ISO 10139-2-2016 PDF

Full title and description

ISO 10139-2:2016 — Dentistry — Soft lining materials for removable dentures — Part 2: Materials for long-term use. This International Standard specifies performance requirements, test methods and labelling/packaging/manufacturer’s instructions for soft denture lining materials intended for long‑term clinical use (typically > 30 days). The materials covered may also be used for maxillofacial prostheses.

Abstract

Specifies requirements for softness (hardness), adhesion to denture base materials, water sorption and water solubility, and sets requirements for packaging, marking and manufacturer's instructions for soft lining materials suitable for long‑term use. Test methods and acceptance criteria are given to ensure durability and predictable clinical performance.

General information

• Status: Published.
• Publication date: June 2016 (2016-06).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.060.10 (Dental materials).
• Edition / version: 3rd edition (ISO 10139-2:2016).
• Number of pages: 12 pages.

Summary details above are taken from the ISO bibliographic record for ISO 10139-2:2016.

Scope

Applies to soft lining materials intended for long‑term use in removable dentures (commonly defined as service life greater than about 30 days). The standard defines classification, required physical properties, limits and test procedures for hardness, adhesion to denture base substrates, and limits for water sorption and solubility, and includes requirements for packaging, marking and manufacturer's instructions. The materials may also be applied in certain maxillofacial prosthetic uses.

Key topics and requirements

• Classification by intended use (long‑term liners) and by softness (Type A / Type B) with Shore A hardness measurement requirements (tests at 24 h and after conditioning).
• Hardness (Shore A) test methods referenced (durometer method and related ISO test references) and classification thresholds for soft vs extra‑soft materials.
• Adhesion/bond strength requirements to denture base substrates (minimum tensile bond strength criteria referenced in guidance and literature for long‑term liners; practical acceptance criteria are discussed in technical literature).
• Limits and test methods for water sorption and water solubility to assess dimensional and property stability in service.
• Requirements for packaging, labelling, and manufacturer's instructions for safe and effective clinical use (including shelf information, mixing/curing/use instructions and intended duration).

Typical use and users

Primary users include dental materials manufacturers, quality/control laboratories, dental laboratories and prosthodontists specifying or using long‑term soft liners, regulatory bodies and conformity assessment organizations, and dental materials researchers. The standard is also adopted or referenced by national bodies and professional organizations when setting product specifications or acceptance criteria.

Related standards

ISO 10139 is a multipart series. The principal related part is ISO 10139-1 (Materials for short‑term use). National and regional adoptions (for example EN ISO 10139-2:2016) and related dental material standards (ICS 11.060.10) should be consulted for harmonized application and for complementary test methods.

Keywords

soft lining materials; denture liners; long‑term soft liners; prosthodontics; Shore A hardness; adhesion; water sorption; water solubility; denture base bonding; dental materials standards.

FAQ

Q: What is this standard?

A: An ISO International Standard specifying performance, test methods and labelling/packaging/manufacturer instructions for long‑term soft lining materials used with removable dentures (ISO 10139‑2:2016).

Q: What does it cover?

A: Requirements for softness/hardness classification, adhesion to denture base substrates, water sorption and solubility limits, and the information that must appear on packaging and instructions for materials intended for long‑term clinical use. Test methods and acceptance criteria are provided or referenced.

Q: Who typically uses it?

A: Dental materials manufacturers, dental laboratories, prosthodontists and clinicians specifying liners, test laboratories, regulators and researchers concerned with selection, manufacture and evaluation of long‑term soft denture lining materials. National standard bodies and dental associations also reference it when creating national specifications.

Q: Is it current or superseded?

A: ISO 10139‑2:2016 is the 3rd edition published in June 2016; it replaced earlier editions and remains the published version subject to ISO's periodic review cycle (standards are reviewed approximately every 5 years). Users should check national adoption status and any amendments or revisions since 2016 before assuming the text is unchanged.

Q: Is it part of a series?

A: Yes — ISO 10139 is a multipart series covering soft lining materials for removable dentures; part 1 covers materials for short‑term use and part 2 covers long‑term use, with national/regional adoptions (EN/ANSI) commonly available.

Q: What are the key keywords?

A: Soft lining materials, denture liners, long‑term liners, Shore A hardness, adhesion/bond strength, water sorption, water solubility, dental materials standards.