1、Designation:F310714Standard Test Method forMeasuring Accuracy after Mechanical Disturbances onReference Frames of Computer Assisted Surgery Systems1This standard is issued under the fixed designation F3107;the number immediately following the designation indicates the year oforiginal adoption or,in
2、the case of revision,the year of last revision.A number in parentheses indicates the year of last reapproval.Asuperscript epsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This standard will measure the effects on the accuracy ofcomputer assisted surgery(CAS)sys
3、tems of the environmentalinfluences caused by equipment utilized for bone preparationduring the intended clinical application for the system.Theenvironmental vibration effect covered in this standard willinclude mechanical vibration from:Cutting saw(sagittal orreciprocating),Burrs,drills and impact
4、loading.The change inaccuracy from detaching and re-attaching,or disturbing arestrained connection that does not by design require repeatingthe registration process of a reference base will also bemeasured.1.2 It should be noted that one system may need to undergomultiple iterations(one for each cli
5、nical application)of thisstandard to document its accuracy during different clinicalapplications since each procedure may have different exposureto outside forces given the surgical procedure variability fromone procedure to the next.1.3 All units of measure will be reported as millimeters forthis s
6、tandard.1.4 This standard does not purport to address all of thesafety concerns,if any,associated with its use.It is theresponsibility of the user of this standard to establish appro-priate safety and health practices and determine the applica-bility of regulatory limitations prior to use.2.Referenc
7、ed Documents2.1 ASTM Standards:2E456 Terminology Relating to Quality and StatisticsE691 Practice for Conducting an Interlaboratory Study toDetermine the Precision of a Test MethodF2554 Practice for Measurement of Positional Accuracy ofComputer Assisted Surgical Systems2.2 ISO Standard:3ISO 10360 Geo
8、metrical Product Specifications(GPS)Acceptance and re-verification tests for coordinate mea-suring machines(CMM)3.Terminology3.1 Definition of Terms Specific to Accuracy Reporting:3.1.1 accuracy,nthe closeness of agreement between ameasurement result and an accepted reference value.E4563.1.1.1 Discu
9、ssionThe term accuracy,when applied to aset of measurement results,involves a combination of arandom component and of a common systematic error or biascomponent.3.1.2 bias,nthe difference between the expectation of themeasurement results and an accepted reference value.E4563.1.2.1 DiscussionBias is
10、the total systematic error ascontrasted to random error.There may be one or moresystematic error components contributing to the bias.A largersystematic difference from the accepted reference value isreflected by a larger bias value.3.1.3 maximum error,nthe largest distance between anymeasured point
11、and its corresponding reference position forany trial during a testing procedure.3.1.4 mean,nthe arithmetic mean(or simply the mean)ofa list of numbers is the sum of all the members of the listdivided by the number of items in the list.If one particularnumber occurs more times than others in the lis
12、t,it is called amode.The arithmetic mean is what students are taught veryearly to call the“average”.If the list is a statistical population,then the mean of that population is called a population mean.If the list is a statistical sample,we call the resulting statistic asample mean.3.1.5 measurement
13、range,nsee measurement volume.3.1.6 precision,nthe closeness of agreement betweenindependent measurement results obtained under stipulatedconditions.E4561This test method is under the jurisdiction ofASTM Committee F04 on Medicaland Surgical Materials and Devices and is the direct responsibility of S
14、ubcommitteeF04.38 on Computer Assisted Orthopaedic Surgical Systems.Current edition approved Dec.1,2014.Published January 2015.DOI:10.1520/F3107-14.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards v
15、olume information,refer to the standards Document Summary page onthe ASTM website.3Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/www.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.Un
16、ited States1 3.1.6.1 DiscussionPrecision depends on random errorsand does not relate to the true value or the specified value.Themeasure of precision usually is expressed in terms of impreci-sion and computed as a standard deviation of the test results.3.1.6.2 DiscussionLess precision is reflected by a largerstandard deviation.“Independent test results”means resultsobtained in a manner not influenced by any previous result onthe same or similar test object.Quantitative measures ofprecision depen
