ISO 7151:2024

Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods

This document specifies general requirements and corresponding test methods for a general range of non-cutting instruments in surgery.

Instruments chirurgicaux — Instruments articulés, non tranchants — Spécifications générales et méthodes d'essai

General Information

• Status: Published
• Publication Date: 25-Apr-2024
• ICS: 11.040.30 - Surgical instruments and materials
• Technical Committee: ISO/TC 170 - Surgical instruments
• Drafting Committee: ISO/TC 170 - Surgical instruments
• Current Stage: 6060 - International Standard published
• Start Date: 26-Apr-2024
• Due Date: 02-Sep-2024
• Completion Date: 26-Apr-2024

Relations

• Revises: ISO 7151:1988 - Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
• Effective Date: 06-Jun-2022

Standards Content (Sample)

International
Standard
ISO 7151
Third edition
Surgical instruments — Non-cutting,
2024-04
articulated instruments — General
requirements and test methods
Instruments chirurgicaux — Instruments articulés, non
tranchants — Spécifications générales et méthodes d'essai
Reference number
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
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Published in Switzerland
ii
Contents Page
Foreword .iv
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Material. 1
5 Requirements . 2
5.1 Heat, treatment and hardness for component parts, excluding rivets and screws and
part manufactures of material grade i .2
5.1.1 Heat treatment .2
5.1.2 Hardness of instruments .2
5.1.3 Hardness of tungsten carbide inserts .2
5.2 Corrosion resistance .2
5.2.1 General .2
5.2.2 Test for resistance to copper sulfate .2
5.2.3 Test for resistance to boiling water .2
5.3 Workmanship .2
5.4 Surface condition .3
5.4.1 General .3
5.4.2 Surface finish .3
5.4.3 Passivation and final treatment .3
5.5 Elasticity .3
5.6 Function of needle holders .3
6 Test methods . 3
6.1 Copper sulfate test .3
6.2 Boiling water test .4
6.3 Elasticity test for haemostatic forceps and needle holders .4
6.4 Function test of needle holders.4
7 Marking . . 4

iii
Foreword
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