ISO 12891-2:2000
(Main)Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved metallic surgical implants
Retrieval and analysis of surgical implants — Part 2: Analysis of retrieved metallic surgical implants
Retrait et analyse des implants chirurgicaux — Partie 2: Analyse des implants chirurgicaux métalliques retirés
General Information
Relations
Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 12891-2
First edition
2000-02-15
Retrieval and analysis of surgical
implants —
Part 2:
Analysis of retrieved metallic surgical
implants
Retrait et analyse des implants chirurgicaux —
Partie 2: Analyse des implants chirurgicaux métalliques retirés
Reference number
ISO 12891-2:2000(E)
©
ISO 2000
---------------------- Page: 1 ----------------------
ISO 12891-2:2000(E)
PDF disclaimer
This PDF file may contain embedded typefaces. In accordance with Adobe's licensing policy, this file may be printed or viewed but shall not
be edited unless the typefaces which are embedded are licensed to and installed on the computer performing the editing. In downloading this
file, parties accept therein the responsibility of not infringing Adobe's licensing policy. The ISO Central Secretariat accepts no liability in this
area.
Adobe is a trademark of Adobe Systems Incorporated.
Details of the software products used to create this PDF file can be found in the General Info relative to the file; the PDF-creation parameters
were optimized for printing. Every care has been taken to ensure that the file is suitable for use by ISO member bodies. In the unlikely event
that a problem relating to it is found, please inform the Central Secretariat at the address given below.
© ISO 2000
All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized in any form or by any means, electronic
or mechanical, including photocopying and microfilm, without permission in writing from 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 22 734 10 79
E-mail copyright@iso.ch
Web www.iso.ch
Printed in Switzerland
ii © ISO 2000 – All rights reserved
---------------------- Page: 2 ----------------------
ISO 12891-2:2000(E)
Contents Page
Foreword.iv
Introduction.v
1 Scope .1
2 Normative reference .1
3 Term and definition .1
4 Procedures for retrieval, handling and packaging.1
5 Analysis of the tissue/implant interface.2
6 Analysis of the implant .2
6.1 General.2
6.2 Standard forms .2
6.3 Stage I investigation — Macroscopic examination (non-destructive).2
6.4 Stage II investigation — Microscopic examination (mostly non-destructive) .3
6.5 Stage III investigation — Material investigation (mostly destructive).3
6.6 Provisions for coated implants .4
7 Implant performance .4
Annex A (informative) Standard form for guiding the analysis of retrieved metallic surgical implants.5
Annex B (informative) Referee methods for the evaluation of metallic materials.8
© ISO 2000 – All rights reserved iii
---------------------- Page: 3 ----------------------
ISO 12891-2:2000(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.
International Standards are drafted in accordance with the rules given in the ISO/IEC Directives, Part 3.
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 part of ISO 12891 may be the subject of
patent rights. ISO shall not be held responsible for identifying any or all such patent rights.
International Standard ISO 12891-2 was prepared by Technical Committee ISO/TC 150, Implants for surgery.
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 metallic surgical implants
� Part 3: Analysis of retrieved polymeric surgical implants
� Part 4: Analysis of retrieved ceramic surgical implants.
Future parts will deal with other relevant aspects of medical device retrieval and analysis.
Annexes A and B of this part of ISO 12891 are for information only.
iv © ISO 2000 – All rights reserved
---------------------- Page: 4 ----------------------
ISO 12891-2:2000(E)
Introduction
The investigation of retrieved implantable medical devices and adjacent tissues can be of diagnostic value in case
of clinical complications, can deepen the knowledge about clinical implant performance and interactions between
implants and the body, provide information on implant performance and safety, and thus further the progress of the
development of biocompatible implant materials and devices with improved functional longevity.
This International Standard, with its several parts, gives guidance on the retrieval, handling and analysis of surgical
implants and associated biological specimens which are removed from patients either routinely, during revision
surgery, post mortem or for other reasons. The aim is to provide guidance in limiting iatrogenic damage to
associated biological material which could obscure the investigation results, and in gathering data at the proper
time and circumstance to validate the study. In associated portions of the various parts of this International
Standard, protocols for the collection of data and examinations are provided relating to specific types of material
and their typical applications. For particular investigation programmes, more specific protocols may be required. If
special analytical techniques are employed, the appropriate procedures should be specified.
This part of ISO 12891 offers guidelines for the analysis of retrieved metallic surgical implants to limit damage to
them, to indicate typical investigation techniques, and to allow comparisons between investigation results from
different sources. These guidelines may also serve for the documentation of clinical investigations. They may be
useful as well for retrieval and analysis studies in animals. Further parts of this International Standard describe
specific procedures for the retrieval and handling, and analysis methods applicable to surgical implants
manufactured of other than metallic materials.
