Product Specifications Overview

The document provides approximate product specifications related to injection moulding materials used by ModenPlast Medical. These specifications are subject to change, and further information can be obtained by contacting the company directly.

Material Properties and Certifications

• Hardness: The materials have a Shore A hardness ranging from 81 to 92.
• Certification: Compliance with the European Pharmacopoeia is confirmed for the materials.
• Biocompatibility: The materials meet ISO 10993 standards, specifically ISO 10993:2018, ensuring suitability for medical applications.
• Phthalates Content: Some materials contain phthalates, while others are phthalate-free.
• Stabilization: Calcium/Zinc (Ca/Zn) stabilization is used in the materials.

Summary of Variants

Three variants of the injection moulding materials are described, all sharing the same hardness range and certifications but differing in phthalate content:

1. Material with phthalates present, Ca/Zn stabilized.
2. Phthalate-free material, Ca/Zn stabilized.
3. Another phthalate-free material, Ca/Zn stabilized.

Key Points and Recommendations

• The hardness range (Shore A 81-92) indicates materials suitable for flexible yet durable medical components.
• Compliance with EU Pharmacopoeia and ISO 10993:2018 ensures regulatory acceptance and biocompatibility for medical use.
• Phthalate-free options are available, addressing concerns related to plasticizer safety.
• Ca/Zn stabilization suggests environmentally friendlier stabilizers compared to heavy metal alternatives.
• Users should verify the specific material variant and certification status before application.