Overview
EN ISO 28319:2018 (ISO 28319:2018) is the international/CEN standard that specifies requirements and test methods for laser welding and the filler materials used in the dental laboratory for welding metallic restorations and appliances. This second edition (2018) supersedes the 2010 version and standardizes composition reporting, biocompatibility, mechanical and corrosion testing, and the information manufacturers must provide with filler materials.
Key Topics and Requirements
- Scope and definitions: Defines laser welding and filler material terminology applicable to dental prosthodontic work.
- Chemical composition: Manufacturers must declare the percentage by mass of all elements present in excess of 1.0%, reported to a precision of 0.1%.
- Biocompatibility: Filler materials and welded joints are subject to biocompatibility requirements appropriate for dental materials.
- Mechanical strength: Tensile strength of laser-welded joints is specified and evaluated using standardized specimen preparation and tensile testing procedures.
- Corrosion resistance: Static immersion corrosion testing and post-exposure appearance inspection are specified; the 2018 edition references ISO 10271:2011 for corrosion test methods and includes a corrosion limit for static tests.
- Process guidance: Annex A (informative) describes the laser welding process, seam geometry and welding considerations.
- Sampling, preparation and test methods: Detailed procedures for specimen sampling, visual inspection, chemical analysis, tensile testing, and microscopic inspection after corrosion testing.
- Instructions, marking and labelling: Requirements for the information to be provided with filler materials (instructions for use), plus marking and labelling rules consistent with medical device symbol standards (e.g., ISO 15223-1).
Practical Applications
- Standardizes quality and safety for laser welding operations in dental laboratories.
- Guides selection and testing of welding rods/filler materials used to join similar or dissimilar dental alloys.
- Ensures welded restorations and appliances meet mechanical, corrosion and biocompatibility expectations before clinical use.
- Supports documentation and labelling compliance for manufacturers, improving traceability and safe use in dental practice.
Who Should Use This Standard
- Dental laboratory managers and prosthodontic technicians performing laser welding
- Manufacturers of dental filler materials and welding consumables
- Test laboratories performing tensile and corrosion testing for dental materials
- Regulatory bodies and conformity assessment organizations evaluating dental restorative materials
Related Standards
Keywords: ISO 28319:2018, dentistry, laser welding, filler materials, dental laboratory, corrosion testing, tensile strength, biocompatibility, marking and labelling.