ISO/TS 20721:2020
(Main)Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants
Implants for surgery — General guidelines and requirements for assessment of absorbable metallic implants
This document established the currently recognized approaches and special considerations needed when evaluating the in vitro and in vivo performance of absorbable metals and implants fabricated, in whole or in part, from them. This document describes how the evaluation of these metals can differ from those utilized for permanent non-absorbable implantable implants (or subcomponents), in that absorbable metal implants (or subcomponents) are — by design — intended to be absorbed in their entirety by the host. This document provides guidance regarding the materials considerations, in vitro degradation/fatigue characterization, and biological evaluation of medical implants made of absorbable metals. The provided content is intended to deliver added clarity to the evaluation of these materials and implants to increase awareness of critical factors and reduce potential for generation of erroneous or misleading test results. While this document and the herein described referenced standards contain many suggested alterations or modifications to currently practiced procedures or specifications, the provided content is intended to complement, and not replace, current conventions regarding the assessment of implantable implants. This document covers the evaluation of absorbable metal specific attributes in general and is not intended to cover application or implant specific considerations. Thus, it is important to consult relevant implant and/or application specific standards. This document does not apply to non-absorbable or non-metallic components (e.g. polymeric coatings, pharmaceuticals, non-absorbable metals) used in conjunction with absorbable metal implants.
Implants chirurgicaux — Lignes directrices et exigences générales pour l'évaluation des implants métalliques absorbables
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TECHNICAL ISO/TS
SPECIFICATION 20721
First edition
2020-09
Implants for surgery — General
guidelines and requirements for
assessment of absorbable metallic
implants
Reference number
ISO/TS 20721:2020(E)
©
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 20721:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
ii © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 20721:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Absorbable metal considerations . 2
4.1 General . 2
4.2 Design considerations. 3
4.2.1 Composition . 3
4.2.2 Coatings . 4
4.2.3 Non-absorbable subcomponents . 4
4.2.4 Microstructure . 4
4.2.5 Implant design and functional performance . 5
4.3 The absorption process . 5
4.3.1 General outline . 5
4.3.2 Metallic conversion . 5
4.3.3 Subsequent degradation reactions . 6
4.3.4 Elemental impact on absorption . 6
4.3.5 Biological absorption . 6
4.3.6 Mechanical loss . 6
5 Metallurgical and manufacturing considerations .
...
TECHNICAL ISO/TS
SPECIFICATION 20721
First edition
Implants for surgery — Standard
guide to assessment of absorbable
metallic implants
Implants chirurgicaux — Guide général pour l’évaluation des
implants métalliques absorbables
PROOF/ÉPREUVE
Reference number
ISO/TS 20721:2020(E)
©
ISO 2020
---------------------- Page: 1 ----------------------
ISO/TS 20721:2020(E)
COPYRIGHT PROTECTED DOCUMENT
© ISO 2020
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
ii PROOF/ÉPREUVE © ISO 2020 – All rights reserved
---------------------- Page: 2 ----------------------
ISO/TS 20721:2020(E)
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Absorbable metal considerations . 2
4.1 General . 2
4.2 Design considerations. 3
4.2.1 Composition . 3
4.2.2 Coatings . 4
4.2.3 Non-absorbable subcomponents . 4
4.2.4 Microstructure . 4
4.2.5 Implant design and functional performance . 5
4.3 The absorption process . 5
4.3.1 General outline . 5
4.3.2 Metallic conversion . 5
4.3.3 Subsequent degradation reactions . 6
4.3.4 Elemental impact on absorption . 6
4.3.5 Biological absorption . 6
4.3.6 Mechanical loss .
...
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