ISO 7151:2024
(Main)Surgical instruments — Non-cutting, articulated instruments — General requirements and test methods
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
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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 7151:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
ISO 7151:2024(en)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO 7151:2024(en)
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 .
...
FINAL DRAFT
International
Standard
ISO/FDIS 7151
ISO/TC 170
Surgical instruments — Non-
Secretariat: DIN
cutting, articulated instruments
Voting begins on:
— General requirements and test
2024-02-02
methods
Voting terminates on:
2024-03-29
Instruments chirurgicaux — Instruments articulés, non
tranchants — Spécifications générales et méthodes d'essai
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
IN ADDITION TO THEIR EVALUATION AS
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
Reference number
ISO/FDIS 7151:2024(en) © ISO 2024
---------------------- Page: 1 ----------------------
FINAL DRAFT
ISO/FDIS 7151:2024(en)
International
Standard
ISO/FDIS 7151
ISO/TC 170
Surgical instruments — Non-
Secretariat: DIN
cutting, articulated instruments
Voting begins on:
— General requirements and test
methods
Voting terminates on:
Instruments chirurgicaux — Instruments articulés, non
tranchants — Spécifications générales et méthodes d'essai
RECIPIENTS OF THIS DRAFT ARE INVITED TO SUBMIT,
COPYRIGHT PROTECTED DOCUMENT
WITH THEIR COMMENTS, NOTIFICATION OF ANY
RELEVANT PATENT RIGHTS OF WHICH THEY ARE AWARE
AND TO PROVIDE SUPPOR TING DOCUMENTATION.
© ISO 2024
IN ADDITION TO THEIR EVALUATION AS
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO
LOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying, or posting on
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE
the internet or an intranet, without prior written permission. Permission can be requested from either ISO at the address below
TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL
or ISO’s member body in the country of the requester.
TO BECOME STAN DARDS TO WHICH REFERENCE MAY BE
MADE IN NATIONAL REGULATIONS.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: +41 22 749 01 11
Email: copyright@iso.org
Website: www.iso.org
Published in Switzerland Reference number
ISO/FDIS 7151:2024(en) © ISO 2024
© ISO 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 7151:2024(en)
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 .
...
ISO/FDIS 7151:2023(E)
ISO/TC 170
Secretariat: DIN
Date: 2023-12-152024-01-18
Surgical instruments — Non-cutting, articulated instruments —
General requirements and test methods
Instruments chirurgicaux — Instruments articulés, non tranchants — Spécifications générales et méthodes
d'essai
FDIS stage
© ISO 2023 – All rights reserved
---------------------- Page: 1 ----------------------
ISO/FDIS 7151:2024(Een)
© ISO 2024
All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication
may be reproduced or utilized otherwise in any form or by any means, electronic or mechanical, including photocopying,
or posting on the internet or an intranet, without prior written permission. Permission can be requested from either ISO
at the address below or ISO’s member body in the country of the requester.
ISO copyright office
CP 401 • Ch. de Blandonnet 8
CH-1214 Vernier, Geneva
Phone: + 41 22 749 01 11
EmailE-mail: copyright@iso.org
Website: www.iso.orgwww.iso.org
Published in Switzerland
© ISO 2023 2024 – All rights reserved
ii
---------------------- Page: 2 ----------------------
ISO/FDIS 7151:2023(E2024(en)
Contents
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 Elastici
...
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