Draft
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.
Legislation related to this standard
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
IN_DEVELOPMENT
prEN ISO 21850-2
45.99
Dispatch of FV draft to CCMC
Feb 3, 2025
