Overview
ISO 19023:2018 is an international standard established by the International Organization for Standardization (ISO) which specifies requirements and test methods for orthodontic anchor screws used in orthodontic treatment. These screws are temporary medical devices inserted into the maxillo-facial bone to provide intraoral skeletal anchorage for orthodontic appliances. Unlike permanent dental implants that require osseointegration, orthodontic anchor screws are intended for temporary use and are removed once orthodontic treatment concludes.
This standard addresses the need for unified criteria to compare physical and mechanical properties of these screws, covers test methods for torsional performance, dimensional accuracy, and defines requirements for packaging and labelling. By adhering to ISO 19023, manufacturers can ensure product consistency while enabling clinicians to make informed decisions based on reliable, comparable data.
Key Topics
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Material Specifications
Orthodontic anchor screws must be manufactured using materials conforming to recognized standards such as ISO 5832-2, ISO 5832-3, ASTM F67, or ASTM F136. Hazardous elements like cadmium, beryllium, lead, and nickel must be declared and controlled due to their potential biological risks.
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Dimensional Requirements
The standard defines critical screw dimensions, including major thread diameter, shaft length, and head height, facilitating consistent sizing and fit across different brands and manufacturers.
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Torsional Performance Testing
- Fracture Torque: Measures the maximum torque the screw can withstand before breaking.
- Insertion Torque: Assesses the torque required during screw insertion into a synthetic bone analogue simulating the highest bone density.
Both tests follow established protocols such as ASTM F543-17 to ensure accuracy and repeatability.
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Packaging and Labelling
Packaging must maintain sterility and protect against contamination where applicable. Labelling requirements include manufacturer details, product name, batch number, quantity, sterility state, and expiration date. Instructions for use must cover intended use, insertion methods, torque specifications, sterilization procedures, and safety warnings.
Applications
ISO 19023:2018 applies primarily to manufacturers, dental laboratories, and orthodontic clinicians who utilize orthodontic anchor screws in:
- Providing temporary skeletal anchorage to improve orthodontic treatment effectiveness
- Assisting in complex tooth movement cases by stabilizing anchorage points intraorally
- Enhancing patient outcomes by ensuring product safety, mechanical reliability, and clinical predictability
- Supporting regulatory compliance and quality assurance processes in dental device manufacturing and distribution
Clinicians benefit from standardized product information, improved screw performance assessment, and safer clinical use through adherence to this standard.
Related Standards
ISO 19023:2018 works in conjunction with several important standards that reinforce its scope and ensure comprehensive safety and effectiveness of orthodontic anchor screws:
- ISO 10993-1 – Biological evaluation of medical devices to assess biocompatibility and toxicological risks
- ISO 7405 – Evaluation of biocompatibility specific to dentistry applications
- ISO 5832-2 and ISO 5832-3 – Specifications for metallic materials, including titanium alloys for surgical implants
- ASTM F543-17 – Standard test methods for metallic medical bone screws, covering torsional performance protocols
- ISO 8601 – Standardized representation of dates and times for labelling accuracy
By integrating ISO 19023 with these standards, manufacturers and clinical users ensure orthodontic anchor screws meet stringent quality, safety, and performance benchmarks.
Keywords: orthodontic anchor screws, ISO 19023, orthodontic treatment, torsional performance, medical device standards, dental implants, screw dimensions, packaging and labelling, biocompatibility, orthodontic anchorage, maxillo-facial bone, screw fracture torque, insertion torque, orthodontic appliances standard, dental device regulations.