ISO 21850-1:2020 PDF

Scope: This document specifies stainless steel commonly used in manufacturing dental instruments. It is applicable to stainless steel materials used to manufacture either an entire instrument or a part of the instrument. It is applicable to single-use and reusable dental instruments, whether it is or it is not connected to a power-driven system. 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 stainless steel. It contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.

ISO 21850-1:2020 Referenced Document

ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
ISO 15510 Stainless steels - Chemical composition
ISO 1942 Dentistry — Vocabulary — Amendment 1
ISO 7405 Dentistry - Evaluation of biocompatibility of medical devices used in dentistry

2020 ISO 21850-1:2020 Dentistry — Materials for dental instruments — Part 1: Stainless steel