BS ISO 19213-2017 Implants for surgery Test methods of material for use as a cortical bone model《外科植入物 用作皮质骨模型的材料的试验方法》.pdf

1、Implants for surgery Test methods of material for use as a cortical bone modelBS ISO 19213:2017BSI Standards PublicationWB11885_BSI_StandardCovs_2013_AW.indd 1 15/05/2013 15:06 ISO 2017Implants for surgery Test methods of material for use as a cortical bone modelImplants chirurgicaux Mthodes dessai

2、des matriaux destins servir de modle dos corticalINTERNATIONAL STANDARDISO19213First edition2017-07Reference numberISO 19213:2017(E)National forewordThis British Standard is the UK implementation of ISO 19213:2017.The UK participation in its preparation was entrusted to Technical Committee CH/150/5,

3、 Surgical Implants - Osteosynthesis and spinal devices.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 Bri

4、tish Standards Institution 2017 Published by BSI Standards Limited 2017ISBN 978 0 580 86925 9ICS 11.040.40Compliance 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 July

5、 2017.Amendments/corrigenda issued since publicationDate Text affectedBRITISH STANDARDBS ISO 19213:2017 ISO 2017Implants for surgery Test methods of material for use as a cortical bone modelImplants chirurgicaux Mthodes dessai des matriaux destins servir de modle dos corticalINTERNATIONAL STANDARDIS

6、O19213First edition2017-07Reference numberISO 19213:2017(E)BS ISO 19213:2017ISO 19213:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specified, no part of this publication may be reproduced or utilized otherw

7、ise 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 officeCh.

8、 de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgBS ISO 19213:2017ISO 19213:2017(E)ii ISO 2017 All rights reservedCOPYRIGHT PROTECTED DOCUMENT ISO 2017, Published in SwitzerlandAll rights reserved. Unless otherwise specifi

9、ed, no part of this publication may be reproduced or utilized 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

10、 member body in the country of the requester.ISO copyright officeCh. de Blandonnet 8 CP 401CH-1214 Vernier, Geneva, SwitzerlandTel. +41 22 749 01 11Fax +41 22 749 09 47copyrightiso.orgwww.iso.orgISO 19213:2017(E)Foreword vIntroduction vi1 Scope . 12 Normative references 13 Terms and definitions . 14

11、 Selection of test method . 24.1 General . 24.2 Fundamental tests 24.3 Practical tests . 25 Compressive test . 26 Tensile test 27 Hardness test 28 Charpy and Izod impact tests 29 Torque and axial pull-out test . 210 Diametral Tensile Strength (DTS) test . 210.1 Materials and apparatus . 310.1.1 Comp

12、ression testing machine 310.1.2 Compression tool . 310.1.3 Measuring instrument 310.2 Test specimen . 310.2.1 Shape and dimensions 310.2.2 Specimen inspection . 310.3 Anisotropic materials 410.4 Number of test specimens . 410.5 Test procedure . 410.5.1 Test specimen . 410.5.2 Test atmosphere . 410.5

13、.3 Setup . 410.6 Preload . 510.7 Recording of data 510.8 Calculation and expression of results 510.8.1 DTS . 510.8.2 Strain (as measured by extensometry) 610.8.3 Maximum strain 610.8.4 Statistical parameters 610.8.5 Test report . 611 Test method using ultrasonic bone cutting device (or ultrasonic su

14、rgical unit, instrument with an oscillating scalar tip) for cutting model . 711.1 Test method references . 711.2 Cutting under a constant feed rate or under a constant load . 711.3 Key terms . 711.3.1 Cutting depth 711.3.2 Cutting volume 711.4 Burning 711.5 Bounce-off . 711.6 Tip angle . 812 Test me

15、thod using a bone drill 812.1 Drilling test . 812.2 Position of drill to bone model surface 8 ISO 2017 All rights reserved iiiContents PageBS ISO 19213:2017ISO 19213:2017(E)12.3 Test report . 813 Final report 8Annex A (informative) Rationale 9Bibliography .14iv ISO 2017 All rights reservedBS ISO 192

16、13:2017ISO 19213:2017(E)12.3 Test report . 813 Final report 8Annex A (informative) Rationale 9Bibliography .14iv ISO 2017 All rights reserved ISO 19213:2017(E)ForewordISO (the International Organization for Standardization) is a worldwide federation of national standards bodies (ISO member bodies).

17、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-g

18、overnmental, 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 intended for its further maintenance are described

19、 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 www .iso .org/ directives).Attention is drawn to

20、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 will be in the Introduction and/or on the IS

21、O 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 voluntary nature of standards, the meaning of ISO specific terms and expressions

22、 related to conformity assessment, as well as information about ISOs adherence to the World Trade Organization (WTO) principles in the Technical Barriers to Trade (TBT) see the following URL: www .iso .org/ iso/ foreword .htmlThis document was prepared by Technical Committee ISO/TC 150, Implants for

23、 surgery, Subcommittee SC 5, Osteosynthesis and spinal devices. ISO 2017 All rights reserved vBS ISO 19213:2017ISO 19213:2017(E)IntroductionThis document details requirements for a set of mechanical test methods to evaluate material used as a cortical bone model. Bone models have long been used in m

24、echanical tests for devices or instruments such as those used in the orthopaedic surgery. The characteristics of the bone model, especially those of a cortical bone model, strongly influence the test results. Many devices and instruments are evaluated using bone models.Newer bone models are needed b

25、ecause conventional bone model properties change the primary outcome of interest such as failure mode. This results in devices not being evaluated correctly. Animal bones such as those from pigs are still used. However, animal bones have many sanitary problems and can introduce large errors (standar

26、d deviation). Recently, several new bone models have been introduced and standardized methods for evaluating these materials are required.This document introduces applicable standardized mechanical test methods for characterizing the material properties of cortical bone models. The mechanical proper

27、ties of the cortical bone itself such as tensile strength and compressive strength have been measured for some time, and several models have been produced based on the results. However, these fundamental mechanical properties do not strictly conform to the tactile feedback experienced by physicians.

