ASTM_F_561_-_13.pdf

Designation:F56113Standard Practice forRetrieval and Analysis of Medical Devices,and AssociatedTissues and Fluids1This standard is issued under the fixed designation F561;the number immediately following the designation indicates the year of originaladoption or,in the case of revision,the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscriptepsilon()indicates an editorial change since the last revision or reapproval.1.Scope1.1 This practice covers recommendations for the retrieval,handling,and analysis of implanted medical devices andassociated specimens that are removed from patients duringrevision surgery,at postmortem,or as part of animal studies.This practice can also be used for analysis of specimens andlubrication fluids from in vitro wear tests and joint simulators.The aim is to provide guidance in preventing damage to theassociated specimens which could obscure the investigationalresults,and in gathering data at the proper time and circum-stance to validate the study.1.2 This practice offers guidelines for the analysis of re-trieved implants to limit damage to them,and to allowcomparisons between investigational results from differentstudies.The protocols are divided into three stages,whereStage I is the minimum non-destructive analysis,Stage II ismore complete non-destructive analysis,and Stage III isdestructive analysis.Standard protocols for the examinationand collection of data are provided for specific types ofmaterials in relation to their typical applications.For particularinvestigational programs,additional,more specific,protocolsmay be required.If special analytical techniques are employed,the appropriate handling procedures must be specified.1.3 This practice recommendation should be applied inaccordance with national regulations or legal requirementsregarding the handling and analysis of retrieved implants andexcised tissues,especially with regard to handling deviceswhich may become involved in litigation,as per Practice E860.1.4 A significant portion of the information associated witha retrieved implant device is often at the device-tissue interfaceor in the tissues associated with the implant and related organsystems.Attention should be given to the handling of adjacenttissues,so as not to interfere with study of the particles in theadjacent tissue,a chemical analysis for the byproducts ofdegradation of the implant,or a study of the cellular responseto the implant.1.5 The values stated in SI units are to be regarded asstandard.No other units of measurement are included in thisstandard.1.6 This standard may involve hazardous materials,operations,and equipment.As a precautionary measure,ex-planted devices should be sterilized or minimally disinfected byan appropriate means that does not adversely affect theimplant or the associated tissue that may be subject tosubsequent analysis.A detailed discussion of precautions to beused in handling of human tissues can be found in ISO12891-1.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 ASTM Standards:2A262 Practices for Detecting Susceptibility to IntergranularAttack in Austenitic Stainless SteelsA751 Test Methods,Practices,and Terminology for Chemi-cal Analysis of Steel ProductsC20 Test Methods for Apparent Porosity,Water Absorption,Apparent Specific Gravity,and Bulk Density of BurnedRefractory Brick and Shapes by Boiling WaterC158 Test Methods for Strength of Glass by Flexure(De-termination of Modulus of Rupture)C169 Test Methods for Chemical Analysis of Soda-Limeand Borosilicate GlassC573 Methods for Chemical Analysis of Fireclay and High-Alumina Refractories(Withdrawn 1995)3C623 Test Method for Youngs Modulus,Shear Modulus,1This 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.1,2013.Published October 2013.Originallyapproved 1978.Last previous edition approved in 2010 as F561 05a(2010).DOI:10.1520/F0561-132For 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 States1 and Poissons Ratio for Glass and Glass-Ceramics byResonanceC633 Test Method for Adhesion or Cohesion Strength ofThermal Spray CoatingsC674 Test Methods for Flexural Properties of CeramicWhiteware MaterialsC730 Test Method for Knoop Indentation Hardness of GlassC1069 Test