ISO 13402:2025 PDF

Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure

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Title (English):

ISO 13402:2025

Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure

Document status:: Active
Format:: Electronic (PDF)
Number of pages:: 18
Publication date:: March 7, 2025
Edition:: ISO IS 13402 edition 2 version 1
ICS:: 11.040.30

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Description (English):

This document describes test methods to determine the resistance of stainless steel surgical and dental hand instruments against autoclaving, corrosion and thermal exposure.

Technical details

Technical committee: ISO/TC 170 - Surgical instruments
SKU: ISO 13402:2025

Abstract

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

Related standards

Mentioned in the description and other ISO standards

Overview

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

ISO 13402:2025 PDF

Technical details

Abstract

Overview

Key topics and requirements

Related standards

Abstract

Overview

Key topics and requirements

Related standards

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