ISO/FDIS 13179-1

Implants for surgery -- Coatings on metallic surgical implants

Implants chirurgicaux -- Revêtements des implants chirurgicaux métalliques

General Information

• Status: Published
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: ISO/TC 150 - Implants for surgery
• Drafting Committee: ISO/TC 150/WG 12 - Implant coatings
• Current Stage: 5020 - FDIS ballot initiated: 2 months. Proof sent to secretariat
• Start Date: 05-Jul-2021
• Completion Date: 05-Jul-2021

RELATIONS

• Revised: ISO 13179-1:2014 - Implants for surgery -- Plasma-sprayed unalloyed titanium coatings on metallic surgical implants
• Effective Date: 23-Apr-2020

Standards Content (sample)

FINAL
INTERNATIONAL ISO/FDIS
DRAFT
STANDARD 13179-1
ISO/TC 150
Implants for surgery — Coatings on
Secretariat: DIN
metallic surgical implants —
Voting begins on:
2021-07-05
Part 1:
Voting terminates on:
Plasma-sprayed coatings derived from
2021-08-30
titanium or titanium-6 aluminum-4
vanadium alloy powders
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 13179-1:2021(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
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ISO/FDIS 13179-1:2021(E)
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© ISO 2021

All rights reserved. Unless otherwise specified, or required in the context of its implementation, no part of this publication may

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ii © ISO 2021 – All rights reserved
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ISO/FDIS 13179-1:2021(E)
Contents Page

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

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

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

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

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

4 Requirements .......................................................................................................................................................................................................... 2

4.1 Powder for plasma spraying........................................................................................................................................................ 2

4.2 Chemical analysis .................................................................................................................................................................................. 2

4.2.1 Chemical composition ................................................................................................................................................. 2

4.2.2 Sampling.................................................................................................................................................................................. 3

4.2.3 Chemical analysis procedure ................................................................................................................................. 3

4.3 Morphology and microstructure ............................................................................................................................................. 4

4.4 Coating mechanical properties ................................................................................................................................................. 4

4.4.1 General...................................................................................................................................................................................... 4

4.4.2 Static shear strength ..................................................................................................................................................... 4

4.4.3 Shear fatigue strength ................................................................................................................................................. 4

4.4.4 Static tensile strength .................................................................................................................................................. 4

4.4.5 Abrasion resistance ....................................................................................................................................................... 5

4.5 Applicable verifications ................................................................................................................................................................... 5

4.6 Significance of numerical limits ............................................................................................................................................... 5

5 Test report ................................................................................................................................................................................................................... 5

Bibliography ................................................................................................................................................................................................................................ 6

© ISO 2021 – All rights reserved iii
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ISO/FDIS 13179-1:2021(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.

This second edition cancels and replaces the first edition (ISO 13179-1:2014), which has been technically

revised.
The main changes compared to the previous edition are as follows:

— the title and scope of the document were changed to include coatings derived from titanium-6

aluminum-4 vanadium alloy powder;

— two new terms 3.2 and 3.3 were introduced to add a distinction between vacuum plasma spraying

and atmospheric plasma spraying;

— in 4.2.1, three separate tables were introduced to distinguish the chemical composition limits of

different coating addressed by this document;

— in 4.4.3, the term shear fatigue maximum strain was corrected to shear fatigue maximum stress.

A list of all parts in the ISO 13179-1 series can be found on the ISO website.

Any feedback or questions on this document should be directed to the user’s national standards body. A

complete listing of these bodies can be found at www .iso .org/ members .html.
iv © ISO 2021 – All rights reserved
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ISO/FDIS 13179-1:2021(E)
Introduction

While no known surgical implant material has ever been shown to be completely free of adverse

reactions in the human body, long term clinical experience with the material referred to in this

document has shown that an acceptable level of biological response can be expected, if the material is

used in appropriate applications. However, this document covers the raw material, coating structures

and properties and not finished medical devices, where the design and fabrication of the device can

also impact biological response.
© ISO 2021 – All rights reserved v
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FINAL DRAFT INTERNATIONAL STANDARD ISO/FDIS 13179-1:2021(E)
Implants for surgery — Coatings on metallic surgical
implants —
Part 1:
Plasma-sprayed coatings derived from titanium or
titanium-6 aluminum-4 vanadium alloy powders
1 Scope

This document specifies general requirements for plasma-sprayed titanium coatings on metallic

surgical implants.
This document applies to atmospheric plasma spraying and vacuum plasma spraying.

This document does not apply to coatings made of other materials than titanium or titanium-6

aluminum-4 vanadium alloy or to coatings realized by another technology than plasma spraying.

NOTE A quality management system can be useful, e.g. as described in ISO 13485. Requirements for the

competence of testing laboratories can be found in ISO/IEC 17025.
2 Normative references

The following documents are referred to in the text in such a way that some or all of their content

constitutes requirements of this document. For dated references, only the edition cited applies. For

undated references, the latest edition of the referenced document (including any amendments) applies.

ISO 4288, Geometrical Product Specifications (GPS) — Surface texture: Profile method — Rules and

procedures for the assessment of surface texture
ASTM F1044, Standard Test Method for Shear Testing of Calcium Phospha
...