ISO 21850-1-2020 PDF

Full title and description

ISO 21850-1:2020 — Dentistry — Materials for dental instruments — Part 1: Stainless steel. This international standard specifies stainless steels commonly used in the manufacture of dental instruments (single‑use and reusable), and provides a current selection of stainless steel grades suitable for dental instruments.

Abstract

The standard lists stainless steel materials appropriate for complete instruments or instrument parts used in dentistry, whether or not the instrument is motor‑driven. It excludes materials used long‑term in the patient’s mouth (for example crowns, bridges, implants) and instruments not made of stainless steel. The document is intended to guide material selection for corrosion resistance, mechanical performance and suitability for dental manufacturing and reprocessing.

General information

• Status: Published (International Standard, confirmed in ISO five‑year review).
• Publication date: April 2020 (Edition 1, 2020).
• Publisher: International Organization for Standardization (ISO).
• ICS / categories: 11.060.20 (Dental equipment).
• Edition / version: Edition 1 (2020).
• Number of pages: 16 pages (published PDF length as listed by ISO).

Scope

ISO 21850‑1:2020 applies to stainless steel materials used to manufacture an entire dental instrument or part of an instrument. It covers both single‑use and reusable instruments, whether or not connected to a power‑driven system. It does not apply to long‑term intra‑oral devices (crowns, bridges, implants) or to instruments not made of stainless steel. The standard provides a current selection of stainless steel grades deemed suitable for dental instrument manufacture and informs selection for corrosion resistance, strength and reprocessing capability.

Key topics and requirements

• Identification of stainless steel grades commonly acceptable for dental instruments.
• Material selection guidance for single‑use and reusable instruments (suitability and limitations).
• Considerations of corrosion resistance and mechanical performance relevant to dental use.
• General guidance on material condition/heat treatment and surface condition relevant to instrument function and reprocessing.
• Exclusions and limits (not applicable to long‑term intra‑oral devices or non‑stainless‑steel instruments).

Typical use and users

Primary users include dental instrument manufacturers, material and metallurgical engineers, product designers, quality and compliance teams in medical device companies, testing laboratories, procurement specialists, and standards/technical committees in dentistry and medical device regulation. The standard is used when selecting stainless steels for new instrument designs, for revision of existing instrument material specifications, and for procurement specifications.

Related standards

ISO 21850 is a multi‑part series covering materials for dental instruments. Part 2 (Polymers) has since been published as ISO 21850‑2 (2025) and complements Part 1 by specifying polymers commonly used for dental instrument manufacture. The series is developed by ISO/TC 106/SC 4 (Dentistry). National and regional adoptions (for example EN/ISO adoptions) exist for parts of this series.

Keywords

ISO 21850, dental instruments, stainless steel, dental materials, corrosion resistance, reusable instruments, single‑use instruments, material selection, ISO/TC 106.

FAQ

Q: What is this standard?

A: ISO 21850‑1:2020 is an international standard that specifies stainless steels commonly used in the manufacture of dental instruments.

Q: What does it cover?

A: It covers selection and specification of suitable stainless steel grades for complete dental instruments or instrument parts (single‑use and reusable), and states exclusions such as long‑term intra‑oral devices and non‑stainless‑steel instruments.

Q: Who typically uses it?

A: Dental instrument manufacturers, material engineers, product designers, quality and regulatory teams, testing labs and procurement specialists use the standard for material selection, specifications and compliance.

Q: Is it current or superseded?

A: It is current. ISO lists ISO 21850‑1:2020 as published and notes the standard was reviewed and confirmed in the ISO review cycle (confirmed status). An amendment project for Part 1 is also in development.

Q: Is it part of a series?

A: Yes — ISO 21850 is a multi‑part series for materials for dental instruments. Part 2 (Polymers) has been published (ISO 21850‑2, 2025) and other parts or amendments may be developed by ISO/TC 106/SC 4.

Q: What are the key keywords?

A: stainless steel, dental instruments, dental materials, corrosion resistance, reusable instruments, single‑use instruments, ISO 21850.