ISO 12891-2:2014
(Main)Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved surgical implants
ISO 12891-2:2014 specifies methods for the analysis of retrieved surgical implants. ISO 12891-2:2014 describes the analysis of retrieved metallic, polymeric and ceramic implants. The analysis is divided into three stages which are increasingly destructive. ISO 12891-2:2014 can also be applied to other materials, e.g. animal tissue implants. ISO 12891-2:2014 can be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues and associated biological material.
Retrait et analyse des implants chirurgicaux — Partie 2: Analyse des implants chirurgicaux métalliques retirés
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INTERNATIONAL ISO
STANDARD 12891-2
Second edition
2014-09-15
Retrieval and analysis of surgical
implants —
Part 2:
Analysis of retrieved surgical implants
Retrait et analyse des implants chirurgicaux —
Partie 2: Analyse des implants chirurgicaux métalliques retirés
Reference number
©
ISO 2014
© ISO 2014
All rights reserved. Unless otherwise specified, 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
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Published in Switzerland
ii © ISO 2014 – All rights reserved
Contents Page
Foreword .iv
Introduction .v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Procedures for retrieval, handling and packaging . 1
5 Analysis of the implant interfaces . 2
5.1 Implant/tissue interface . 2
5.2 Implant/implant interfaces. 2
6 Analysis of the implant . 2
6.1 General . 2
6.2 Forms for recording the results of the analyses . 3
6.3 Stage I investigation (macroscopic examination — non-destructive) . 3
6.4 Stage II investigation (microscopic examination — mostly non-destructive) . 3
6.5 Stage III investigation (material investigation — mostly destructive) . 4
6.6 Surface-treated or coated implants . 6
6.7 Biodegradable implants . 6
7 Implant performance . 7
Annex A (normative) Standard forms for the analysis of retrieved surgical implants .8
Annex B (informative) ISO Standards applicable for the evaluation of materials .22
Bibliography .26
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 on the meaning of ISO specific terms and expressions related to conformity
assessment, as well as information about ISO’s adherence to the WTO principles in the Technical Barriers
to Trade (TBT) see the following URL: Foreword - Supplementary information
The committee responsible for this document is ISO/TC 150, Implants for surgery.
This second edition cancels and replaces the first editions (ISO 12891-2:2000, ISO 12891-3:2000,
ISO 12891-4:2000), which have been merged and technically revised.
ISO 12891 consists of the following parts, under the general title Retrieval and analysis of surgical
implants:
— Part 1: Retrieval and handling
— Part 2: Analysis of retrieved surgical implants
iv © ISO 2014 – All rights reserved
Introduction
The investigation of retrieved implantable medical devices and adjacent tissues can be of diagnostic
value in the event of clinical complications, can deepen our knowledge of clinical implant performance
and safety, and can improve our understanding of the interactions between implants and the body, thus,
furthering the development of implants with improved biocompatibility and functional longevity.
This part of ISO 12891 specifies methods for the retrieval, handling, and analysis of surgical implants
and associated specimens which are retrieved from patients during revision surgery or post-mortem.
The aim is to provide guidance in preventing damage to the specimens which could obscure the
investigation results, and in gathering data at the proper time and under the proper circumstances.
ISO 12891-1 deals with retrieval and handling. This part of ISO 12891 concerns the analysis of implants
of specific materials, and includes protocols for reporting the data collected. For particular investigation
programmes, additional, more specific protocols can be required. If special analytical techniques are
employed, the procedures used should be specified.
This part of ISO 12891 specifies methods for the analysis of retrieved surgical implants to ensure
they are not damaged, to indicate typical investigation techniques, and to allow comparisons between
investigation results from different sources. These methods may be useful for retrieval and analysis
studies in animals.
This part of ISO 12891 provides for a thorough examination of all aspects of an explanted prosthesis.
In many cases only a subset of these examinations will be appropriate to the investigation of a specific
explanted device.
ISO 12891-1 specifies methods for retrieval and handling and applies to this part of ISO 12891. Annexes A
and C of ISO 12891-1 include examples of protocols for reporting data concerning the retrieval process.
