BS ISO 8828-2014 Implants for surgery Guidance on care and handling of orthopaedic implants《外科植入物 骨科植入物的护理和处理指南》.pdf

1、BSI Standards Publication BS ISO 8828:2014 Implants for surgery Guidance on care and handling of orthopaedic implantsBS ISO 8828:2014 BRITISH STANDARD National foreword This British Standard is the UK implementation of ISO 8828:2014. The UK participation in its preparation was entrusted to Technical

2、 Committee 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 British Standard

3、s Institution 2014. Published by BSI Standards Limited 2014 ISBN 978 0 580 74583 6 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 31 December 201

4、4. Amendments/corrigenda issued since publication Date T e x t a f f e c t e dBS ISO 8828:2014 ISO 2014 Implants for surgery Guidance on care and handling of orthopaedic implants Implants chirurgicaux Principes directeurs pour lentretien et la manipulation des implants orthopdiques INTERNATIONAL STA

5、NDARD ISO 8828 Second edition 2014-11-15 Reference number ISO 8828:2014(E)BS ISO 8828:2014ISO 8828:2014(E)ii ISO 2014 All rights reserved COPYRIGHT PROTECTED DOCUMENT ISO 2014 All rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherwise in any

6、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 office Case postale

7、 56 CH-1211 Geneva 20 Tel. + 41 22 749 01 11 Fax + 41 22 749 09 47 E-mail copyrightiso.org Web www.iso.org Published in SwitzerlandBS ISO 8828:2014ISO 8828:2014(E)Contents Page Foreword iv Introduction v 1 Scope . 1 2 T erms and definitions . 1 3 General guidance 1 3.1 Manufacturers instructions 1 3

8、.2 On receipt 1 3.3 Transport . 2 3.4 Stock records 2 3.5 Storage . 3 3.6 Stock rotation . 3 3.7 Cleaning and sterilization of non-sterile implants . 3 3.8 Appearance 4 3.9 Contouring and modifying implants 4 3.10 Re-use . 4 4 Additional guidance on polymeric implants and materials 4 4.1 Sterilizati

9、on 4 4.2 Acrylic bone cement . 4 4.3 Silicone implants . 4 4.4 Biodegradable implants 4 5 Additional guidance on ceramic components 5 5.1 Sterilization and handling . 5 5.2 Dropping of ceramic components 5 5.3 Manufacturers instructions 5 6 Additional guidance on implants or components of implants w

10、ith rough surfaces or surfaces with intrinsic porosity 5 6.1 Sterile implants. 5 6.2 Subsequent cleaning of implants 5 6.3 Non-sterile implants 5 Bibliography 6 ISO 2014 All rights reserved iiiBS ISO 8828:2014ISO 8828:2014(E) Foreword ISO (the International Organization for Standardization) is a wor

11、ldwide 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

12、 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

13、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 Dire

14、ctives, 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 devel

15、opment 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

16、 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 for this document is ISO/TC 150, Implants

17、 for surgery. This second edition cancels and replaces the first edition (ISO 8828:1988), which has been technically revised.iv ISO 2014 All rights reservedBS ISO 8828:2014ISO 8828:2014(E) Introduction The guidance given in this International Standard on the care and handling of orthopaedic implants

18、 after delivery to the purchaser is intended to help ensure that implants remain free from contamination or damage prior to insertion into the patient. Guidance is given on the procedures for receiving, storing, transporting, handling, cleaning, and sterilizing implants. Guidance on procedures for p

19、reparing the implants for use, as well as handling during the surgery, are also outlined. This guidance is aimed at all personnel involved in receiving and handling implants, including surgeons. It is important that all personnel be familiar with recommended procedures in order to minimize the risk

20、and occurrence of damage to implants. ISO 2014 All rights reserved vBS ISO 8828:2014BS ISO 8828:2014Implants for surgery Guidance on care and handling of orthopaedic implants 1 Scope This International Standard specifies the recommended procedures for handling orthopaedic implants, hereafter referre

21、d to as implants, from receipt at the hospital until they are implanted or discarded. This guidance applies to implants (such as currently used metal, ceramic, or polymeric implants) and also to acrylic resin and other bone cements. This guidance does not apply to the implant manufacturer. However,

22、it contains references to the stocking of implants that can be useful for manufacturers and especially for third-party suppliers. 2 T erms a nd definiti ons For the purposes of this document, the following terms and definitions apply. 2.1 orthopaedic implant implant device implanted surgically, whol

23、ly or partially, in the body, either temporarily or permanently, and used either as an aid in the repair of bone or related tissues, or as a temporary or permanent replacement for these tissues Note 1 to entry: Acrylic resin cement, used for fixing certain devices, is deemed to be an “implant”. 3 Ge

24、neral guidance 3.1 Manufacturers instructions All of the manufacturers instructions should be followed and take precedence over the guidance provided in this International Standard. 3.2 On receipt 3.2.1 General Packaged implants can arrive either a) pre-sterilized (see 3.2.2), or b) non-sterilized (

25、see 3.2.3). 3.2.2 Products supplied sterile The packaging of products supplied sterile shall be left intact until the time of use. The packaging shall be inspected for damage. If damage is found, the implant shall be considered non-sterile. The implant shall then either a) be returned to the manufac

26、turer for reprocessing, or, INTERNATIONAL ST ANDARD ISO 8828:2014(E) ISO 2014 All rights reserved 1BS ISO 8828:2014ISO 8828:2014(E) b) if appropriate and not prohibited by the device manufacturer, be taken out of the damaged packaging and re-sterilized in the user facility following the directions f

27、or an applicable method of sterilization provided in the instructions for use. NOTE Guidance about information to be provided by the manufacturer for the processing of re-sterilizable medical devices is given in ISO 17664. 3.2.3 Non-sterile implants Some non-sterile implants can be received in speci

