Overview
EN ISO 17254:2016/A1:2021 is the CEN-adopted amendment to ISO 17254:2016 covering coiled springs for use in orthodontics. Approved by CEN on 12 December 2020 and published in the EN form in April 2021 (Slovenian adoption 01 Jul 2021), this amendment clarifies testing and conformity requirements for orthodontic coiled springs used as dental materials (ICS 11.060.10). It was prepared by ISO/TC 106 in collaboration with CEN/TC 55.
Key topics and technical requirements
- Scope: Applies to coiled springs intended for orthodontic use and their type testing as dental materials.
- Type tests: Clause 5.1 was updated to state explicitly that all tests in the document are type tests, and these shall be performed on representative samples of the item being tested.
- Force–displacement testing: Clause 5.3.2.4 now instructs testers to determine the mechanical behaviour of springs during unloading of the force–displacement test (i.e., behaviour when force is reduced after loading).
- Conformity criteria: Clause 5.4 clarifies that test results for each specimen must lie within the manufacturer’s specified range (referenced in clauses 6.1 b) and 6.1 d)) for the material to comply with the standard.
- Normative status: The amendment was endorsed by CEN without modification and exists in English, French and German official versions. Note: the document flags possible patent rights associated with elements of the standard.
Applications and who uses this standard
This standard is directly relevant to:
- Manufacturers of orthodontic coiled springs - for product design validation, quality control and production acceptance testing.
- Dental product testing laboratories - to perform type tests and produce test reports consistent with ISO/CEN requirements.
- Orthodontists and procurement specialists - to specify compliant springs and understand performance claims.
- Regulatory and quality managers in dental device companies - to demonstrate conformity and prepare technical documentation.
- R&D teams developing new spring materials or geometries - for comparative mechanical behaviour during unloading and force–displacement profiling.
Related standards and practical notes
- Related ISO and EN standards on dental materials and device testing may be relevant for complementary requirements (consult national standards bodies or the CEN-CENELEC Management Centre for bibliographic references).
- For full compliance and detailed test procedures, refer to the full text of ISO 17254:2016 and ISO 17254:2016/Amd 1:2020 (EN ISO 17254:2016/A1:2021) and the manufacturer’s specified ranges cited in clauses 6.1 b) and 6.1 d).
Keywords: orthodontic coiled springs, ISO 17254, EN ISO 17254:2016/A1:2021, force–displacement test, type tests, dental materials, orthodontic springs testing, CEN.