EN ISO 20795-2:2013 PDF

Name: EN ISO 20795-2:2013 — Dentistry - Base polymers - Part 2: Orthodontic base polymers (ISO 20795-2:2013)
SKU: EN ISO 20795-2:2013
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Dentistry - Base polymers - Part 2: Orthodontic base polymers (ISO 20795-2:2013)

Название (английский):

EN ISO 20795-2:2013

Dentistry - Base polymers - Part 2: Orthodontic base polymers (ISO 20795-2:2013)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 39
Дата публикации:: 6 марта 2013 г.
Издание:: CEN EN 20795 edition 2 version 1
ICS:: 11.060.10

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Описание (английский):

ISO 20795-2:2013 is applicable to orthodontic base polymers and copolymers used in the construction of both active and passive orthodontic appliances and specifies their requirements. It also specifies test methods to be used in determining compliance with these requirements. It further specifies requirements with respect to packaging and marking the products and to the instructions to be supplied for use of these materials.

Abstract

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Стандарты, упомянутые в описании

Overview

EN ISO 20795-2:2013 - Dentistry: Base polymers - Part 2: Orthodontic base polymers (ISO 20795-2:2013) sets out requirements and test methods for orthodontic base polymers and copolymers used in removable active and passive orthodontic appliances. Prepared by ISO/TC 106 in collaboration with CEN, the standard defines material classification, processing and inspection criteria, laboratory specimen preparation, testing procedures, and requirements for packaging, marking and instructions for use.

Key topics and technical requirements

Scope and classification - Covers three material types: autopolymerizable, light‑activated, and thermoplastic orthodontic base polymers.

Unpolymerized material - Requirements for liquid (monomer) and solid (powder) components, including homogeneity and freedom from visible contamination.

Polymerized material properties - Surface finish (smooth, hard, glossy), shape capability, colour stability and even pigmentation when coloured.

Mechanical and physical tests - Standard specifies methods for:

Polishability, porosity, flexural strength and flexural modulus
Fracture toughness (modified bending test)
Residual methyl methacrylate (MMA) monomer content (including an HPLC method in Annex A)
Plasticiser content (where applicable)
Water sorption and solubility

Sampling and specimen preparation - Detailed laboratory conditions and procedures for making test specimens to ensure reproducible results.

Packaging, marking and instructions - Requirements for outer packaging, immediate containers, labelling and user instructions to support safe and effective use.

Practical applications and users

Dental materials manufacturers for product development, quality control and conformity assessment of orthodontic base polymers.

Orthodontic and dental laboratories to select and process materials consistent with standardized performance expectations.

Testing laboratories to perform accredited mechanical, chemical and physical testing (e.g., residual monomer by HPLC, water sorption).

Regulatory and procurement bodies assessing product documentation, labelling and compliance.

Clinicians and dental technicians seeking assurance about material behaviour (polishability, dimensional stability, residual monomer risk) for removable orthodontic appliances.

Related standards

ISO 20795-1 (Denture base polymers)

ISO 10993-1 and ISO 7405 (biocompatibility/toxicological assessment guidance)

ISO 7491 (colour stability)

ISO 3696 and ISO 1942 (laboratory water and dentistry vocabulary)

EN ISO 20795-2:2013 provides a practical, test‑driven framework for ensuring that orthodontic base polymers meet consistent performance, safety and labelling expectations across manufacturing and clinical use.

EN ISO 20795-2:2013 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

ISO 20795-2:2013

Dentistry — Base polymers — Part 2: Orthodontic base polymers

SIST EN ISO 20795-1:2013

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

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

SIST EN ISO 7405:2025

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SIST EN ISO 7491:2001

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SIST EN ISO 3696:1998

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

BS ISO 19426-3:2018

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