BS ISO 12891-1-2015 Retrieval and analysis of surgical implants Retrieval and handling《外科植入物的取出与分析 取出与处理》.pdf

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1、BSI Standards PublicationBS ISO 12891-1:2015Retrieval and analysis ofsurgical implantsPart 1: Retrieval and handlingBS ISO 12891-1:2015 BRITISH STANDARDNational forewordThis British Standard is the UK implementation of ISO 12891-1:2015.It supersedes BS ISO 12891-1:2011 which is withdrawn.The UK part

2、icipation in its preparation was entrusted to TechnicalCommittee CH/150, Implants for surgery.A list of organizations represented on this committee can beobtained on request to its secretary.This publication does not purport to include all the necessaryprovisions of a contract. Users are responsible

3、 for its correctapplication. The British Standards Institution 2015. Published by BSI StandardsLimited 2015ISBN 978 0 580 89069 7ICS 11.040.40Compliance with a British Standard cannot confer immunity fromlegal obligations.This British Standard was published under the authority of theStandards Policy

4、 and Strategy Committee on 30 June 2015.Amendments issued since publicationDate Text affectedBS ISO 12891-1:2015 ISO 2015Retrieval and analysis of surgical implants Part 1: Retrieval and handlingRetrait et analyse des implants chirurgicaux Partie 1: Retrait et manipulationINTERNATIONAL STANDARDISO12

5、891-1Third edition2015-07-01Reference numberISO 12891-1:2015(E)BS ISO 12891-1:2015ISO 12891-1:2015(E)ii ISO 2015 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2015, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilize

6、d 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 o

7、fficeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 12891-1:2015ISO 12891-1:2015(E)Foreword ivIntroduction v1 Scope . 12 Terms and definitions . 13 Method 23.1 Obtaining the clinical history of the implant and

8、patient 23.2 Pre-explantation checks and examinations . 23.3 Collecting the surgical implant . 23.4 Collecting the tissue and fluid samples 33.5 Photographic record of the explantation . 33.6 Containing and labelling the retrieved surgical implant, tissues, and fluids for future identification 43.7

9、Cleaning the retrieved surgical implant 43.8 Decontaminating the retrieved surgical implant 63.9 Packaging the retrieved surgical implant, tissues, and fluids for shipment. 73.10 Use of coolant materials 83.11 Labelling of the packing materials . 83.12 Documentation to be supplied with retrieved sur

10、gical implants 83.13 Unpacking following shipment . 93.14 Cleaning and decontamination following shipment . 93.15 Documentation to be maintained during examination, analysis, and storage . 94 Analysis of retrieved surrounding tissues and fluids. 95 Infection control . 95.1 General . 95.2 Work practi

11、ces 105.3 Personal protective equipment 105.3.1 General. 105.3.2 Gloves 105.3.3 Masks, eye protection, and face shields 105.3.4 Gowns, aprons, and other protective body clothing .115.4 Maintenance of the worksite 115.4.1 Cleaning and disinfection of worksites 115.4.2 Protective coverings .115.4.3 Eq

12、uipment and tools .115.4.4 Reusable receptacles .125.4.5 Contaminated glassware 125.4.6 Reusable items 125.4.7 Contaminated materials . 125.5 Human waste disposal . 125.6 Special practices . 13Annex A (informative) Suggested minimum information to be obtained for retrieved surgical implants .14Annex

13、 B (informative) Generic procedures for the decontamination of surgical implants.17Annex C (informative) Analyses to be performed on retrieved tissue samples and fluids .23Bibliography .24 ISO 2015 All rights reserved iiiContents PageBS ISO 12891-1:2015ISO 12891-1:2015(E)ForewordISO (the Internation

14、al 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 e

15、stablished 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 standard

16、ization.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

17、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 an

18、y 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

19、.For an explanation on the meaning of ISO specific terms and expressions 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 information.The committee responsible

20、for this document is ISO/TC 150, Implants for surgery.This third edition cancels and replaces the second edition (ISO 12891-1:2011), which has been technically revised.ISO 12891 consists of the following parts, under the general title Retrieval and analysis of surgical implants: Part 1: Retrieval an

21、d handling Part 2: Analysis of retrieved surgical implantsiv ISO 2015 All rights reservedBS ISO 12891-1:2015ISO 12891-1:2015(E)IntroductionThe investigation of retrieved surgical implants, adjacent tissues, and associated fluids can be undertaken to determine the cause of a clinical complication or

22、surgical implant failure, improve knowledge of surgical implant performance and safety, improve knowledge of the interactions of surgical implants and the human body, and develop materials with improved biocompatibility and implants with improved functional longevity.This International Standard spec

23、ifies methods for the retrieval, handling, and analysis of surgical implants and associated tissue samples and fluids which are removed from patients during retrieval surgery or post-mortem. ISO 12891-2 specifies methods for the detailed analysis of surgical implants, in which protocols are provided

24、 for the collection of data and examinations for surgical implants in relation to their typical applications. For particular investigation programmes, additional, more specific, protocols can be required. If special analytical techniques are employed, the appropriate handling procedures need to be s

25、pecified.The purpose of this International Standard is to specify a method for the retrieval of surgical implants which is intended to prevent damage to implants, associated tissues, and fluids, ensure that retrieved materials are handled safely and decontaminated correctly and that the risk of tran

26、smission of infectious diseases is minimized, ensure that the retrieval process is properly documented, and allow comparisons between investigation results from different sources.Many variables are involved when undertaking the retrieval of surgical implants. The retrieval can be for the routine rep

