1、Designation:F284710Standard Practice forReporting and Assessment of Residues on Single UseImplants1This 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
2、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 propos
3、es 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
4、 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
5、for thegeneral specification of residues and residue requirements ofimplants.This practice may also be used to characterizesemi-finished components for implants.1.6 The test methods suggested and described herein refer toestablished analytical methods and to existing standard meth-ods for chemical,b
6、iochemical,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
7、 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 and health practices and determine the applica-bility of regulatory
8、 limitations prior to use.2.Referenced Documents2.1 ASTM Standards:2E996 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 I
9、on 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 Biolog
10、ical 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 GravimetricAnalys
11、isF2809 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 byUltrasonic TechniquesG136 Practice for Determination of Soluble Residua
12、l Con-taminants in Materials by Ultrasonic Extraction2.2 ISO Standards:4ISO 10993-1 Biological Evaluation of Medical DevicesPart 1:Evaluation and TestingISO 10993-17 Biological Evaluation of Medical Devices1This practice is under the jurisdiction ofASTM Committee F04 on Medical andSurgical Materials
13、 and Devices and is the direct responsibility of SubcommitteeF04.15 on Material Test Methods.Current edition approved Dec.1,2010.Published January 2011.DOI:10.1520/F284710.2For referenced ASTM standards,visit the ASTM website,www.astm.org,orcontact ASTM Customer Service at serviceastm.org.For Annual
14、 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.4Available from American National Standards Institute(ANSI),25 W.43rd St.,4th Floor,New York,NY 10036,http:/ww
15、w.ansi.org.Copyright ASTM International,100 Barr Harbor Drive,PO Box C700,West Conshohocken,PA 19428-2959.United States1 Part 17:Establishment of Allowable Limits for LeachableSubstancesISO 10993-18 Biological Evaluation of Medical DevicesPart 18:Chemical Characterization of MaterialsISO11737-1 Ster
16、ilizationofMedicalDevicesMicrobiological MethodsPart 1:Determination of aPopulation of Microorganisms on Products2.3 United States Pharmacopeia(USP)Document:5 Bacterial Endotoxin Test2.4 European Pharmacopoeia(PhEUR)Documents:62.2.23 Atomic Absorption Spectrometry2.2.24 Absorption Spectrophotometry,Infrared2.2.25 Absorption Spectrophotometry,Ultraviolet and Vis-ible2.2.28 Gas Chromatography2.2.29 Liquid Chromatography2.2.43 Mass Spectrometry2.2.44 Total Organic Carbon in Water for Pharmaceutical
