BS EN ISO 19023:2018

Overview

BS EN ISO 19023:2018 is a vital standard within the realm of health care technology, specifically addressing orthodontic anchor screws used in dentistry. This standard provides comprehensive guidelines for the design, testing, and application of orthodontic anchor screws, ensuring their safety and efficacy in clinical use. The standard is aligned with ISO 19023:2018, ensuring global consistency in orthodontic practices.

Key Requirements

The standard outlines several key requirements that manufacturers and dental professionals must adhere to, including:

• Design Specifications: Detailed criteria for the design of orthodontic anchor screws, including dimensions and materials used.
• Performance Testing: Rigorous testing protocols to assess the mechanical properties and biocompatibility of the screws.
• Quality Assurance: Guidelines for quality management systems to ensure consistent manufacturing processes.
• Documentation: Requirements for comprehensive documentation to support compliance and traceability.

Implementation Benefits

Adopting BS EN ISO 19023:2018 offers several practical benefits for dental practitioners and manufacturers:

• Enhanced Patient Safety: By adhering to the standard, practitioners can ensure that the orthodontic anchor screws used are safe and effective, reducing the risk of complications.
• Improved Clinical Outcomes: The standard promotes the use of high-quality materials and designs, which can lead to better treatment results for patients.
• Market Competitiveness: Compliance with this standard can enhance a manufacturer's reputation and marketability, as it demonstrates a commitment to quality and safety.
• Streamlined Processes: Implementing the guidelines can lead to more efficient manufacturing and clinical practices, saving time and resources.

Compliance Value

Compliance with BS EN ISO 19023:2018 is not merely a regulatory requirement; it is an essential aspect of maintaining high standards in dental practice. The standard facilitates:

• Regulatory Compliance: Meeting the requirements of health authorities and regulatory bodies, which is crucial for market access.
• Risk Management: Identifying and mitigating potential risks associated with orthodontic treatments, thereby enhancing patient trust.
• Continuous Improvement: Encouraging ongoing evaluation and enhancement of practices based on the latest scientific evidence and technological advancements.

In conclusion, BS EN ISO 19023:2018 serves as a foundational standard for orthodontic anchor screws, promoting safety, efficacy, and quality in dental practices. Compliance not only benefits manufacturers and practitioners but ultimately enhances patient care in orthodontics.