ISO 20795-2:2013 PDF

Name: ISO 20795-2:2013 — Dentistry — Base polymers — Part 2: Orthodontic base polymers
SKU: ISO 20795-2:2013
Price: 25 EUR
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Dentistry — Base polymers — Part 2: Orthodontic base polymers

Название (английский):

ISO 20795-2:2013

Dentistry — Base polymers — Part 2: Orthodontic base polymers

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 31
Дата публикации:: 26 февраля 2013 г.
Издание:: ISO IS 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

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 20795-2:2013 - "Dentistry - Base polymers - Part 2: Orthodontic base polymers" defines requirements and test methods for orthodontic base polymers and copolymers used in the construction of both active and passive removable orthodontic appliances. The standard covers material types, specimen preparation, mechanical and chemical property limits, packaging, marking and manufacturer instructions, and specific test procedures (including an HPLC method for residual methyl methacrylate).

Key Topics and Requirements

Scope and classification

Applies to materials used for orthodontic bases (removable appliances).
Classifies materials into three types: Type 1 (autopolymerizable), Type 2 (light-activated), Type 3 (thermoplastic).

Mechanical performance

Ultimate flexural strength: not less than 50 MPa.
Flexural modulus: at least 1 500 MPa.
Fracture properties: minimum total fracture work and stress intensity factor specified (see Table 1 of the standard).

Chemical safety and composition

Residual methyl methacrylate (MMA): maximum mass fraction 5 % when tested per the standard.
Plasticizers: extractable phthalate plasticizers must be identified and quantified; content must not exceed the manufacturer’s stated value by more than 10 %.

Durability and stability

Water sorption and solubility: limits specified for processed polymer (water sorption ≤ 32 µg/mm, solubility ≤ 5 µg/mm in the standard’s expression).

Surface and aesthetic requirements

Processed specimens must present a smooth, hard, glossy surface, retain form without distortion, and meet declared colour/transparency.

Test methods & specimen preparation

Procedures for sampling, specimen plates, environmental conditions (typically 23 ± 2 °C and 50 ± 10 % RH) and inspection are specified.
Annex A includes an HPLC method for determining MMA content.

Packaging, labelling and instructions

Requirements for immediate and outer packaging, marking and mandatory manufacturer’s instructions.

Applications and Users

ISO 20795-2:2013 is used by:

Manufacturers of orthodontic base materials for product development, quality control and labelling compliance.

Dental laboratories and technicians who process removable orthodontic appliances.

Independent test laboratories performing compliance and safety testing (mechanical, chemical).

Regulatory bodies and procurement teams evaluating material specifications and safety claims.

Clinicians and dental product purchasers seeking materials with documented performance limits.

Related Standards

ISO 20795-1 (Denture base polymers)

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

ISO 7491 (colour stability)

ISO 1942, ISO 3696, ISO 8601 (referenced for terminology, lab water and data formats)

Keywords: ISO 20795-2:2013, orthodontic base polymers, dental materials, residual methyl methacrylate, flexural strength, water sorption, fracture toughness, HPLC, packaging and labelling.

ISO 20795-2:2013 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Applications and Users

Related Standards

Технические детали

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

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

SIST EN ISO 7491:2001

Dental materials - Determination of colour stability (ISO 7491:2000)

BS ISO 19426-3:2018

Structures for mine shafts. Sinking stages.

SIST EN ISO 3696:1998

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

ISO 8601-1:2019/Amd 1:2022

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