ISO 10139-1:2018

Overview

ISO 10139-1:2018 - "Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use" specifies physical property requirements, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials intended for short-term clinical use (normally 60 minutes to 30 days). The standard covers products used as tissue conditioners, temporary soft linings and materials indicated for functional impression taking with existing removable prostheses.

Key topics and technical requirements

• Classification
  • Type A (soft): Shore A0 hardness 30 < Shore A0 ≤ 50 (at 2 h)
  • Type B (extra soft): Shore A0 ≤ 30 (at 2 h)
  • Classes by flow (consistency):
    • Class 1 - medium flow: diameter 25 ≤ d < 60 mm
    • Class 2 - high flow: diameter 60 ≤ d < 100 mm
• Hardness testing
  • Uses Shore A0 durometer (ISO 7619-1 method)
  • Specimens: three per test, 50–55 mm diameter, 8 ± 0.5 mm thickness
  • Measurements at 2 hours (after 15 min post-mix and 2 h in 37 ± 1 °C water) and 7 days; mean at 7 d must be ≤ 60
  • Five indentations per specimen, specified spacing and location
• Consistency (flow) test
  • Defines flow classes based on diameter of spread under controlled conditions
• Detail reproduction
  • Applies to materials claimed for functional impression taking; minimum detail reproduction: 75 µm (line c of ISO 4823)
• Testing environment and sampling
  • Ambient test conditions: 23 ± 2 °C, RH 30–70%
  • Water bath for immersion: 37 ± 1 °C
  • Sampling: retail packages from the same batch
• Packaging, marking and instructions
  • Requirements for manufacturer’s labeling and user instructions are specified to ensure safe and effective clinical use

Applications and who uses this standard

• Dental manufacturers formulating soft lining materials and impression materials
• Product development, quality control and regulatory teams in dental materials companies
• Dental laboratories and prosthodontists selecting temporary soft linings or tissue conditioners
• Test laboratories conducting conformity and performance testing for short-term denture liners
• Notified bodies and regulators assessing compliance with dental material standards

Related standards

• ISO 4823:2015 - Elastomeric impression materials (detail reproduction)
• ISO 7619-1 - Durometer method (Shore hardness)
• ISO 10993-1, ISO 7405 - Biological evaluation guidance (recommended for biocompatibility)
• ISO 3696 - Water for analytical use
• ISO 10139 series - other parts covering long-term materials and additional specifications

Keywords: ISO 10139-1:2018, soft denture lining materials, short-term use, Shore A0 hardness, consistency test, functional impression, tissue conditioner, removable dentures, dental standards.