27、lacement of a pacemaker battery or it can be for the revision of a defective surgical implant. The retrieval can be from a living patient or it can be a post-mortem study. The retrieval can involve the removal of a single surgical implant or multiple components as, for example, in the case of hip re

28、placements or certain fracture fixation or spinal devices. In addition to the retrieval of the surgical implant, associated tissues and fluids might also need to be removed. The retrieval can involve a wide variety of personnel such as surgeons, nurses, other hospital staff, surgical implant manufac

29、turer, investigator, and shipping service. Finally, the type of analysis to be performed can vary and can include visual, chemical, histological, and microbiological studies and the eventual analysis can have an impact on the retrieval process. These variables make it impossible to specify a single

30、method which has to be followed in all retrieval cases. For this reason, certain requirements listed in this part of ISO 12891 might only be applicable in certain circumstances and for this reason, some of the requirements are prefaced with statements such as “If applicable” or “Whenever possible”.T

31、his International Standard presents a methodology for the systematic retrieval of surgical implants. It focuses on the practical requirements in particular. In addition to these requirements, there are legal and ethical considerations which might need to be taken into account. These considerations i

32、nclude matters relating to the ownership of the implant, the obtaining of the patients consent before the implant is retrieved, the patients right to confidentiality, and the need to protect the patients safety, health, and litigation rights throughout. For a detailed consideration of these issues,

33、appropriate advice can be sought.NOTE The methods specified in this International Standard can also be applicable to the retrieval and analysis of surgical implants in animal studies. ISO 2015 All rights reserved vBS ISO 12891-1:2015BS ISO 12891-1:2015Retrieval and analysis of surgical implants Part

34、 1: Retrieval and handling1 ScopeThis part of ISO 12891 specifies the method to be followed for the retrieval and handling of surgical implants and associated tissues and fluids. In particular, it specifies the essential steps to be followed for the safe and proper obtaining of the clinical history,

35、 pre-explantation checks and examinations, collection, labelling, cleaning, decontamination, documentation, packing and shipping. This part of ISO 12891 also provides guidance on infection control.NOTE National or other regulations, which can be more stringent, can apply.This part of ISO 12891 does

36、not apply in cases of explantation where there is no intention to collect retrieval data. However, many clauses give useful information which can apply in these cases also.2 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.2.1absorbentmaterial capable

37、 of absorbing liquidsNote 1 to entry: Absorbent material can either be particulate or non-particulate.2.2contaminationunintentional addition or modification, including exposure to a potentially infectious agent2.3infectious wastewaste containing or suspected to contain human pathogenic microbiologic

38、al agents2.4outer shipping containeroutermost container in which the package is finally shipped2.5primary containertube, envelope, or other impermeable container which holds the retrieved material to be shipped2.6secondary containercontainer into which the primary container is placedINTERNATIONAL ST

39、ANDARD ISO 12891-1:2015(E) ISO 2015 All rights reserved 1BS ISO 12891-1:2015ISO 12891-1:2015(E)3 Method3.1 Obtaining the clinical history of the implant and patientWhenever possible, the clinical history of the patient and the surgical implant shall be obtained and recorded. This clinical history sh

40、all include at least the following, if available: name or identification number of the patient as permitted by the applicable national regulations; original diagnosis which resulted in the use of the surgical implant; X-ray of the surgical implant in situ taken after the insertion operation; patient

41、s activity level including the ability to perform work, sports, and recreational activities; patients medical history relevant to the surgical implant, including the hospital or clinic at which the surgical implant was implanted; information on the patients experience with the surgical implant just

42、before surgical implant retrieval; date of retrieval; hospital or clinic at which the surgical implant was retrieved.The information obtained should be treated as confidential.NOTE 1 Annex A gives an example of the information to be obtained. The annex can be modified as necessary, e.g. for special

43、investigations.NOTE 2 In any analysis of an explanted surgical implant, it is advantageous to have as much relevant knowledge of the clinical history as possible.3.2 Pre-explantation checks and examinationsWhenever possible, data which might be lost post-explantation should be collected prior to exp

44、lantation.Whenever possible, a functional check of the implant involving an objective measurement shall be performed before explantation surgery.NOTE A functional check assists in the understanding of the post-explantation behaviour.If applicable, electronic or other data associated with the surgica

45、l implant shall be collected before the implant is explanted. These data should be provided to the evaluator of the surgical implant.Where appropriate and justifiable, taking into account the need for patient safety, non-invasive examinations of the implantation site with the implant in situ shall b

46、e performed before the implant is explanted. Such examinations may include X-ray, computed axial tomography scan, or magnetic resonance imaging.3.3 Collecting the surgical implantTaking into account the need for patient safety, the surgical implant shall be retrieved in a manner which causes as litt

47、le damage as possible to both the surgical implant and the surrounding tissues. As far as possible, functional surfaces, e.g. bearing surfaces of joint prostheses, mechanical connections, e.g. hinges, joints, screws, and fracture surfaces of broken surgical implants, shall be protected during and af

48、ter explantation.Fragments and debris which can provide valuable information shall also be retrieved.Retrieved surgical implants should be handled with care either by hand or using appropriate instruments.2 ISO 2015 All rights reservedBS ISO 12891-1:2015ISO 12891-1:2015(E)The following shall be docu

49、mented:a) position or orientation or state of the retrieved components, if there is more than one retrieved component and if the position or orientation or state is abnormal;b) location and type of damage, if damage occurs during explantation.NOTE For proper scientific examination, it is advantageous for the surgical implant to be maintained in a state as close as possible to that in which it existed at the time of retrieval.3.4 Collecting the tissue and fluid samplesTaking into account the need for patient safety, if tissue and/or fluid