ISO 10139-2:2016 PDF

Name: ISO 10139-2:2016 — Dentistry — Soft lining materials for removable dentures — Part 2: Materials for long-term use
SKU: ISO 10139-2:2016
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Dentistry — Soft lining materials for removable dentures — Part 2: Materials for long-term use

Название (английский):

ISO 10139-2:2016

Dentistry — Soft lining materials for removable dentures — Part 2: Materials for long-term use

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 12
Дата публикации:: 10 июня 2016 г.
Издание:: ISO IS 10139 edition 3 version 1
ICS:: 11.060.10

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Описание (английский):

ISO 10139-2:2016 specifies requirements for softness, adhesion, water sorption and water solubility, as well as for packaging, marking and manufacturer's instructions for soft denture lining materials suitable for long-term use. These materials may also be used for maxillofacial prostheses.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 10139-2:2016 - Dentistry: Soft lining materials for removable dentures (Part 2: Materials for long-term use) specifies performance and labeling requirements for soft denture lining materials intended for long-term use (greater than 30 days). The standard covers mechanical and physical properties, test methods, and requirements for packaging, marking and manufacturer’s instructions. These lining materials can also be used in maxillofacial prostheses.

Key topics and requirements

Classification by softness

Type A (soft): 24 h Shore A hardness >25 and ≤50
Type B (extra soft): 24 h Shore A hardness ≤25

Shore A hardness tests

Measurements at 24 hours and 30 days after conditioning; tests use ISO 7619‑1 durometer method and specimens are conditioned in water (37 ±1 °C).
Limits at 30 days: Type A ≤55, Type B ≤35 (5 s reading).

Bond strength to denture base

Minimum bond strength when tested: ≥1.0 MPa for Type A and ≥0.5 MPa for Type B for at least 8 of 10 specimens.

Water sorption and solubility

Water sorption: increase in mass per volume shall not exceed 20 µg/mm for at least 4 of 5 specimens.
Water solubility: loss in mass per volume shall not exceed 3 µg/mm for at least 4 of 5 specimens. If exceeded in ≥2 specimens, the manufacturer must disclose amount and nature of solubles.

Testing and sampling

Specifies specimen preparation, storage, test conditions and statistical pass/fail criteria.

Packaging, marking and instructions

Requirements for immediate container labeling and user instructions to ensure correct clinical application and safe handling.

Practical applications

Ensures consistent quality and predictable clinical behavior of soft denture liners used for tissue cushioning, retention improvement, and patient comfort.

Supports product development and quality control for dental-material manufacturers, including formulation, batch testing and labeling.

Guides dental laboratories and prosthodontists in selecting materials appropriate for prostheses that require long-term resilience and adhesion.

Aids regulatory bodies and testing laboratories in certifying conformity to international test methods and performance thresholds.

Related standards

ISO 10139-1 (short-term use)

ISO 7619-1 (Shore hardness test)

ISO 20795-1 (denture base polymers)

ISO 7405 and ISO 10993-1 (biocompatibility guidance)

ISO 3696 (water for analytical use)

Keywords: ISO 10139-2:2016, soft denture lining, long-term use, Shore A hardness, bond strength, water sorption, water solubility, maxillofacial prostheses, dental materials.

ISO 10139-2:2016 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Practical applications

Who uses this standard

Related standards

Технические детали

ISO 7619-1:2004/Amd 1:2008

Rubber, vulcanized or thermoplastic — Determination of indentation hardness — Part 1: Durometer method (Shore…

SIST EN ISO 10139-1:2018

Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:…

SIST EN ISO 20795-1:2013

Dentistry - Base polymers - Part 1: Denture base polymers (ISO 20795-1:2013)

SIST EN ISO 7405:2025

Dentistry - Evaluation of biocompatibility of medical devices used in dentistry (ISO 7405:2025)

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 3696:1998

Water for analytical laboratory use - Specification and test methods (ISO 3696:1987)