Overview
EN ISO 10139-1:2018 - Dentistry: Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2018) specifies requirements for soft denture lining materials intended for short-term use. Published by CEN and identical to ISO 10139-1:2018, this standard covers physical property requirements, test methods, sampling, packaging, marking and manufacturer’s instructions, including provisions where materials are used for functional impression taking with existing removable prostheses.
Key topics and technical requirements
- Scope and definition
- Applies to soft lining materials used for short-term use (defined as normally between 60 minutes and 30 days).
- Includes tissue conditioners, temporary soft linings and materials used for functional impressions.
- Performance requirements
- Specifies physical property tests designed to ensure material performance over a 7-day evaluation period (recognizing some clinical uses extend beyond 7 days).
- Principal test methods
- Shore A0 hardness testing (replaces the older depth-penetration test) - measured at 2 hours and 7 days to assess initial and short-term hardness (see ISO 7619-1 for durometer method).
- Consistency test - reintroduced to evaluate flow/handling behavior (replaces the elastic recovery test).
- Detail reproduction test - adopted from ISO 4823 to assess ability to record functional impressions.
- Other procedural elements: sampling, ambient testing conditions, apparatus and step-by-step procedures are specified.
- Packaging, marking and instructions
- Requirements for labeling, instructions for use, and packaging to ensure correct storage, mixing, preparation and clinical application.
- Biocompatibility
- The standard does not prescribe specific biological test methods but recommends referring to ISO 10993-1 and ISO 7405 for biological hazard assessment.
Practical applications
- Selecting and specifying short-term soft lining materials for:
- Tissue conditioning to restore mucosal health.
- Temporary linings in immediate dentures or during implant treatment phases.
- Functional impression taking using existing removable prostheses.
- Ensuring product documentation (instructions, labeling) and laboratory/clinical testing align with recognized international methods.
Who should use this standard
- Dental materials manufacturers and R&D teams
- Dental laboratories and prosthodontists
- Regulatory and procurement professionals specifying dental products
- Test laboratories performing material conformity testing
- Standards committees and clinical researchers
Related standards
EN ISO 10139-1:2018 is essential when evaluating, manufacturing or procuring soft denture lining materials for short-term clinical use, providing standardized test methods and labeling requirements to support safety, performance and regulatory compliance.