28、 Material models have differences in tensile, compressive and shear strengths properties since they do not reproduce the complex anisotropic bone structure. For example, a material can be an excellent bone model based on tensile strength, but have significant differences in compressive and shear str

29、engths. Therefore, the model needs to be specific for the application to match the material properties as needed. This is because many kinds of fundamental properties are related in practical uses. Then, it is also necessary to perform practical tests of the bone model using devices and to show rela

30、tionships of mechanical characteristics between from fundamental tests and from practical tests.This document shows the relations and covers test methods for fundamental and practical tests. The final goal of this document is to facilitate the availability of good medical devices and instruments to

31、patients. The mechanical properties under practical tests can also be useful to produce models of training and lectures of new devices, informed consent for patients and performances of pre-operation or surgical planning.vi ISO 2017 All rights reservedBS ISO 19213:2017ISO 19213:2017(E)IntroductionTh

32、is document details requirements for a set of mechanical test methods to evaluate material used as a cortical bone model. Bone models have long been used in mechanical tests for devices or instruments such as those used in the orthopaedic surgery. The characteristics of the bone model, especially th

33、ose of a cortical bone model, strongly influence the test results. Many devices and instruments are evaluated using bone models.Newer bone models are needed because conventional bone model properties change the primary outcome of interest such as failure mode. This results in devices not being evalu

34、ated correctly. Animal bones such as those from pigs are still used. However, animal bones have many sanitary problems and can introduce large errors (standard deviation). Recently, several new bone models have been introduced and standardized methods for evaluating these materials are required.This

35、 document introduces applicable standardized mechanical test methods for characterizing the material properties of cortical bone models. The mechanical properties of the cortical bone itself such as tensile strength and compressive strength have been measured for some time, and several models have b

36、een produced based on the results. However, these fundamental mechanical properties do not strictly conform to the tactile feedback experienced by physicians. Material models have differences in tensile, compressive and shear strengths properties since they do not reproduce the complex anisotropic b

37、one structure. For example, a material can be an excellent bone model based on tensile strength, but have significant differences in compressive and shear strengths. Therefore, the model needs to be specific for the application to match the material properties as needed. This is because many kinds o

38、f fundamental properties are related in practical uses. Then, it is also necessary to perform practical tests of the bone model using devices and to show relationships of mechanical characteristics between from fundamental tests and from practical tests.This document shows the relations and covers t

39、est methods for fundamental and practical tests. The final goal of this document is to facilitate the availability of good medical devices and instruments to patients. The mechanical properties under practical tests can also be useful to produce models of training and lectures of new devices, inform

40、ed consent for patients and performances of pre-operation or surgical planning.vi ISO 2017 All rights reserved Implants for surgery Test methods of material for use as a cortical bone model1 ScopeThis document specifies mechanical test methods for characterizing cortical bone model materials for use

41、 as a standard model for performing mechanical tests for devices or instruments used in orthopaedic surgery, plastic surgery, neurosurgery, and oral and maxillofacial surgery. The document specifies static mechanical test and properties. Dynamic and viscoelastic/poroelastic tests and properties are

42、not included in the scope of this document.2 Normative referencesThe following documents are referred to in the text in such a way that some or all of their content constitute requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edit

43、ion of the referenced document (including any amendments) applies.ISO 179 (all parts), Plastics Determination of Charpy impact propertiesISO 180, Plastics Determination of Izod impact strengthISO 291, Plastics Standard atmospheres for conditioning and testingISO 527 (all parts), Plastics Determinati

44、on of tensile propertiesISO 604, Plastics Determination of compressive propertiesISO 2039-2, Plastics Determination of hardness Part 2: Rockwell hardnessISO 2602, Statistical interpretation of test results Estimation of the mean Confidence intervalISO 7500-1, Metallic materials Calibration and verif

45、ication of static uniaxial testing machines Part 1: Tension/compression testing machine Calibration and verification of the force-measuring systemISO 18397, Dentistry Powered scalerASTM D256, Standard Test Methods for Determining the Izod Pendulum Impact Resistance of PlasticsASTM D638, Standard Tes

46、t Method for Tensile Properties of PlasticsASTM D695, Standard Test Method for Compressive Properties of Rigid PlasticsASTM F543-07, Standard Specification and Test Methods for Metallic Medical Bone ScrewsJIS T 5750, Dentistry Dental Handpieces Ultrasonic Instruments And Tips For Multi-purpose Treat

47、ment3 Terms and definitionsFor the purposes of this document, the following terms and definitions apply.ISO and IEC maintain terminological databases for use in standardization at the following addresses: IEC Electropedia: available at h t t p :/ www .electropedia .org/ ISO Online browsing platform:

48、 available at h t t p :/ www .iso .org/ obpINTERNATIONAL STANDARD ISO 19213:2017(E) ISO 2017 All rights reserved 1BS ISO 19213:2017ISO 19213:2017(E)3.1cortical bone modelmaterial with the mechanical characteristics of cortical bone for performing mechanical tests for devices or instruments used in o

49、rthopaedic surgery, plastic surgery, neurosurgery, and oral and maxillofacial surgery4 Selection of test method4.1 GeneralMechanical test methods to evaluate cortical bone model materials are selected from tests for compressive strength, tensile strength, shear strength, hardness, Charpy and Izod impact, pull-out strength, strengths using ultrasonic or acoustic methods and drilling.Annex A provides rationale on the relation of the test methods in this document to the properties that