ISO 13402:2025 PDF

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

Название (английский):

ISO 13402:2025

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 18
Дата публикации:: 7 марта 2025 г.
Издание:: ISO IS 13402 edition 2 version 1
ICS:: 11.040.30

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Описание (английский):

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

Технические детали

Технический комитет: 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

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

Технические детали

Abstract

Overview

Key topics and requirements

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Abstract

Overview

Key topics and requirements

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