ISO 15841:2014/Amd 1:2020

Overview

ISO 15841:2014/Amd 1:2020 is an important international standard that amends the original ISO 15841:2014 concerning wires used in orthodontics. Developed by ISO Technical Committee ISO/TC 106, Dentistry, in cooperation with the European Committee for Standardization (CEN/TC 55), this amendment enhances the specifications and testing protocols for orthodontic wires. The document ensures quality and safety in orthodontic treatments by establishing consistent requirements for materials used in dental wire applications.

Key highlights include:

• Refined definitions for conducting type tests on representative samples.
• Clarified treatment of test results to ensure compliance with manufacturers' specified performance ranges.
• Alignment with international directives and careful attention to intellectual property and patent rights associated with the materials.

This standard is crucial for manufacturers, dental professionals, and regulatory bodies to maintain high-quality orthodontic wire products that meet global health and safety requirements.

Key Topics

• Type Testing Procedures
  The amendment clarifies that all tests outlined in the document are to be considered type tests, conducted on representative samples. This reinforces uniformity in evaluating the mechanical and physical properties of orthodontic wires.

• Treatment of Test Results
  A new subclause (6.5) mandates that test results must fall within the manufacturer's specified ranges-particularly concerning parameters detailed in clauses 7.1 d), e), and f). This ensures that wires not only meet but maintain the required quality benchmarks for orthodontic application.

• Collaboration and Compliance
  The document reflects international cooperation between ISO and CEN under the Vienna Agreement, promoting harmonization in dental material standards across Europe and worldwide.

• Legal and Copyright Considerations
  The standard includes clear guidance on usage rights, reproduction restrictions, and respect for potential patented technologies related to orthodontic wire materials.

Applications

ISO 15841:2014/Amd 1:2020 focuses specifically on orthodontic wires that play a critical role in various dental treatments such as:

• Braces and Wire-based Orthodontic Appliances
  Ensures that the wires used for moving and aligning teeth have the necessary mechanical properties and biocompatibility.

• Custom Orthodontic Material Production
  Enables manufacturers to produce wires consistent with global safety and performance criteria, facilitating international trade and user confidence.

• Quality Assurance in Dental Laboratories
  Helps labs verify that orthodontic wire materials conform to international testing and performance standards before clinical use.

• Regulatory Compliance and Clinical Safety
  Assists regulatory bodies in evaluating orthodontic wire products to protect patient health and uphold high clinical standards.

Related Standards

• ISO/TC 106 Dentistry Standards
  ISO 15841 is part of a larger family of dental material standards, including those related to restorative materials, orthodontic brackets, and other dental devices.

• ISO/IEC Directives
  The development and maintenance of ISO 15841 adhere to these directives, ensuring editorial consistency and proper procedural frameworks.

• CEN/TC 55 Dentistry Standards
  Collaborative standards under CEN complement the ISO requirements, facilitating unified European and international market access for orthodontic products.

• Patent Declarations and Intellectual Property Guidelines
  References to identified patents linked with orthodontic wire technology ensure transparent use and licensing of proprietary innovations.

Keywords: ISO 15841:2014 Amendment 1, orthodontic wires, dentistry standards, orthodontic wire testing, ISO dental standards, orthodontic appliance materials, dental wire quality, international dental standards, orthodontic wire compliance, dental material type testing.