1、BSI Standards PublicationBS ISO 12891-2:2014Retrieval and analysis ofsurgical implantsPart 2: Analysis of retrieved surgicalimplantsBS ISO 12891-2:2014 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 12891-2:2014. The UK participation in its preparation was ent
2、rusted to TechnicalCommittee CH/150, Implants for surgery.A list of organizations represented on this committee can be obtained on request to its secretary.This publication does not purport to include all the necessary provisions of a contract. Users are responsible for its correct application. The
3、British Standards Institution 2014.Published by BSI Standards Limited 2014ISBN 978 0 580 74600 0 ICS 11.040.40 Compliance with a British Standard cannot confer immunity from legal obligations.This British Standard was published under the authority of the Standards Policy and Strategy Committee on 30
4、 September 2014.Amendments/corrigenda issued since publicationDate T e x t a f f e c t e d ISO 2014Retrieval and analysis of surgical implants Part 2: Analysis of retrieved surgical implantsRetrait et analyse des implants chirurgicaux Partie 2: Analyse des implants chirurgicaux mtalliques retirsINTE
5、RNATIONAL STANDARDISO 12891-2Second edition 2014-09-15Reference number ISO 12891-2:2014(E)BS ISO 12891-2:2014ISO 12891-2:2014(E)ii ISO 2014 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2014All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utiliz
6、ed 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 ISOs member body in the country of the requester.ISO copyright
7、officeCase postale 56 CH-1211 Geneva 20Tel. + 41 22 749 01 11Fax + 41 22 749 09 47E-mail copyrightiso.orgWeb www.iso.orgPublished in SwitzerlandBS ISO 12891-2:2014ISO 12891-2:2014(E) ISO 2014 All rights reserved iiiContents PageForeword ivIntroduction v1 Scope . 12 Normative references 13 Terms and
8、definitions . 14 Procedures for retrieval, handling and packaging . 15 Analysis of the implant interfaces 25.1 Implant/tissue interface . 25.2 Implant/implant interfaces 26 Analysis of the implant . 26.1 General . 26.2 Forms for recording the results of the analyses . 36.3 Stage I investigation (mac
9、roscopic examination non-destructive) 36.4 Stage II investigation (microscopic examination mostly non-destructive) . 36.5 Stage III investigation (material investigation mostly destructive) . 46.6 Surface-treated or coated implants . 66.7 Biodegradable implants 67 Implant performance 7Annex A (norma
10、tive) Standard forms for the analysis of retrieved surgical implants 8Annex B (informative) ISO Standards applicable for the evaluation of materials .22Bibliography .26BS ISO 12891-2:2014ISO 12891-2:2014(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of
11、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. Inte
12、rnational 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 int
13、ended 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 ww
14、w.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
15、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 expre
16、ssions related to conformity assessment, as well as information about ISOs adherence to the WTO principles in the Technical Barriers to Trade (TBT) see the following URL: Foreword - Supplementary informationThe committee responsible for this document is ISO/TC 150, Implants for surgery.This second e
17、dition 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:
18、 Analysis of retrieved surgical implantsiv ISO 2014 All rights reservedBS ISO 12891-2:2014ISO 12891-2:2014(E)IntroductionThe 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 clin
19、ical 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 ana
20、lysis 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 pro
21、per 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
22、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 re
23、sults 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
24、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. Th
25、ey 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. ISO 2014 All rights reserved vBS ISO 12891-2:2014BS ISO 12891-2:2014Retrieval and analysis of surgical implants
26、Part 2: Analysis of retrieved surgical implants1 ScopeThis 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 incr
27、easingly 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 bio
28、logical material.2 Normative referencesThe 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 (inc
29、luding any amendments) applies.ISO 12891-1:2011, Implants for surgery Retrieval and analysis of surgical implants Part 1: Retrieval and handling3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.3.1surgical implantimplantmedical device intended to be
30、inserted into the body by surgical techniquesNote 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 packagingProcedures for retrieval, handling, packa
31、ging, 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 1
32、2891-1:2011.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 shou
33、ld be chosen to minimize this risk.INTERNATIONAL STANDARD ISO 12891-2:2014(E) ISO 2014 All rights reserved 1BS ISO 12891-2:2014ISO 12891-2:2014(E)Photographic records of the surgical field should be made before the implant retrieval, if appropriate.5 Analysis of the implant interfaces5.1 Implant/tis
34、sue interfaceA 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
35、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 res
36、idues 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 s
37、amples should be collected for further analysis (see ISO 12891-1, 3.4).5.2 Implant/implant interfacesWhere 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 consider
38、ed 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 implant6.1 GeneralThis clause describes the different degrees of characterization to be co
39、nsidered 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,
40、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
41、 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 f
42、or 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 a suspected malfunction.Each component of an implant shall be analysed separately,
43、if possible and necessary.NOTE 1 Annex A lists the most important characteristics to be assessed at each investigational stage.NOTE 2 Applicable International Standards and national standards for the evaluation of implant properties are given in Annex B and in the Bibliography.2 ISO 2014 All rights
44、reservedBS ISO 12891-2:2014ISO 12891-2:2014(E)6.2 Forms for recording the results of the analysesStandard forms for metallic (see A.2), polymeric (see A.3), and ceramic (see A.4) implants, indicating the information to be recorded at each stage of the investigation are given as a framework. Further
45、information regarding the use of the forms is given in A.1.For other materials, e.g. animal tissue implants, a form based on A.2 to A.4 can be used for the preparation of a relevant list.NOTE A standard form for the recording of clinical and implant-related information is given in ISO 12891-1:2011,
46、Annex A.6.3 Stage I investigation (macroscopic examination non-destructive)6.3.1 GeneralThe primary aim of this stage of the investigation is to describe the product (type, manufacturer, etc.), to collect the pertinent visual information and to establish the failure assessment plan.For the assessmen
47、t of the Stage I investigation, use sections 1 and 2 in A.2, A.3, or A.4.6.3.2 Identification/photographyMarkings found on the implant or its components such as the manufacturers name or trademark, the batch code (lot number) or serial number, dimensions, etc., shall be recorded. Photographic record
48、s shall be made of relevant findings, where useful.6.3.3 Visual examinationThe implant surface shall be observed to ascertain the mode of failure, destruction, or surface alteration, if any such appears.In no event shall any surface of a failed implant be destructively evaluated at this stage.6.3.4
49、Low-power optical examinationAn overall examination shall be performed under a low-power optical stereomicroscope.6.3.5 Further evaluationIf at the conclusion of stage I further investigation is required to clarify any observations made, or to evaluate other characteristics or the failure mode of the implant, it shall be carried out subsequently in stage II.6.4 Stage II investigation (microscopic examination mostly non-destructive)6.4.1 GeneralStage II investigation shall be carried out after stage I investigation, if deemed necessary, to furt
