BS EN ISO 20795-1:2013

Comprehensive Standard for Dental Base Polymers

BS EN ISO 20795-1:2013 is the essential standard for dental base polymers, providing comprehensive guidelines and requirements for the materials, testing, and performance of dental prostheses. This standard, identical to ISO 20795-1:2013, is a crucial reference for dental professionals, manufacturers, and regulators, ensuring the quality, safety, and compliance of dental base polymer products.

Ensuring Quality and Safety in Dental Prosthetics

The BS EN ISO 20795-1:2013 standard covers a wide range of technical specifications and requirements for dental base polymers, including:

• Material Composition: Detailed guidelines on the composition and properties of dental base polymers, ensuring consistent quality and performance.
• Testing Procedures: Comprehensive testing methods for evaluating the physical, chemical, and mechanical properties of dental base polymers, including flexural strength, impact resistance, and water absorption.
• Biocompatibility: Requirements for the biocompatibility of dental base polymers, ensuring the safety and well-being of patients.
• Labeling and Packaging: Standards for the labeling and packaging of dental base polymer products, promoting transparency and traceability.

Compliance and Regulatory Alignment

By adhering to the BS EN ISO 20795-1:2013 standard, dental professionals and manufacturers can ensure that their products meet the highest quality and safety standards. This standard is aligned with the latest regulatory requirements, including:

• European Union: The standard is harmonized with the essential requirements of the Medical Devices Directive (93/42/EEC), ensuring compliance with EU regulations.
• International: The standard is identical to ISO 20795-1:2013, promoting global harmonization and facilitating international trade in dental base polymer products.

Key Benefits of Adhering to BS EN ISO 20795-1:2013

By implementing the guidelines and requirements outlined in BS EN ISO 20795-1:2013, dental professionals and manufacturers can enjoy the following benefits:

• Improved Patient Safety: The standard's focus on biocompatibility and material safety helps ensure the well-being of patients who use dental prostheses.
• Enhanced Product Quality: Comprehensive testing and material specifications help maintain consistent quality and performance of dental base polymer products.
• Regulatory Compliance: Alignment with the latest EU and international regulations simplifies the approval and marketing of dental base polymer products.
• Competitive Advantage: Adherence to this industry-leading standard can differentiate products and build trust with customers and regulatory authorities.

Whether you are a dental professional, a manufacturer, or a regulator, BS EN ISO 20795-1:2013 is an essential reference for ensuring the quality, safety, and compliance of dental base polymer products. By adopting this standard, you can contribute to the advancement of dental prosthetics and the well-being of patients worldwide.