ISO 12891-1 gives general guidelines on retrieval and handling, and applies to this and the other parts of
ISO 12891 which are related to the analysis of different categories of material. In the informative annexes B and C
of ISO 12891-1, examples are included for the collection of clinical and retrieval data. These data sets are not
repeated in the other parts of ISO 12891; they may be reduced or expanded depending on the retrieved surgical
implant, possibly attached or accompanying biological material, and the purpose of the retrieval and analysis.
© ISO 2000 – All rights reserved v
---------------------- Page: 5 ----------------------
INTERNATIONAL STANDARD ISO 12891-2:2000(E)
Retrieval and analysis of surgical implants —
Part 2:
Analysis of retrieved metallic surgical implants
1 Scope
This part of ISO 12891 provides guidance on the analyses of retrieved metallic surgical implants. Three stages of
investigations are described that are increasingly destructive. Guidance is given on the choice of stage and type of
investigation corresponding to the type of implant and purpose of the investigation.
NOTE This part of ISO 12891 should be applied in accordance with national regulations or legal requirements regarding
the handling and analysis of retrieved implants and associated biological material.
2 Normative reference
The following normative document contains provisions which, through reference in this text, constitute provisions of
this part of ISO 12891. For dated references, subsequent amendments to, or revisions of, this publication do not
apply. However, parties to agreements based on this part of ISO 12891 are encouraged to investigate the
possibility of applying the most recent edition of the normative document indicated below. For undated references,
the latest edition of the normative document referred to applies. Members of ISO and IEC maintain registers of
currently valid International Standards.
ISO 12891-1:1998, Retrieval and analysis of surgical implants — Part 1: Retrieval and handling.
3 Term and definition
For the purposes of this part of ISO 12891, the following term and definition applies.
3.1
metallic surgical implant
medical device consisting of metallic material intended to be inserted into the body by surgical techniques
NOTE 1 This device is hereafter addressed as "implant".
NOTE 2 The implant may consist of different components and may be covered or coated with metallic or non-metallic
material.
4 Procedures for retrieval, handling and packaging
Procedures for retrieval, handling, packaging and protection of personnel involved shall be in accordance with
ISO 12891-1.
NOTE As a precautionary measure, removed implants should be sterilized by an appropriate means that does not
adversely affect the implant or the planned investigation. Corresponding descriptions are found in ISO 12891-1:1998, annex A.
© ISO 2000 – All rights reserved 1
---------------------- Page: 6 ----------------------
ISO 12891-2:2000(E)
5 Analysis of the tissue/implant interface
A significant portion of the information associated with a retrieved implant device is often found at the device/tissue
interface. Attention should be given to a study of particles and degradation products in the peri-implant tissue.
Chemical analysis of the byproducts of degradation of the implant and a study of the cellular response to the
implant shall be considered.
Since the appearance of the tissue may vary rapidly with its distance from the implant surface, it is important that the
tissue is analysed in its context with the implant (see also relevant subclauses of ISO 12891-1:1998, such as 4.5).
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 through stage lll. The implant characterizations may include macroscopic and
microscopic examinations, chemical composition, as well as physical and mechanical properties.
Because of the complexity of analyses of the metallic materials that may be used for implants, and because of the
large number of potential analyses and tests suggested in this International Standard, the investigation is divided
into different stages. The investigations selected to be performed should depend upon the reason for removal of
the implant and possible restrictions in destructive testing. Perform a minimum number of investigations for routine
removals where the implant is not suspect; more testing for implants suspected of impaired function, and extensive
investigations for implants removed because of their performance, behaviour or malfunction.
Perform a separate analysis for each component of the implant, if possible and necessary. Consider other relevant
parts of this International Standard if materials other than metals are involved.
6.2 Standard forms
A standard form, indicating the information to be recorded at each stage of investigation, is given in annex A as a
framework. Portions of this form that do not apply in an implant analysis can be omitted. On the other hand, the
form may be extended and modified.
A standard form for the recording of a minimum of clinical information and of additional clinical material is provided
in annex B of ISO 12891-1:1998.
6.3 Stage I investigation — Macroscopic examination (non-destructive)
6.3.1 Identification/Photography
Markings found on the implant, such as logos, article numbers, lot numbers, dimensions, etc., shall be recorded
(see annex A). Where useful, photographic documentation of relevant findings should be kept.
6.3.2 Visual examination
Observe the implant surface by suitable techniques to ascertain any mode of destruction or failure, if such appears.
In no event shall any surface of a failed implant be destructively evaluated at this stage.
6.3.3 Low-power optical examination
Perform an overall examination under a low-power optical stereomicroscope. Record an estimate as to the degree
of findings as suggested in annex A.
2 © ISO 2000 – All rights reserved
---------------------- Page: 7 ----------------------
ISO 12891-2:2000(E)
6.3.4 Further
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.