ASTM_F_2943_-_14.pdf

Designation:F294314Standard Guide forPresentation of End User Labeling Information forMusculoskeletal Implants1This standard is issued under the fixed designation F2943;the number immediately following the designation indicates the year oforiginal adoption or,in 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 The goal of this guide is to recommend a universal labelformat(across manufacturers and various implants)of contentand relative location of information necessary for final implantselection within an implants overall package labeling.1.2 This guide recommends package labeling for musculo-skeletal based implants individually processed and packagedwith the intent of being opened at the point of use,typically inthe operating room.1.3 This guide identifies the necessary,“high priority”labelcontent and recommendations for the layout and location ofinformation for accurate implant identification by the end usersin the operating room environment.1.4 This goal is achieved by creating a partitioned,second-ary area of an implants package label or a separate label topresent this information uniformly.1.5 The authors of this guide identified the competing needsof regulatory requirements,manufacturing/distribution,andimplant identification.It is recognized through our task groupsefforts that,if a manufacturer elects to implement theserecommendations,balancing these competing needs may ne-cessitate changing a manufacturers internal processes,relabel-ing their entire inventory(either at a single point in time orover a defined time period),or accepting duplicate informationon an implants package label.No additional compromises thatwould allow the primary goal of uniform implant label designacross manufacturers were identified.1.6 It is not the intent of this guide to limit or dictate overallpackage labeling content.1.7 It is not the intent of this guide to supplant existingregulatory requirements(only to augment or complementexisting regulatory label requirements).1.8 The use or application of multiple languages is notprevented by this guide;however,use of more than onelanguage is discouraged on the implant selection sublabel(ISSL)defined in this guide.The language of choice is left tothe manufacturer and should be dictated by the end user andregulatory requirements in the jurisdictions where the device ismarketed.International symbols should also be considered toavoid the need for multiple ISSLs where possible.1.9 Use and implementation of this guide is optional and atthe sole discretion of the implants manufacturer.It shall beimplemented with the following considerations:1.9.1 The content and layout of any orthopedic implantlabel should be influenced by risk management activities andall label formats should be validated.1.9.2 If internal risk management activities recommenddeviation from this guide,the manufacturer is discouragedfrom implementing a hybrid label that partially applies theprinciples and recommendations in this guide.1.10 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.11 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.Referenced Documents2.1 ISO Standards:2ISO 13485 MedicalDevicesQualityManagementSystemsRequirements for Regulatory PurposesISO 152231 Medical DevicesSymbols to be Used withMedical Device Labels,Labeling and Information to beSuppliedPart 1:General Requirements3.Terminology3.1 Definitions:3.1.1 body side,adjimplants that are right/left specific andfor which side of the body they are intended.1This guide is under the jurisdiction of ASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.22 on Arthroplasty.Current edition approved April 1,2014.Published June 2014.Originallyapproved in 2013.Last previous edition approved in 2013 as F294313.DOI:10.1520/F2943-14.2Available 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.United States1 3.1.1.1 DiscussionThis may also include identifiers formedial/lateral or anterior/posterior.3.1.2 company,nthe business that is primarily responsiblefor providing the product to the end user.3.1.2.1 DiscussionIt is preferred that this is reflective ofthe company designation that will be commonly used by theend user to identify the implant.3.1.3 end of the box(EOB),nthe surface of an implantspackaging that is most commonly visible when the product isplaced in inventory/storage(see Fig.1).3.1.3.