg²⁺, Ca²⁺, Cl⁻, HCO₃⁻, HPO₄²⁻, SO₄²⁻

• pH: 7.40 ± 0.02 (at 36.5 °C)

• Buffer system: TRIS / HCl

• CO₂ requirement: None

• Composition: Protein-free, inorganic solution

• Sterility: Non-sterile (can be filtered if required)

Packaging & Storage

• Available in 250 mL, 500 mL, and 1 L packages

• Store at 4 °C in a dark environment

• Bring to 36.5–37 °C before use

Advantages

► Fully compliant with ISO 23317
► High reproducibility and process reliability
► Suitable for international comparative studies
► Controlled ionic composition for consistent performance
► Ideal for both industrial and academic applications

Conclusion

Testonic™ Artificial Plasma ISO provides a reliable, standardized testing environment for evaluating the bioactivity of biomaterials and implant surfaces. It is an essential tool for professionals seeking ISO-compliant, reproducible, and scientifically robust results in biomaterials research and medical device development.