These protocols are not repeated in this part of ISO 12891. They may be reduced or expanded depending
on the retrieved surgical implant, the presence of any attached or accompanying biological material, and
the purpose of the retrieval and analysis.
INTERNATIONAL STANDARD ISO 12891-2:2014(E)
Retrieval and analysis of surgical implants —
Part 2:
Analysis of retrieved surgical implants
1 Scope
This part of ISO 12891 specifies methods for the analysis of retrieved surgical implants.
This part of ISO 12891 describes the analysis of retrieved metallic, polymeric and ceramic implants. The
analysis is divided into three stages which are increasingly destructive.
This part of ISO 12891 can also be applied to other materials, e.g. animal tissue implants.
This part of ISO 12891 can be applied in accordance with national regulations or legal requirements
regarding the handling and analysis of retrieved implants and tissues and associated biological material.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated
references, the latest edition of the referenced document (including any amendments) applies.
ISO 12891-1:2011, Implants for surgery — Retrieval and analysis of surgical implants — Part 1: Retrieval
and handling
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
surgical implant
implant
medical device intended to be inserted into the body by surgical techniques
Note 1 to entry: The medical device is hereafter referred to as an “implant”.
Note 2 to entry: The implant can be a component of a modular or multicomponent implant.
4 Procedures for retrieval, handling and packaging
Procedures for retrieval, handling, packaging, and protection of the personnel involved shall be in
accordance with ISO 12891-1.
As a precautionary measure, retrieved implants shall be decontaminated by an appropriate means that
does not adversely affect the implant or the planned investigation. Appropriate methods are given in 3.8
of ISO 12891-1:2011.
Any difficulty in the implant retrieval procedure leading to unavoidable implant damage during it shall
be reported together with a description of the produced damage.
Cleaning solutions (see ISO 12891-1:2011, Table 1) can interact with the material, e.g. corrosion or
dissolution and should be chosen to minimize this risk.
Photographic records of the surgical field should be made before the implant retrieval, if appropriate.
5 Analysis of the implant interfaces
5.1 Implant/tissue interface
A significant part of the information associated with a retrieved surgical implant is often at the
implant/tissue interface. Attention shall be given to the interface and to the peri-implant tissue and its
contents. Where required, analyses of the chemistry and nature of the byproducts of degradation of the
implant and a study of the cellular response to the implant shall be considered.
In cases where implant surfaces are designed to promote tissue ingrowth or ongrowth, a study of the
implant tissue interface can be of particular interest, and the findings shall be recorded. If residues are
adherent to the surface of the implant, this shall be recorded.
Since the appearance of the tissue can vary significantly with the distance from the implant surface, it
is important that the tissue is analysed in its context with the implant. Where possible, tissue, fluid, and
particulate samples should be collected for further analysis (see ISO 12891-1, 3.4).
5.2 Implant/implant interfaces
Where implants articulate on or are in contact with other implant components, the condition of the
contacting surface areas of the implant can be of particular interest. Their study shall be considered in
the context of the opposing surfaces.
In addition to studying the condition of contacting surfaces, the surrounding area shall also be studied
to determine whether wear debris is present.
6 Analysis of the implant
6.1 General
This clause describes the different degrees of characterization to be considered when a retrieved
implant is under investigation.
The analyses of the retrieved implant are divided into three stages, with the degree of characterization
and destruction increasing from stage I to stage III. The implant characterizations can include
macroscopic and microscopic examinations, chemical analyses, and the determination of physical and
mechanical properties.
Because of the complexity of the materials that can be used for implants, and because of the large number
of potential analyses and tests suggested in this part of ISO 12891, the stage and type of analysis to be
performed shall be chosen as a function of the type of implant and the purpose of the investigation.
The examinations selected to be performed shall depend upon the reason for removal and examination
of the implant, and possible restrictions in destructive testing. Perform a minimum number of
investigations for routine removals where the implant is not suspected to have malfunctioned, more
examinations for implants suspected of having a functional impairment, and extensive investigations
for implants retrieved because of
...
