What is ISO 15823:2018?

ISO 15823:2018 is a technical standard that establishes guidelines and requirements for the evaluation of the performance of dental CAD/CAM (Computer-Aided Design/Computer-Aided Manufacturing) systems. These systems are widely used in the dental industry for the fabrication of dental prosthesis such as crowns, bridges, and implants.

The Purpose of ISO 15823:2018

The purpose of ISO 15823:2018 is to provide a framework for the assessment and certification of dental CAD/CAM systems. The standard defines the criteria for evaluating the accuracy, reliability, and safety of these systems, ensuring that they meet the necessary quality standards required for their use in dentistry.

Key Requirements of ISO 15823:2018

ISO 15823:2018 outlines specific requirements that dental CAD/CAM systems must adhere to in order to be considered compliant with the standard. These requirements include:

Dimensional Accuracy: The system should be capable of producing dental restorations that accurately match the specifications provided by the dentist.

Material Compatibility: The system should be compatible with a wide range of dental materials commonly used in prosthetic procedures, such as ceramics, metals, and polymers.

Process Reliability: The system should be reliable and produce consistent results over multiple manufacturing cycles.

User Safety: The system should have built-in safety measures to ensure the protection of both patients and operators.

Data Security: The system should have proper data management practices in place to protect patient information and maintain confidentiality.

The Benefits of ISO 15823:2018 Compliance

Compliance with ISO 15823:2018 offers several benefits to dental CAD/CAM system manufacturers, dental laboratories, and ultimately, patients:

Quality Assurance: Compliance ensures that dental CAD/CAM systems meet the necessary quality standards, providing assurance to users that they can rely on these systems for accurate and reliable dental restorations.

Interoperability: Compliance facilitates interoperability between different dental CAD/CAM systems, allowing for seamless collaboration between dental professionals and laboratories.

Patient Safety: Compliance with ISO 15823:2018 helps safeguard patient safety by ensuring that the dental restorations produced by these systems are both safe and effective.

Market Access: Compliance with global standards like ISO 15823:2018 enables manufacturers to access international markets, increasing their reach and potential customer base.

In conclusion, ISO 15823:2018 plays a crucial role in ensuring the performance, reliability, and safety of dental CAD/CAM systems. Compliance with this standard provides confidence to both manufacturers and end-users, ultimately benefiting the entire dental industry and the patients it serves.