EN ISO 13402:2025 PDF

Overview - EN ISO 13402:2025

EN ISO 13402:2025 - titled Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure (ISO 13402:2025) - defines harmonized type test methods to assess the resistance of stainless steel surgical and dental hand instruments to autoclaving, corrosion and thermal exposure. Approved by CEN in March 2025, this second edition supersedes the 2000/2001 edition and compiles standardized procedures for evaluating instrument surface integrity and material stability.

Key topics and technical requirements

• Scope: Test methods apply to stainless steel instruments (martensitic, austenitic, ferritic and precipitation‑hardening steels) to determine resistance to sterilization, corrosion and thermal stress.
• Type tests: All procedures in the standard are defined as type tests (not routine production checks).
• Sampling plan: Manufacturers must define sampling according to ISO 7554-3 to ensure representative testing; rejected lots can be re‑passivated and re‑tested.
• Test methods (Annexes A–H):
  • Boiling tests (Annex A - deionized water; Annex B - 0.9 % NaCl) to detect surface imperfections and free iron.
  • Copper sulfate tests (Annex C for ≥16 % Cr steels; Annex D for martensitic