DRAFT INTERNATIONAL STANDARD ISO/DIS 12891-2
ISO/TC 150 Secretariat: DIN
Voting begins on Voting terminates on
2013-02-14 2013-05-14
INTERNATIONAL ORGANIZATION FOR STANDARDIZATION • МЕЖДУНАРОДНАЯ ОРГАНИЗАЦИЯ ПО СТАНДАРТИЗАЦИИ • ORGANISATION INTERNATIONALE DE NORMALISATION
Retrieval and analysis of surgical implants —
Part 2:
Analysis of retrieved surgical implants
Retrait et analyse des implants chirurgicaux —
Partie 2: Analyse des implants chirurgicaux métalliques retirés
[Revision of first edition (ISO 12891-2:2000)]
ICS 11.040.40
To expedite distribution, this document is circulated as received from the committee
secretariat. ISO Central Secretariat work of editing and text composition will be undertaken at
publication stage.
Pour accélérer la distribution, le présent document est distribué tel qu'il est parvenu du
secrétariat du comité. Le travail de rédaction et de composition de texte sera effectué au
Secrétariat central de l'ISO au stade de publication.
THIS DOCUMENT IS A DRAFT CIRCULATED FOR COMMENT AND APPROVAL. IT IS THEREFORE SUBJECT TO CHANGE AND MAY NOT BE
REFERRED TO AS AN INTERNATIONAL STANDARD UNTIL PUBLISHED AS SUCH.
IN ADDITION TO THEIR EVALUATION AS BEING ACCEPTABLE FOR INDUSTRIAL, TECHNOLOGICAL, COMMERCIAL AND USER PURPOSES, DRAFT
INTERNATIONAL STANDARDS MAY ON OCCASION HAVE TO BE CONSIDERED IN THE LIGHT OF THEIR POTENTIAL TO BECOME STANDARDS TO
WHICH REFERENCE MAY BE MADE IN NATIONAL REGULATIONS.
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 SUPPORTING DOCUMENTATION.
© International Organization for Standardization, 2013
ISO/DIS 12891-2
Copyright notice
This ISO document is a Draft International Standard and is copyright-protected by ISO. Except as permitted
under the applicable laws of the user’s country, neither this ISO draft nor any extract from it may be
reproduced, stored in a retrieval system or transmitted in any form or by any means, electronic,
photocopying, recording or otherwise, without prior written permission being secured.
Requests for permission to reproduce should be addressed to either ISO at the address below or ISO’s
member body in the country of the requester.
ISO copyright office
Case postale 56 • CH-1211 Geneva 20
Tel. + 41 22 749 01 11
Fax + 41 22 749 09 47
E-mail copyright@iso.org
Web www.iso.org
Reproduction may be subject to royalty payments or a licensing agreement.
Violators may be prosecuted.
ii © ISO 2013 – All rights reserved
ISO/DIS 12891-2
Contents Page
Foreword . iv
Introduction . v
1 Scope . 1
2 Normative references . 1
3 Terms and definitions . 1
4 Procedures for retrieval, handling and packaging . 1
5 Analysis of the implant interfaces . 2
5.1 Implant/tissue interface . 2
5.2 Implant/implant interfaces . 2
6 Analysis of the implant . 2
6.1 General . 2
6.2 Forms for recording the results of the analyses . 2
6.3 Stage I investigation (macroscopic examination — non-destructive) . 3
6.3.1 Identification/photography . 3
6.3.2 Visual examination . 3
6.3.3 Low-power optical examination . 3
6.3.4 Further evaluation . 3
6.4 Stage II investigation (microscopic examination — mostly non-destructive) . 3
6.4.1 General . 3
6.4.2 Microscopic examination. 3
6.4.3 Fractographic examination. 3
6.4.4 Surface topography . 4
6.5 Stage III investigation (material investigation — mostly destructive) . 4
6.5.1 General . 4
6.5.2 Material composition . 4
6.5.3 Microstructure . 5
6.5.4 Mechanical properties . 5
6.6 Surface-treated or coated implants . 6
6.7 Biodegradable implants . 6
7 Implant performance . 6
Annex A (normative) Standard forms for the analysis of retrieved surgical implants . 7
A.1 General . 7
A.2 Form for examination of retrieved metallic surgical implant . 8
A.3 Form for examination of retrieved polymeric surgical implant . 11
A.4 Form for examination of retrieved ceramic surgical implant . 15
Annex B (informative) Applicable International Standards for the evaluation of materials . 18
B.1 Metallic materials . 18
B.1.1 Chemical, microstructural and mechanical properties . 18
B.1.2 Microstructural testing . 18
B.1.3 Mechanical testing . 18
B.2 Polymeric materials . 19
B.2.1 Chemical, physicochemical, thermal and mechanical properties . 19
B.2.2 Physicochemical testing. 19
B.2.3 Mechanical testing . 20
B.3 Ceramic materials . 20
B.3.1 Chemical, microstructural and mechanical properties . 20
B.3.2 Physical testing . 21
B.3.3 Mechanical testing . 21
Bibliography . 22
ISO/DIS 12891-2
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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 2.
