ISO 17254:2016/Amd 1:2020

Overview

ISO 17254:2016/Amd 1:2020 is an important amendment to the international standard governing coiled springs used in orthodontics. Established by the International Organization for Standardization (ISO), this update refines testing methods and compliance criteria to ensure the quality and mechanical performance of orthodontic springs. These springs play a critical role in the controlled application of force to teeth, facilitating effective orthodontic treatments.

Key Topics

• Testing and Type Tests
  The amendment clarifies that all tests specified in the document are type tests, which must be conducted on representative samples of the orthodontic coiled springs. This ensures that the testing results accurately reflect the product's overall quality and performance.

• Mechanical Behavior Evaluation
  The revised procedures focus on evaluating the springs’ mechanical behavior, particularly during the unloading phase of force-displacement tests. This detailed assessment ensures springs deliver consistent and predictable force during orthodontic applications.

• Compliance and Manufacturer’s Specifications
  To meet the standard, the test results for each spring specimen must fall within the range specified by the manufacturer, as detailed in clauses 6.1 b) and 6.1 d). This requirement guarantees products align with stated mechanical characteristics, improving reliability and safety in clinical use.

• Collaborative Development
  This standard was developed by ISO Technical Committee ISO/TC 106 (Dentistry), Subcommittee SC 1 (Filling and Restorative Materials), in collaboration with the European Committee for Standardization (CEN), under the Vienna Agreement. This joint effort highlights global cooperation to unify dental material standards.

Applications

• Orthodontic Treatment
  Coiled springs complying with ISO 17254:2016/Amd 1:2020 are used to apply precise forces to teeth, aiding in alignment and correction treatments. Ensuring springs meet these rigorous standards supports optimal force delivery and improves patient outcomes.

• Dental Manufacturing
  Manufacturers of orthodontic appliances benefit from this standard by following clearly defined test procedures to produce consistent and high-quality springs. It aids in product development, quality assurance, and regulatory compliance.

• Quality Control and Testing
  Dental laboratories and testing facilities utilize ISO 17254 to verify the mechanical properties of orthodontic springs before clinical deployment. This testing framework helps prevent the use of substandard components in orthodontic devices.

Related Standards

• ISO/TC 106 Series (Dentistry Standards)
  This series covers a broad range of dental materials and devices, including restorative materials, dental implants, and orthodontic appliances, ensuring comprehensive quality management in dental care.

• ISO/IEC Directives, Part 1 and Part 2
  These directives guide the development, approval, and maintenance of ISO standards, including editorial rules and document structures related to this amendment.

• European Committee for Standardization (CEN) Standards on Dentistry
  Collaboration under the Vienna Agreement aligns ISO 17254 with European dental materials standards, facilitating international harmonization and acceptance.

Keywords: ISO 17254:2016, orthodontic coiled springs, dentistry standards, orthodontic spring testing, mechanical behavior, force-displacement test, orthodontic appliance quality, dental materials standards, ISO dental amendments, international dental standards.