ISO 10139-1-2018 PDF

Full title and description

ISO 10139-1:2018 — Dentistry — Soft lining materials for removable dentures — Part 1: Materials for short-term use. This International Standard specifies requirements for physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials intended for short-term applications, including functional impression taking using an existing removable prosthesis.

Abstract

ISO 10139-1:2018 defines performance requirements and standardized test methods for short‑term soft lining materials used with removable dentures. It covers the measurable physical and dimensional characteristics required for product acceptance, plus requirements for packaging, labeling and manufacturer instructions to ensure safe, effective short‑term clinical use and reproducible testing. The standard supports consistency across manufacturers and laboratories assessing short‑term soft lining materials.

General information

• Status: Published and confirmed (reviewed and confirmed in 2023; remains current).
• Publication date: March 2018 (ISO edition 3, published 2018-03).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.060.10 — Dental materials (ISO/TC 106/SC 2).
• Edition / version: Edition 3 (2018).
• Number of pages: 10 (ISO published text: 10 pages).

Scope

This part of ISO 10139 specifies requirements for soft lining materials intended for short‑term use in removable dentures. The scope includes defining the applicable material categories, required physical properties, standardized test methods, sampling, and the requirements for packaging, marking and manufacturer's instructions relevant to short‑term clinical and laboratory use (including use for functional impression taking with an existing removable prosthesis). It does not cover long‑term lining materials (see Part 2).

Key topics and requirements

• Definitions and classification of soft lining materials intended for short‑term use (material types and intended applications).
• Specified physical property requirements (e.g., hardness/softness, tensile/elongation characteristics, dimensional stability and behaviour in water).
• Standardized test methods for evaluating the above properties and for sampling test specimens.
• Requirements for water sorption and solubility (performance after exposure to aqueous environments) and related conditioning procedures.
• Adhesion/bonding performance to denture base materials and related test considerations.
• Requirements for packaging, marking and clear manufacturer’s instructions for safe and effective short‑term clinical use (including storage, mixing/processing, and clinical application notes).
• Sampling, conformity assessment language and document structure to ensure reproducible laboratory testing and manufacturer declarations.

Typical use and users

Primary users of ISO 10139-1:2018 include dental materials manufacturers, product development and quality laboratories, dental prosthetics laboratories, dentists and prosthodontists involved in selecting or specifying short‑term soft lining materials, and regulatory or conformity assessment bodies reviewing dental material performance documentation. The standard is used to specify product acceptance criteria, to design or interpret laboratory tests, and to support regulatory submissions or internal quality programs.

Related standards

ISO 10139 is a multipart series. Closely related standards include ISO 10139-2 (Dentistry — Soft lining materials for removable dentures — Part 2: Materials for long‑term use), which covers long‑term soft lining materials and their specific performance requirements (softness, adhesion, water sorption and solubility). Other related documents include national/adopted versions and regional EN/ISO adoptions of both parts.

Keywords

ISO 10139-1, dentistry, soft lining materials, denture lining, removable dentures, short‑term use, test methods, water sorption, solubility, packaging, marking, dental materials, ISO/TC 106.

FAQ

Q: What is this standard?

A: ISO 10139-1:2018 is an International Standard that specifies requirements and test methods for soft lining materials intended for short‑term use in removable dentures, covering performance characteristics, packaging, marking and manufacturer's instructions.

Q: What does it cover?

A: It covers material classification for short‑term soft denture linings, required physical properties and how to test them (conditioning, sampling and test methods), and requirements for packaging, labeling and instructions needed for safe and effective short‑term clinical use. It excludes materials intended for long‑term use (addressed in Part 2).

Q: Who typically uses it?

A: Manufacturers of dental lining materials, product development and quality control laboratories, dental prosthetics technicians, clinicians specifying or using soft liners for short‑term applications, and conformity assessment or regulatory personnel.

Q: Is it current or superseded?

A: ISO 10139-1:2018 is the current edition (Edition 3, published March 2018). The ISO record shows it was last reviewed and confirmed (remains current) in 2023. Previous editions (for example 2005) were withdrawn and replaced by the 2018 edition.

Q: Is it part of a series?

A: Yes — ISO 10139 is multipart. Part 1 addresses materials for short‑term use (this document). Part 2 addresses materials for long‑term use (ISO 10139-2, current edition published 2016), and both parts are managed by ISO/TC 106/SC 2.

Q: What are the key keywords?

A: Soft lining materials, denture lining, removable dentures, short‑term, dental materials, test methods, water sorption, solubility, packaging, marking, ISO 10139-1.