ISO 13402:2025

Overview

ISO 13402:2025 - "Surgical and dental hand instruments - Determination of resistance against autoclaving, corrosion and thermal exposure" defines a harmonized set of type test methods to assess the durability of stainless steel surgical and dental hand instruments under sterilization, corrosive and thermal conditions. The second edition updates and consolidates procedures (Annexes A–H) to align test practice across product standards and to help manufacturers, testing laboratories and purchasers verify instrument resistance to autoclaving, corrosion and thermal stress.

Key topics and requirements

• Scope: Test methods for stainless steel surgical and dental hand instruments to determine resistance to autoclaving, corrosion and thermal exposure.
• Sampling: Manufacturers shall define sampling plans in accordance with ISO 7554-3.
• Test catalogue: Annexes provide specific procedures:
  • Boiling test in deionized water (Annex A, normative) - detects surface defects, free iron or anodic contaminants.
  • Boiling test in 0.9% NaCl (Annex B, informative) - corrosion resistance check for higher-chromium steels.
  • Copper sulfate tests (Annex C normative for ≥16% Cr; Annex D normative for martensitic <16% Cr) - assess material selection, heat treatment and workmanship.
  • Additional informative tests: 0.3% NaCl (Annex E), citric acid solution (Annex F), thermal test (Annex G) and autoclave (sterilization) test (Annex H).
• Evaluation: Visual inspection according to EN 13018 with ×10 magnification; surfaces should show no corrosion without magnification. Specific exceptions (e.g., rust in serrations, brazed joints, laser marks) are allowed.
• Test report: Minimum information includes sample identification, reference to ISO 13402:2025, method used, deviations, dates, laboratory ID and authorized signatures.

Applications and who uses the standard

• Instrument manufacturers: For product development, QC and type-testing to demonstrate corrosion resistance and thermal stability of surgical and dental hand instruments.
• Testing laboratories: To perform standardized boiling, copper sulfate, autoclave and thermal tests and to produce compliant test reports.
• Procurement and regulatory bodies: To specify acceptance testing or contractual test requirements for suppliers.
• Hospitals and sterilization departments: To understand expected performance of instruments under autoclave cycles and to select compliant products.

Keywords: ISO 13402:2025, surgical and dental hand instruments, autoclaving, corrosion resistance, thermal exposure, stainless steel testing, boiling test, copper sulfate test, austenitic, martensitic, ferritic.

Related standards

• ISO 3696 (water quality for tests)
• ISO 7554-3 (sampling and test planning)
• EN 13018 (visual testing principles)
• Relevant product standards referenced for specific instruments (e.g., ISO 7151, ISO 9173-1)