SIST EN ISO 27020:2019 PDF

Overview

EN ISO 27020:2019 - Dentistry: Brackets and tubes for use in orthodontics (ISO 27020:2019) specifies requirements and test methods to enable meaningful comparison of orthodontic brackets and tubes used in fixed orthodontic appliances. The standard covers functional dimensions, angular geometry, chemical ion release (corrosion/ion release testing), and required packaging and labelling information. It is a CEN-endorsed European adoption of ISO 27020:2019 and supersedes earlier editions.

Key topics and technical requirements

• Dimensional and geometric requirements
  • Definitions and measurement procedures for critical features such as slot height, slot depth, slot length, in‑out, angulation, angle of torque, and rotational offset to ensure interchangeability and predictable clinical performance.
  • Standardized apparatus and measurement procedures for accurate, repeatable dimension assessment.
• Chemical release and corrosion
  • Test methods to evaluate chemical ion release from metallic brackets and tubes, including a static immersion corrosion test added in the 2019 edition.
  • Identification of hazardous elements (cadmium, beryllium, lead, nickel) whose concentrations manufacturers must declare as mass fractions (%).
• Packaging and labelling
  • Requirements for information that must be supplied to the user, including packaging integrity, traceability and essential product labelling.
• Normative references
  • Uses terminology and definitions from ISO 1942 and refers to corrosion test methods in ISO 10271.

Practical applications and who uses it

• Manufacturers and suppliers of orthodontic brackets and tubes use EN ISO 27020:2019 to design, validate and declare product dimensions and corrosion behaviour for regulatory compliance and product specifications.
• Orthodontists and dental clinicians rely on standardized dimensional and labelling information to select compatible brackets/tubes and archwires, improving clinical predictability.
• Laboratories and test houses perform the standardized measurement and corrosion tests to generate comparative data and supporting documentation.
• Regulatory bodies and procurement teams use the standard as a benchmark for product evaluation, tendering and conformity assessment.

Related standards

• ISO 10993‑1 and ISO 7405 - biological evaluation of medical/dental devices (biocompatibility) - EN ISO 27020:2019 does not replace these requirements.
• ISO 1942 - dentistry vocabulary.
• ISO 10271 - corrosion test methods for metallic dental materials.

EN ISO 27020:2019 helps ensure consistent, comparable information on orthodontic brackets and tubes - improving product interoperability, safety declarations (hazardous elements), and clinical decision-making.