ASTM_F_2847_-_17.pdf

Designation:F284717Standard Practice forReporting and Assessment of Residues on Single-UseImplants and Single-Use Sterile Instruments1This standard is issued under the fixed designation F2847;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 purpose of this practice is to describe how thecleanliness of single-use implants as manufactured shall bereported.This practice proposes how to approach the identifi-cation of critical compounds and suggests different analyticalmethods.1.2 The practice does not address substances which areintrinsic to the implant properties or design.In particular,itdoes not address substances released during implant resorption,implant coatings,or leachables by design.1.3 This practice does not address the cleanliness of im-plants which are re-processed,re-cleaned after unpacking forre-use in the hospital or by the manufacturer.1.4 This practice does not establish limit values for residues.1.5 This practice suggests appropriate test methods for thegeneral specification of residues and residue requirements ofimplants and single-use sterile instruments.This practice mayalso be used to characterize semi-finished components forimplants.1.6 The test methods suggested and described herein refer toestablished analytical methods and to existing standard meth-ods for chemical,biochemical,or biological analysis.1.7 This practice is intended solely to provide guidanceregarding suitable test methods and reporting conventions forresidues,which may or may not affect implant biocompatibil-ity.This practice does not suggest or recommend test methodsfor biocompatibility,which may be found in Practice F748 orin ISO 10993-1.1.8 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,health,and environmental practices and deter-mine the applicability of regulatory limitations prior to use.1.9 This international standard was developed in accor-dance with internationally recognized principles on standard-ization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recom-mendations issued by the World Trade Organization TechnicalBarriers to Trade(TBT)Committee.2.Referenced Documents2.1 ASTM Standards:2E29 Practice for Using Significant Digits in Test Data toDetermine Conformance with SpecificationsE996 Practice for Reporting Data in Auger Electron Spec-troscopy and X-ray Photoelectron SpectroscopyE1078 Guide for Specimen Preparation and Mounting inSurface AnalysisE1504 Practice for Reporting Mass Spectral Data in Second-ary Ion Mass Spectrometry(SIMS)E1635 Practice for Reporting Imaging Data in SecondaryIon Mass Spectrometry(SIMS)E1829 Guide for Handling Specimens Prior to SurfaceAnalysisF561 Practice for Retrieval and Analysis of MedicalDevices,and Associated Tissues and FluidsF748 Practice for Selecting Generic Biological Test Methodsfor Materials and DevicesF1251 Terminology Relating to Polymeric Biomaterials inMedical and Surgical Devices(Withdrawn 2012)3F1877 Practice for Characterization of ParticlesF2459 Test Method for Extracting Residue from MetallicMedical Components and Quantifying via GravimetricAnalysisF2809 Terminology Relating to Medical and Surgical Mate-rials and DevicesG121 Practice for Preparation of Contaminated Test Cou-pons for the Evaluation of Cleaning AgentsG131 Practice for Cleaning of Materials and Components by1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Sept.15,2017.Published October 2017.Originallyapproved in 2010.Last previous edition approved in 2010 as F2847 10.DOI:10.1520/F2847-17.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual Book of ASTMStandards volume information,refer to the standards Document Summary page onthe ASTM website.3The last approved version of this historical standard is referenced onwww.astm.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United StatesThis international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for theDevelopment of International Standards,Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade(TBT)Committee.1 Ultrasonic TechniquesG136 Practice for Determination of Soluble Residual Con-taminants in Materials by Ultrasonic Extraction2.2 ISO Standards:4ISO 10993-1 Biological Evaluation of M