ISO 10873:2021

Overview

ISO 10873:2021 - Dentistry - Denture adhesives is an international standard that classifies denture adhesives used by wearers of removable dentures and specifies the requirements, test methods and user information that must accompany these consumer products. Applicable to consumer-market denture adhesives, the standard expressly excludes dental lining materials prescribed or applied by dental professionals. This is the second edition (2021), updating test procedures and some sample/ratio specifications from the 2010 edition.

Key topics and technical requirements

The standard defines classification, requirements and precise test methods (Clause 7). Major technical topics include:

• Classification
  • Type 1 (glue type) - Classes: powder (Class 1), cream (Class 2), sheet/tape (Class 3)
  • Type 2 (liner type)
• General requirements
  • Biocompatibility: assess potential biological effects, with specific attention to release of metallic ions
  • pH: adhesives shall have a pH between 4 and 10 when tested per Clause 7.2
  • Microbiology: contamination testing per appropriate microbiological methods
  • Stability: no deterioration after aging procedures (Clause 7.3)
• Type‑specific requirements
  • Type 1 (glue):
    • Washability: no residual lump after test (Clause 7.4)
    • Adhesion strength: ≥ 5 kPa (Clauses 7.5 and 7.6)
  • Type 2 (liner):
    • Adhesion strength: ≥ 5 kPa (Clause 7.7)
    • Peeling property: no residual lump after test (Clause 7.8)
    • Consistency: ≥ 15 mm (Clause 7.9)
• Testing conditions & sampling
  • Standard test temperature (23 ± 3) °C
  • pH measurement requires a pH meter (accuracy ±0.02)
  • Samples drawn from a single lot sufficient for all Clause 7 tests
• Packaging & information
  • Packaging, instructions for use and labelling requirements specified (Clauses 8 and 9)

Applications and practical value

ISO 10873:2021 provides objective, reproducible test methods and acceptance criteria to ensure safety, performance and consistent quality of denture adhesives. Practical applications include:

• Product development: formulation targets (pH, consistency, adhesion)
• Quality control & batch release testing for manufacturers
• Independent testing laboratories performing standardized adhesion, peeling and washability tests
• Regulatory compliance, import/export documentation and market surveillance
• Labeling, instructions for use and stability claims for marketing and consumer safety

Who should use this standard

• Denture adhesive manufacturers and R&D teams
• Dental product quality managers and compliance officers
• Contract testing and materials laboratories
• Regulatory authorities and notified bodies assessing consumer dental products
• Procurement and supply chain teams sourcing denture adhesives

Related standards

• ISO 7405 and ISO 10993‑1 (for biocompatibility assessment recommendations)
• ISO 1942 (dental vocabulary), ISO 3696 (water for analytical use), ISO 7823‑2 (PMMA sheets), ISO 8601‑1 (date/time representations)

Keywords: ISO 10873, denture adhesives, denture adhesive testing, denture adhesive requirements, dental standards, adhesion strength, denture adhesive classification.