ISO 12891-4:2000
(Main)Retrieval and analysis of surgical implants — Part 4: Analysis of retrieved ceramic surgical implants
Retrieval and analysis of surgical implants — Part 4: Analysis of retrieved ceramic surgical implants
Retrait et analyse des implants chirurgicaux — Partie 4: Analyse des implants chirurgicaux en céramique retirés
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Standards Content (Sample)
INTERNATIONAL ISO
STANDARD 12891-4
First edition
2000-02-01
Retrieval and analysis of surgical
implants —
Part 4:
Analysis of retrieved ceramic surgical
implants
Retrait et analyse des implants chirurgicaux —
Partie 4: Analyse des implants chirurgicaux en céramique retirés
Reference number
ISO 12891-4:2000(E)
©
ISO 2000
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ISO 12891-4:2000(E)
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ISO 12891-4:2000(E)
Contents
Foreword.iv
Introduction.v
1 Scope .1
2 Normative reference .1
3 Term and definition .1
4 Retrieval, handling and packaging .2
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 Standard form for various stages of the investigation.2
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 .5
6.7 Biodegradable ceramic implants .5
7 Implant performance .5
Annex A (informative) Standard form for the analysis of retrieved ceramic surgical implants.6
Annex B (informative) Test methods for the evaluation of ceramic materials.10
Bibliography.12
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ISO 12891-4:2000(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 12891-4 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
Annexes A and B of this part of ISO 12891 are for information only.
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ISO 12891-4:2000(E)
Introduction
The investigation of retrieved surgical implants and adjacent tissues can be of diagnostic value in the event of
clinical complications, can deepen the knowledge about clinical implant performance and interactions between
implants and the body, and can provide information on implant performance and safety, thus furthering the
development of biocompatible implant materials and implants with improved functional longevity.
This part of ISO 12891 offers guidelines for the analysis of retrieved ceramic surgical implants to ensure they are
not damaged, 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
also be useful for retrieval and analysis studies in animals. Other parts of ISO 12891 describe detailed procedures
for the retrieval and handling of implants manufactured from materials other than ceramics, as well as methods of
analysis (see the foreword).
ISO 12891-1 gives general guidelines on retrieval and handling and applies to this part ISO 12891 as well as to the
other parts, which are related to the analysis of different categories of material. Informative annexes B and C of
ISO 12891-1:1998 include examples of protocols for reporting data concerning the retrieval process. These
protocols are not repeated in the other parts 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.
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INTERNATIONAL STANDARD ISO 12891-4:2000(E)
Retrieval and analysis of surgical implants —
Part 4:
Analysis of retrieved ceramic surgical implants
1 Scope
The various parts of ISO 12891 give recommendations for the retrieval, handling and analysis of surgical implants
and associated specimens which are removed from patients routinely, 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 to validate the study. Part 1 deals with
retrieval and handling. Parts 2 to 4 concern the analysis of implants of specific materials, including protocols for
reporting the data collected. For particular investigation programmes, additional, more specific, protocols may be
required. If special analytical techniques are employed, the appropriate procedures should be specified.
This part of ISO 12891 provides guidance on the analysis of retrieved ceramic surgical implants. For general
information on ceramics, see the bibliography. The investigation is divided into three stages that are increasingly
destructive. The stage and type of investigation should be chosen as a function of the type of implant and the
purpose of the investigation.
This part of ISO 12891 concerns "dense", "stable" ceramics such as alumina and tetragonal zirconia. However,
where suitable, sections of this part of ISO 12891 may be also applied to less stable ceramics like hydroxyapatite
or bio-accessible ceramics like tricalcium phosphate. In clause 6, some provisions are made for analyses of such
types of ceramic.
This part of ISO 12891 should be used in accordance with national regulations or legal requirements concerning
the handling and analysis of retrieved implants and tissues 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 apply.
3.1
ceramic surgical implant
surgical implant consisting of ceramic material intended to be inserted into the body by surgical techniques
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ISO 12891-4:2000(E)
NOTE 1 It is also referred to simply as an "implant".
NOTE 2 The term may also be used for a component of a compound implant.
4 Retrieval, handling and packaging
Procedures for retrieval, handling, packaging and protection of the personnel involved are found in 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. Suitable methods can be found in ISO 12891-1.
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 should be given to particles in the peri-implant tissue. Where possible, analyses of the
chemistry and nature of the byproducts of degradation of the implant and a study of the cellular response to the
implant should be considered.
In cases where implant surfaces are structured to the effect that tissue ingrowth is invited, the study of the implant
tissue interface is of particular interest, and the findings should be recorded. One may even detect microscopic
adherent tissue residues on surfaces where no attached tissue has been retrieved intentionally together with the
implant.
Since the appearance of the tissue may vary rapidly with the distance from the implant surface, it is important that
the tissue is analysed in its context with the implant (see also the relevant sections of ISO 12891-1:1998, such as
4.5).
5.2 Implant/implant interfaces
Where ceramic implants articulate or are in contact with other implant components, the condition of the contacting
surface areas of the implant may be of particular interest. Their study should be considered in the context of the
opposing surface, and that part of ISO 12891 which concerns the material of this opposite component may be
consulted.
6 Analysis of the implant
6.1 General
This clause describes implant examinations to be considered when a retrieved implant is under investigation. The
analyses of the implant are separated into three stages, with the degree of investigation increasing from stage I to
stage III. The implant investigation may include macroscopic and microscopic examinations, chemical analyses and
the determination of physical and mechanical properties.
6.2 Standard form for various stages of the investigation
A standard form indicating the information to be recorded at each stage of the investigation is given in annex A.
This form is a framework. Sections of the form that do not apply to a particular implant analysis can be neglected.
The form may also be expanded or modified.
A standard form for recording the minimum clinical information, as well as additional clinical material, is given in
annex B of ISO 12891-1:1998.
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ISO 12891-4:2000(E)
Analyse each component of an implant separately, if possible and necessary. Consider other relevant parts of
ISO 12891 if materials other than ceramics are involved. Because of the complexity of analyses of the variety of
ceramic materials that may be used for implants, and because of the large number of potential analyses and tests
suggested in this part of ISO 12891, the investigation is divided into different stages. The examinations selected will
depend upon the reasons for removal and examination of the implant, and possible restrictions in destructive
testing. Perform a minimum number of examinations for routine removals where the implant is not suspected to
have malfunctioned, more examinations for implants suspected of having a functional impairment, and extensive
examinations for implants removed because of their poor performance or behaviour or because of a malfunction.
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., should be recorded
(see annex A). Photographic documentation of relevant findings should be made where useful.
6.3.2 Visual examination
Check the implant surface by suitable techniques to ascertain the mode of failure, destruction or surface alteration,
if any such appears. In no event should 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 stereo-microscope. Record the findings as per annex A.
6.3.4 Further evaluation
If at the conclusion of stage I further investigation is required to clarify any observations made, to evaluate other
characteristics or to evaluate the mode of failure of the implant, it should be carried out subsequently in stage II.
6.4 Stage II investigation (microscopic examination — mostly non-destructive)
6.4.1 General
Stage II should be carried out after stage I, if deemed necessary, to evaluate further the characteristics and/or
failure mode of the implant. The primary aim of this stage of the investigation is to assess the mode of failure and
the deterioration of the implant in the most non-destructive manner possible (see annex A).
6.4.2 Microscopic examination
Use standard optical-microscope or electron-microscope examination techniques suitable for the material under
investigation.
When scanning electron microscopy is used, special preparation techniques
...
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