ISO 27020:2019

Overview

ISO 27020:2019 - Dentistry - Brackets and tubes for use in orthodontics is an international standard that defines requirements and test methods for fixed orthodontic brackets and tubes. It standardizes how to report functional dimensions, angular values, chemical ion release from metallic components, and required packaging and labelling information. The document helps clinicians, manufacturers and testing laboratories make meaningful comparisons between products and supports consistent product information for procurement and regulatory review.

Key Topics and Requirements

• Scope: Applies to brackets and tubes used in fixed orthodontic appliances; does not replace biological safety standards (see Related Standards).
• Dimensions & angles: Specifies measurement and reporting of key geometric parameters to the nearest 0.01 mm (dimensions) and 1° (angles), including:
  • in‑out distance
  • slot depth, slot height, slot length
  • auxiliary slot dimensions
  • angle of torque, angulation, and rotational offset
• Measurement methods: Type tests on representative samples using callipers, micrometers, optical comparators or equivalent with an accuracy of 0.005 mm or 0.5°; detailed procedures for constructing reference planes and measuring angles and distances are defined.
• Chemical ion release (corrosion testing): Introduces a static immersion corrosion test (added in this edition) and records release from metallic brackets as μg/20 brackets/7 days and from metallic tubes as μg/8 tubes/7 days (reported to the nearest 10 μg). Total and per-element releases are to be recorded.
• Hazardous elements: Manufacturers must state mass-fraction concentrations for cadmium, beryllium, lead and nickel.
• Packaging & labelling: Defines general packaging and labelling information that must be supplied to users.
• Type tests: All tests are type tests to verify representative product batches.

Practical Applications & Users

ISO 27020:2019 is useful for:

• Orthodontic manufacturers and designers - to verify dimensional conformity and corrosion performance and to prepare compliant technical documentation and labels.
• Dental test laboratories - to perform standardized dimensional and corrosion tests and produce comparable test reports.
• Clinicians and purchasing managers - to compare product specifications objectively when selecting brackets and tubes.
• Regulatory and conformity assessment bodies - for evaluation of device information and performance claims.

Keywords: ISO 27020:2019, orthodontic brackets, orthodontic tubes, bracket dimensions, ion release testing, static immersion corrosion, dental standards.

Related Standards

• ISO 10993‑1 and ISO 7405 - biological hazards / biocompatibility (not covered by ISO 27020)
• ISO 10271:2011 - corrosion test methods for metallic dental materials (referenced)
• ISO 1942 - dentistry vocabulary (terms and definitions used)