EN ISO 10139-1:2018 PDF

Name: EN ISO 10139-1:2018 — Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2018)
SKU: EN ISO 10139-1:2018
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Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2018)

Название (английский):

EN ISO 10139-1:2018

Dentistry - Soft lining materials for removable dentures - Part 1: Materials for short-term use (ISO 10139-1:2018)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 18
Дата публикации:: 2 мая 2018 г.
Издание:: CEN EN 10139 edition 2 version 1
ICS:: 11.060.10

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Описание (английский):

ISO 10139-1:2018 specifies requirements for the physical properties, test methods, packaging, marking and manufacturer's instructions for soft denture lining materials suitable for short-term use, including functional impression taking using existing removable prosthesis.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

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.

Related standards

ISO 4823 - Elastomeric impression materials (detail reproduction)

ISO 7619-1 - Durometer/shore hardness testing

ISO 10993-1, ISO 7405 - Biocompatibility guidance

ISO 3696 - Water for analytical use

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.

EN ISO 10139-1:2018 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards

Технические детали

ISO 10139-1:2018

Dentistry — Soft lining materials for removable dentures — Part 1: Materials for short-term use

ISO 7619-1:2004/Amd 1:2008

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

SIST EN ISO 4823:2025

Dentistry - Elastomeric impression and bite registration materials (ISO 4823:2025)

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 7405:2025

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

SIST EN ISO 3696:1998

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