ISO 13402-2025 PDF

Full title and description

ISO 13402:2025 — Surgical and dental hand instruments — Determination of resistance against autoclaving, corrosion and thermal exposure. This international standard specifies test methods for evaluating the resistance of stainless-steel surgical and dental hand instruments to repeated autoclaving cycles, corrosive attack and thermal exposure that can occur during routine processing and use.

Abstract

The document describes standardized test procedures to assess how stainless-steel surgical and dental hand instruments withstand sterilization in autoclaves, exposure to corrosive conditions and elevated temperatures. It defines specimen preparation, conditioning, test execution and reporting so manufacturers, test laboratories and conformity assessment bodies can evaluate instrument durability and identify materials or treatments that impair long-term performance.

General information

• Status: Published
• Publication date: 7 March 2025
• Publisher: International Organization for Standardization (ISO)
• ICS / categories: 11.040.30; 11.060.20
• Edition / version: Edition 2 (2025)
• Number of pages: 18

Key bibliographic facts above are taken from the ISO publication record and national-catalogue entries for ISO 13402:2025.

Scope

ISO 13402:2025 applies to stainless-steel hand-held surgical and dental instruments and specifies test methods to determine their resistance to autoclaving, to corrosive attack and to thermal exposure. The scope covers specimen selection and preparation, test cycles/conditions representative of reprocessing and use, inspection and evaluation criteria, and the format for reporting results. This edition replaces ISO 13402:1995.

Key topics and requirements

• Standardized autoclave cycling procedures to simulate repeated sterilization and identify physical or surface degradation.
• Corrosion-resistance tests and visual/functional inspection methods to detect pitting, staining or loss of passivation.
• Thermal exposure tests to assess dimensional stability and loss of mechanical properties after heat treatment or accidental overheating.
• Specimen selection, preparation and conditioning rules to ensure reproducible results.
• Acceptance, reporting and documentation requirements so manufacturers and test laboratories can demonstrate conformity and compare results.

The topics above summarize the principal requirements and test categories defined in the standard.

Typical use and users

Primary users include manufacturers of surgical and dental hand instruments, independent test and certification laboratories, quality and regulatory affairs teams, procurement specialists assessing supplier claims, and hospital sterile-processing departments interested in instrument lifecycle and reprocessing performance. Regulators and conformity assessment bodies may also reference the standard when evaluating product claims.

Related standards

Related and complementary standards include the withdrawn ISO 13402:1995 (superseded by this edition), standards on processing/sterilization information such as the ISO 17664 series (information to be provided by the manufacturer for processing/sterilization of medical devices), and broader medical-device sector standards (for example, quality management ISO 13485). Regional adoptions (EN ISO / national editions) align this standard with local regulatory and procurement practices.

Keywords

autoclave; sterilization cycles; corrosion resistance; thermal exposure; surgical instruments; dental instruments; stainless steel; test methods; ISO 13402; instrument durability

FAQ

Q: What is this standard?

A: ISO 13402:2025 is an international standard specifying test methods to determine the resistance of stainless-steel surgical and dental hand instruments to autoclaving, corrosion and thermal exposure.

Q: What does it cover?

A: It covers specimen selection and preparation, defined autoclave and exposure tests, inspection and evaluation criteria, and reporting requirements so manufacturers and test laboratories can assess instrument durability under reprocessing and use conditions.

Q: Who typically uses it?

A: Manufacturers, test and certification laboratories, hospital sterile-processing staff, procurement and regulatory teams, and conformity assessment bodies.

Q: Is it current or superseded?

A: Current — ISO 13402:2025 (Edition 2) is published (7 March 2025) and supersedes ISO 13402:1995.

Q: Is it part of a series?

A: It is maintained under ISO/TC 170 (surgical instruments) and is related to standards addressing sterilization and processing information (for example the ISO 17664 series) and wider medical-device requirements such as ISO 13485. It is often adopted regionally as EN ISO or national identical standards.

Q: What are the key keywords?

A: Autoclave, corrosion resistance, thermal exposure, surgical instruments, dental instruments, stainless steel, test methods, durability, ISO 13402.