Implants for surgery — Metallic materials — Part 5: Wrought cobalt-chromium-tungsten-nickel

This document specifies the characteristics of, and corresponding test methods for, wrought cobalt-chromium-tungsten-nickel alloy for use in the manufacture of surgical implants. NOTE The tensile properties of a sample obtained from a finished product made of this alloy do not necessarily comply with those specified in this document.

Implants chirurgicaux — Produits à base de métaux — Partie 5: Alliage corroyé à base de cobalt, de chrome, de tungstène et de nickel

General Information

Status
Published
Publication Date
17-Mar-2022
Technical Committee
Drafting Committee
Current Stage
5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
Start Date
07-Dec-2021
Completion Date
07-Dec-2021
Ref Project

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INTERNATIONAL ISO
STANDARD 5832-5
Fourth edition
2022-03
Implants for surgery — Metallic
materials —
Part 5:
Wrought cobalt-chromium-tungsten-
nickel
Implants chirurgicaux — Produits à base de métaux —
Partie 5: Alliage corroyé à base de cobalt, de chrome, de tungstène et
de nickel
Reference number
ISO 5832-5:2022(E)
© ISO 2022
---------------------- Page: 1 ----------------------
ISO 5832-5:2022(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2022

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 2022 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 5832-5:2022(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 Chemical composition ....................................................................................................................................................................................1

5 Microstructure....................................................................................................................................................................................................... 2

5.1 Grain size index ...................................................................................................................................................................................... 2

5.2 Inclusion content .................................................................................................................................................................................. 2

6 Tensile properties .............................................................................................................................................................................................. 2

7 Test methods ............................................................................................................................................................................................................ 3

iii
© ISO 2022 – All rights reserved
---------------------- Page: 3 ----------------------
ISO 5832-5:2022(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

SC 1, Materials.

This fourth edition cancels and replaces the third edition (ISO 5832-5:2005) which has been technically

revised. The main changes are as follows:
— the introduction has been updated;
— limits for carbon, silicon, and manganese in Table 1 have been updated;
— requirements of inclusion content in Table 2 have been updated;
— tensile properties Clause 6 and Table 3 have b
...

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 5832-5
ISO/TC 150/SC 1
Implants for surgery — Metallic
Secretariat: DIN
materials —
Voting begins on:
2021-12-07
Part 5:
Voting terminates on:
Wrought cobalt-chromium-tungsten-
2022-02-01
nickel
Implants chirurgicaux — Produits à base de métaux —
Partie 5: Alliage corroyé à base de cobalt, de chrome, de tungstène et
de nickel
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
Reference number
BEING ACCEPTABLE FOR INDUSTRIAL, TECHNO-
ISO/FDIS 5832-5:2021(E)
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. © ISO 2021
---------------------- Page: 1 ----------------------
ISO/FDIS 5832-5:2021(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2021

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 2021 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/FDIS 5832-5:2021(E)
Contents Page

Foreword ........................................................................................................................................................................................................................................iv

Introduction .................................................................................................................................................................................................................................v

1 Scope ................................................................................................................................................................................................................................. 1

2 Normative references ..................................................................................................................................................................................... 1

3 Terms and definitions .................................................................................................................................................................................... 1

4 Chemical composition ....................................................................................................................................................................................1

5 Microstructure....................................................................................................................................................................................................... 2

5.1 Grain size index ...................................................................................................................................................................................... 2

5.2 Inclusion content .................................................................................................................................................................................. 2

6 Tensile properties .............................................................................................................................................................................................. 2

7 Test methods ............................................................................................................................................................................................................ 3

iii
© ISO 2021 – All rights reserved
---------------------- Page: 3 ----------------------
ISO/FDIS 5832-5:2021(E)
Foreword

ISO (the International Organization for Standardization) is a worldwide federation of national standards

bodies (ISO member bodies). The work of preparing International Standards is normally carried out

through ISO technical committees. Each member body interested in a subject for which a technical

committee has been established has the right to be represented on that committee. International

organizations, governmental and non-governmental, in liaison with ISO, also take part in the work.

ISO collaborates closely with the International Electrotechnical Commission (IEC) on all matters of

electrotechnical standardization.

The procedures used to develop this document and those intended for its further maintenance are

described in the ISO/IEC Directives, Part 1. In particular, the different approval criteria needed for the

different types of ISO documents should be noted. This document was drafted in accordance with the

editorial rules of the ISO/IEC Directives, Part 2 (see www.iso.org/directives).

Attention is drawn to the possibility that some of the elements of this document may be the subject of

patent rights. ISO shall not be held responsible for identifying any or all such patent rights. Details of

any patent rights identified during the development of the document will be in the Introduction and/or

on the ISO list of patent declarations received (see www.iso.org/patents).

Any trade name used in this document is information given for the convenience of users and does not

constitute an endorsement.

For an explanation of the voluntary nature of standards, the meaning of ISO specific terms and

expressions related to conformity assessment, as well as information about ISO's adherence to

the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT), see

www.iso.org/iso/foreword.html.

This document was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee

SC 1 Materials.

This fourth edition cancels and replaces the third edition (ISO 5832-5:2005) which has been te

...

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