28、al packaging that is suitable for sterilization using the method(s) specified by the manufacturer in the instructions for use. The implant shall not be removed from this packaging prior to sterilization. Non-sterile implants not packaged in this way should only be unwrapped immediately prior to ster

29、ilization so as to preserve the surface finish and configuration intact, and they should be handled as infrequently as possible. The implant shall be sterilized following the directions for an applicable method of sterilization provided in the instructions for use. 3.2.4 Usability of implants Any im

30、plant that has been dropped or mishandled and which is suspected of having suffered damage shall not be used. The implant should be disposed of or returned to the manufacturer as directed in the instructions for use. However, the final judgement as to the suitability of the implant shall always lie

31、with the surgeon who uses the implant provided there are no restrictions in the instructions for use. If such an implant is used, the patient record shall include a description of the mishandling and any methods used to mitigate the possible effects of the mishandling on the safety and efficacy of t

32、he device. 3.3 Transport Care shall be exercised during transport and handling of the implants so as to preclude any damage or alteration to the condition of the implant and its packaging as received. Attention shall be paid to the handling conditions specified by the manufacturer on the label of th

33、e outermost layer of packaging. 3.4 Stock records 3.4.1 General Stock records are required to facilitate inventories, stock rotation, traceability to the manufacturer, and, in some instances, for transfer to patients records. 3.4.2 Lot or batch code or serial number The label of the implant package

34、should bear the model designation of the device and in most cases a lot or batch code or serial number of the implant. Also, some implants are marked on their surface with the lot or batch code or serial number. The lot, batch code, or serial number of the implant shall be transferred to the patient

35、s record. 3.4.3 Records to be compiled The following information shall be recorded: a) the name of the manufacturer; b) a description of the implant including, if applicable, the model designation, the implant material(s), and the characteristic dimensions;2 ISO 2014 All rights reservedBS ISO 8828:2

36、014ISO 8828:2014(E) c) the lot or batch code or serial number of the implant; d) the number of implants in a package unit; e) the “use by” date or date of manufacture as appropriate; f) the date of receipt by the hospital. 3.5 Storage 3.5.1 General In all storage areas, implants shall be stored prio

37、r to use so as to maintain the configuration and surface finish of the implant and to avoid damage to its packaging, particularly to the sterile packaging. Implants should be stored separately from instruments. Non-sterile implants shall be stored separately from those that have been sterilized. 3.5

38、.2 Storage conditions The implant shall be stored in a suitable area following the conditions specified by the manufacturer on the label of the outermost layer of packaging or in the instructions for use (e.g. temperature, humidity, and ambient pressure). If there are no such instructions, implants

39、shall be stored in dry conditions and shall not be exposed to direct sunlight, ionizing radiation, extremes of temperature, or particulate contamination. 3.6 Stock rotation The principle of “first in, first out” is recommended. The practice of stock rotation should be adopted for all implants, steri

40、le and non-sterile, in all storage areas. 3.7 Cleaning and sterilization of non-sterile implants 3.7.1 Non-sterile implants can be sterilized without prior cleaning if the manufacturers packaging has been removed immediately prior to sterilization. 3.7.2 After each surgical procedure, all implants t

41、hat can be subjected to a resterilization procedure shall be thoroughly and carefully cleaned according to the manufacturers instructions for use. Ultrasonic cleaning, mechanized washing, or scrubbing by hand are suitable methods provided that they are carried out carefully. The method used shall pr

42、event impact, scratching, bending, or surface contact with any materials that might affect the implant surface or configuration. 3.7.3 The manufacturers recommendations on cleaning shall be closely complied with. If scrubbing by hand is used, soft brushes shall be used and harsh chemicals or harsh c

43、leaning solutions shall be avoided. 3.7.4 After cleaning, the implants shall be rinsed completely free of all residues, soap, detergent, or cleaning solutions. After rinsing, the implants shall be thoroughly dried. Special attention shall be paid to recesses since both chemicals and rinse water can

44、be entrapped in them. If a cloth is used for the final implant cleaning or drying, this cloth shall be made of antistatic material so that dirt and dust from the environment are not attracted by the implant surface because of an electrostatic charge. 3.7.5 All implants shall be sterilized in accorda

45、nce with the method(s) specified by the manufacturer in the instructions for use. 3.7.6 Implants shall not be sterilized in contact with instruments or with implants of other materials as metallic oxide and other contaminants could transfer to the implant, thus causing an unacceptable condition when

46、 implanted. ISO 2014 All rights reserved 3BS ISO 8828:2014ISO 8828:2014(E) 3.8 Appearance Implants that show signs of surface or configuration damage shall be disposed of or returned to the manufacturer if directed in the instructions for use. 3.9 Contouring and modifying implants 3.9.1 Performance

47、characteristics of the implant can be altered by contouring or modifying the implant. Contouring or modifying the implant should be avoided, but if strictly necessary, the manufacturers given instructions for use shall be followed. 3.9.2 Contouring or clamping of implants, a procedure which is frequ

48、ently necessary, shall be carried out by the surgeon in a manner that will least alter the performance of the implant. However, it is recommended that metallic implants should not be bent sharply, re-bent, angulated at a screw hole, notched, or scratched. 3.9.3 Implants shall not be contoured or mod

49、ified by the use of instruments that have been damaged or the effectiveness of which has been impaired. 3.10 Re-use Implants previously implanted shall not be re-used. 4 Additional guidance on polymeric implants and materials 4.1 Sterilization Special attention shall be given when using the manufacturers recommended methods to sterilize most polymeric implants and materials; otherwise the process can cause degradation or other adverse effects. In those instances where resterilization is possible, the manufacturers recommended met