The main task of technical committees is to prepare International Standards. Draft International Standards
adopted by the technical committees are circulated to the member bodies for voting. Publication as an
International Standard requires approval by at least 75 % of the member bodies casting a vote.
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.
ISO 12891-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery, Subcommittee SC , .
This second edition cancels and replaces the first editions (ISO 12891-2:2000, ISO 12891-3:2000,
ISO 12891-4:2000), which have been merged and technically revised.
ISO 12891 consists of the following parts, under the general title Implants for surgery — Retrieval and
analysis of surgical implants:
Part 1: Retrieval and handling
Part 2: Analysis of retrieved surgical implants
iv © ISO 2012 – All rights reserved
ISO/DIS 12891-2
Introduction
The investigation of retrieved implantable medical devices and adjacent tissues can be of diagnostic value in
the event of clinical complications, can deepen our knowledge of clinical implant performance and safety and
can improve our understanding of the interactions between implants and the body, thus furthering the
development of implants with improved biocompatibility and functional longevity.
This part of ISO 12891 specifies methods for the retrieval, handling and analysis of surgical implants and
associated specimens which are retrieved from patients, during revision surgery or post-mortem. The aim is to
provide guidance in preventing damage to the specimens which could obscure the investigation results, and in
gathering data at the proper time and under the proper circumstances. Part 1 deals with retrieval and
handling. This part of ISO 12891 concerns the analysis of implants of specific materials, and includes
protocols for reporting the data collected. For particular investigation programmes, additional, more specific,
protocols can be required. If special analytical techniques are employed, the procedures used should be
specified.
This part of ISO 12891 specifies methods for the analysis of retrieved surgical implants to ensure they are not
damaged, to indicate typical investigation techniques, and to allow comparisons between investigation results
from different sources. These methods may be useful for retrieval and analysis studies in animals.
ISO 12891-1 specifies methods for retrieval and handling and applies to this part of ISO 12891. Annex A and
C of ISO 12891-1 include examples of protocols for reporting data concerning the retrieval process. These
protocols are not repeated in this part of ISO 12891. They may be reduced or expanded depending on the
retrieved surgical implant, the presence of any attached or accompanying biological material, and the purpose
of the retrieval and analysis.
DRAFT INTERNATIONAL STANDARD ISO/DIS 12891-2
Retrieval and analysis of surgical implants —
Part 2:
Analysis of retrieved surgical implants
1 Scope
This part of ISO 12891 specifies methods for the analysis of retrieved surgical implants.
This part of ISO 12891 describes the analysis of retrieved metallic, polymeric and ceramic implants. The
analysis is divided into 3 stages which are increasingly destructive.
This part of ISO 12891 can also be applied to other materials, e.g. animal tissue implants.
This part of ISO 12891 can be applied in accordance with national regulations or legal requirements regarding
the handling and analysis of retrieved implants and tissues and associated biological material.
2 Normative references
The following documents, in whole or in part, are normatively referenced in this document and are
indispensable for its application. For dated references, only the edition cited applies. For undated refer
...
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