Medical-Grade Plasticizers: Requirements & Standards

• 27.11.2025

Plasticizers used in medical-grade PVC applications must meet the highest standards of biocompatibility, purity and safety. The choice of plasticizer directly affects patient health, regulatory compliance and product performance.

1. Core Requirements of Medical-Grade Plasticizers

1) Biocompatibility

Must not cause toxicity, irritation or allergic reactions.

• Compliance with ISO 10993 is essential.

2) Low Migration

Used safely in applications involving blood, IV solutions or respiratory contact.

3) Thermal Stability

Must tolerate ETO, steam and gamma sterilization without degradation.

4) Optical & Mechanical Properties

Should maintain PVC clarity and flexibility.

2. Types of Medical-Grade Plasticizers

• TOTM (Trioctyl Trimellitate)

• Extremely low migration

• Excellent sterilization resistance

• Ideal for blood bags & tubing

• DINCH

• Safe, non-phthalate alternative

• Widely adopted across Europe

• Citrate Esters (ATBC, TEC)

• High clarity

• Suitable for food-contact and medical use

• Polymeric Plasticizers

• Ultra low extraction

• Designed for long-term applications

3. Application Fields

• IV sets

• Catheters

• Blood bags

• Oxygen masks

• Respiratory tubes

Conclusion

The medical industry is moving steadily toward safe, non-phthalate plasticizers. Choosing the right medical-grade plasticizer ensures compliance, durability and patient safety.