This document specifies requirements of dental implant surgical guide produced by 3D printing or other methods such as press polymerizing. 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.
NOTE: If the word "harmonized" (marked in green) is not found in the field with the name of the directive, it means that the European standard is not cited in the OJEU.
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
ABANDON
delSRPS EN ISO 8172:2022
30.98
Project deleted
Sep 17, 2024