What is ISO 21850‑1 about?
ISO 21850 discusses materials for dental instruments. ISO 21850‑1 applies to stainless steel materials used to manufacture either an entire instrument or a part of the instrument.
ISO 21850‑1 also applies to single-use and reusable dental instruments, whether it is or is not connected to a power-driven system.
Note: ISO 21850‑1 does not apply 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.
Who is ISO 21850‑1 for?
ISO 21850‑1 on materials for dental instruments (stainless steel dental instruments) is useful for:
- Manufacturers of stainless steel dental instruments
- Regulatory authorities
- Test centers for dental instruments
- Quality control personnel
Why should you use ISO 21850‑1?
There is an increasing number of newly developed dental surgical techniques with an increasing number of procedures. The market for dental instruments is also rapidly growing with demands for new and better instruments.
ISO 21850‑1 guidelines help you with requirements, selection of materials, and pre-clinical evaluations for stainless steel dental instruments. This helps in harmonizing the approval procedures. ISO 21850‑1 also helps in reducing the costs caused by repeated approval and test procedures with regard to the stainless steel materials used in dental instruments. ISO 21850‑1 contains a current selection of stainless steels suitable for use in the manufacture of dental instruments.