prEN ISO 21850-2

Dentistry - Materials for dental instruments - Part 2: Polymers (ISO/DIS 21850-2:2024) prEN ISO 21850-2

Publication date:   May 23, 2024

General information

40.60 Close of voting   Aug 12, 2024

CEN

CEN/TC 55 Dentistry

European Norm

11.060.25   Dental instruments

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Scope

This document specifies polymers commonly used in manufacturing dental instruments.
It is applicaple to polymers materials used to manufacture either an entire instrument or a part of the instrument.
It is applicable to single-use and reusable dental instruments, connected to a power-driven system or not.
This document is not applicable to devices and instruments used long-term in the mouth of the patient (e.g. crown, bridges, implants) or to devices and instruments not made of polymers.
It contains a current selection of polymers suitable for use in the manufacture of dental instruments.

Related legislation

Legislation related to this standard

2017/745

Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC

Life cycle

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IN_DEVELOPMENT
prEN ISO 21850-2
40.60 Close of voting
Aug 12, 2024