EN ISO 23401-1:2023 PDF

Dentistry - Chairside denture base relining materials - Part 1: Hard type materials (ISO 23401-1:2023)

Название (английский):

EN ISO 23401-1:2023

Dentistry - Chairside denture base relining materials - Part 1: Hard type materials (ISO 23401-1:2023)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 20
Дата публикации:: 29 марта 2023 г.
Издание:: CEN EN 23401 edition 1 version 1
ICS:: 11.060.10

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Описание (английский):

This document specifies the requirements for acrylic hard type materials used as chairside denture base relining materials and the test methods to determine compliance with these requirements. This document also specifies requirements for packaging and marking the products and for the instructions for use to be supplied by the manufacturer. Dentures which are relined by chairside denture base relining materials specified by this document are limited to those of acrylic. This document is not applicable to either denture base relining materials that are for laboratory use or soft lining materials. NOTE 1 Acrylic hard type materials contain acrylic and methacrylic monomers such as acrylic acid esters and substituted (meth)acrylic acid esters and their polymers. NOTE 2 Acrylic dentures are made of polymers such as poly (acrylic acid esters), poly (substituted acrylic acid esters) and rubber-modified poly (methacrylic acid esters).

Технические детали

Технический комитет: CEN/TC 55 - Dentistry
SKU: EN ISO 23401-1:2023

Abstract

Overview

EN ISO 23401-1:2023 - "Dentistry - Chairside denture base relining materials - Part 1: Hard type materials" is a CEN-endorsed international standard that specifies requirements and test methods for acrylic hard type chairside denture relining materials. It covers material composition (acrylic and methacrylic monomers and polymers), sampling, testing, packaging, marking and manufacturer instructions. The standard applies only to acrylic dentures relined chairside and is not applicable to laboratory-use relining materials or soft lining materials.

Key topics and requirements

Scope and classification
- Defines the hard-type classification and limits application to acrylic denture bases.
Material composition
- Notes that hard-type materials contain acrylic/methacrylic monomers (e.g., (meth)acrylic esters) and their polymers.
Performance requirements
- Visual appearance, consistency for intra-oral handling, peak exothermic temperature during polymerization, porosity and defects, surface finish.
- Physical properties testing: water sorption, water solubility, and Knoop hardness.
Test methods and specimen preparation
- Detailed procedures for sampling, specimen preparation, conditioning and testing (consistency, peak temperature, sorption/solubility, hardness).
Packaging, marking and instructions for use
- Requirements for labeling, user instructions and safe handling information to be supplied by the manufacturer.
Safety and biological considerations
- While specific toxicological limits are not provided, the standard recommends referencing ISO 10993-1 and ISO 7405 for biological evaluation.

Practical applications

Manufacturers: Use EN ISO 23401-1:2023 to design, test and certify chairside hard relining products to meet harmonized European and international quality requirements.
Regulators and conformity assessors: Adopt this standard for product approval, market surveillance and regulatory compliance checks.
Dental clinicians and prosthodontists: Understand material performance expectations (handling, intra-oral polymerization temperature, durability) when selecting chairside acrylic relining systems.
Purchasing and procurement: Specify compliant materials in tenders and procurement to ensure safety and consistent clinical performance.

Related standards

ISO 10139-1 / ISO 10139-2 - standards for soft lining materials (distinct from this hard-type document).
ISO 20795-1 / ISO 20795-2 - denture base material standards with different polymerization and property requirements.
ISO 10993-1 and ISO 7405 - guidance for biological and toxicological evaluation of dental materials.

Keywords: EN ISO 23401-1:2023, chairside denture base relining materials, hard type materials, acrylic relining, dentistry standards, test methods, water sorption, Knoop hardness.

Overview

Key topics and requirements

Scope and classification
- Defines the hard-type classification and limits application to acrylic denture bases.
Material composition
- Notes that hard-type materials contain acrylic/methacrylic monomers (e.g., (meth)acrylic esters) and their polymers.
Performance requirements
- Visual appearance, consistency for intra-oral handling, peak exothermic temperature during polymerization, porosity and defects, surface finish.
- Physical properties testing: water sorption, water solubility, and Knoop hardness.
Test methods and specimen preparation
- Detailed procedures for sampling, specimen preparation, conditioning and testing (consistency, peak temperature, sorption/solubility, hardness).
Packaging, marking and instructions for use
- Requirements for labeling, user instructions and safe handling information to be supplied by the manufacturer.
Safety and biological considerations
- While specific toxicological limits are not provided, the standard recommends referencing ISO 10993-1 and ISO 7405 for biological evaluation.

Practical applications

Manufacturers: Use EN ISO 23401-1:2023 to design, test and certify chairside hard relining products to meet harmonized European and international quality requirements.
Regulators and conformity assessors: Adopt this standard for product approval, market surveillance and regulatory compliance checks.
Dental clinicians and prosthodontists: Understand material performance expectations (handling, intra-oral polymerization temperature, durability) when selecting chairside acrylic relining systems.
Purchasing and procurement: Specify compliant materials in tenders and procurement to ensure safety and consistent clinical performance.

Related standards

ISO 10139-1 / ISO 10139-2 - standards for soft lining materials (distinct from this hard-type document).
ISO 20795-1 / ISO 20795-2 - denture base material standards with different polymerization and property requirements.
ISO 10993-1 and ISO 7405 - guidance for biological and toxicological evaluation of dental materials.

Keywords: EN ISO 23401-1:2023, chairside denture base relining materials, hard type materials, acrylic relining, dentistry standards, test methods, water sorption, Knoop hardness.

EN ISO 23401-1:2023 PDF

Технические детали

Abstract

Overview

Key topics and requirements

Practical applications

Related standards

Похожие стандарты

Abstract

Overview

Key topics and requirements

Practical applications

Related standards

Похожие стандарты

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