• ASTM F 561 : 2013

    Superseded A superseded Standard is one, which is fully replaced by another Standard, which is a new edition of the same Standard.
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    Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

    Available format(s):  Hardcopy, PDF

    Superseded date:  02-14-2019

    Language(s):  English

    Published date:  09-01-2013

    Publisher:  American Society for Testing and Materials

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    Abstract - (Show below) - (Hide below)

    This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from patients during revision surgery, at postmortem, or as part of animal studies.

    Scope - (Show below) - (Hide below)

    1.1This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from patients during revision surgery, at postmortem, or as part of animal studies. This practice can also be used for analysis of specimens and lubrication fluids from in vitro wear tests and joint simulators. The aim is to provide guidance in preventing damage to the associated specimens which could obscure the investigational results, and in gathering data at the proper time and circumstance to validate the study.

    1.2This practice offers guidelines for the analysis of retrieved implants to limit damage to them, and to allow comparisons between investigational results from different studies. The protocols are divided into three stages, where Stage I is the minimum non-destructive analysis, Stage II is more complete non-destructive analysis, and Stage III is destructive analysis. Standard protocols for the examination and collection of data are provided for specific types of materials in relation to their typical applications. For particular investigational programs, additional, more specific, protocols may be required. If special analytical techniques are employed, the appropriate handling procedures must be specified.

    1.3This practice recommendation should be applied in accordance with national regulations or legal requirements regarding the handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become involved in litigation, as per Practice E860.

    1.4A significant portion of the information associated with a retrieved implant device is often at the device-tissue interface or in the tissues associated with the implant and related organ systems. Attention should be given to the handling of adjacent tissues, so as not to interfere with study of the particles in the adjacent tissue, a chemical analysis for the byproducts of degradation of the implant, or a study of the cellular response to the implant.

    1.5The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.

    1.6This standard may involve hazardous materials, operations, and equipment. As a precautionary measure, explanted devices should be sterilized or minimally disinfected by an appropriate means that does not adversely affect the implant or the associated tissue that may be subject to subsequent analysis. A detailed discussion of precautions to be used in handling of human tissues can be found in ISO 12891-1. This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety and health practices and determine the applicability of regulatory limitations prior to use.

    General Product Information - (Show below) - (Hide below)

    Committee F 04
    Document Type Standard Practice
    Publisher American Society for Testing and Materials
    Status Superseded
    Superseded By
    Supersedes

    Standards Referenced By This Book - (Show below) - (Hide below)

    ASTM F 1983 : 2014 : REDLINE Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
    ASTM F 2624 : 2012 : R2016 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
    ASTM F 1877 : 2016 : REDLINE Standard Practice for Characterization of Particles
    ASTM F 2789 : 2010 : R2015 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
    ASTM F 2721 : 2009 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
    ASTM F 2624 : 2012 Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
    10/30195943 DC : 0 BS ISO 12891-1 - IMPLANTS FOR SURGERY - RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 1: RETRIEVAL AND HANDLING
    BS ISO 12891-1:2015 RETRIEVAL AND ANALYSIS OF SURGICAL IMPLANTS - PART 1: RETRIEVAL AND HANDLING
    ASTM F 2979 : 2014 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
    ASTM F 982 : 1986 : R1998 Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion
    ASTM F 2789 : 201 Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
    ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1: Retrieval and handling
    ASTM F 1875 : 1998 : R2009 Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
    ASTM F 1875 : 1998 Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
    ASTM F 3129 : 2016 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses
    ASTM F 2884 : 2012 Standard Guide for Pre-clinical in vivo Evaluation of Spinal Fusion (Withdrawn 2021)
    ASTM F 3037 : 2015 Standard Guide for Clinical Trial Design for Hip Replacement Systems (HRSs) (Withdrawn 2020)
    ASTM F 2423 : 2011 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
    ASTM F 2721 : 2009 : R2014 Standard Guide for Pre-clinical in vivo Evaluation in Critical Size Segmental Bone Defects
    NBR 15670-4 : 2009 ORTHOPEDICS IMPLANTS - MODULAR ORTHOPEDIC PROSTHESES - PART 4: PRACTICE FOR FRETTING CORROSION TESTING OF MODULAR INTERFACES: HIP FEMORAL HEAD-BORE AND CONE TAPER INTERFACE
    ASTM F 1875 : 1998 : R2014 Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
    ASTM F 2694 : 2016 : REDLINE Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
    ASTM F 2423 : 2011 : R2016 Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
    ASTM F 982 : 1986 : R2008 Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion (Withdrawn 2017)
    ASTM F 3018 : 2017 Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
    ASTM F 982 : 1986 : R2002 Standard Specification for Disclosure of Characteristics of Surgically Implanted Clamps for Carotid Occlusion
    ASTM F 2451 : 2005 : R2010 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage (Withdrawn 2019)
    ASTM F 1904 : 2014 : REDLINE Standard Practice for Testing the Biological Responses to Particles in vivo
    ASTM F 2451 : 2005 Standard Guide for in vivo Assessment of Implantable Devices Intended to Repair or Regenerate Articular Cartilage
    ASTM F 1875 : 1998 : R2004 Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-bore and Cone Taper Interface
    ASTM F 2847 : 2017 : REDLINE Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments

    Standards Referencing This Book - (Show below) - (Hide below)

    ASTM D 2857 : 2016 Standard Practice for Dilute Solution Viscosity of Polymers
    ASTM F 1877 : 2016 : REDLINE Standard Practice for Characterization of Particles
    ASTM D 3418 : 2015 : REDLINE Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
    ASTM D 671 : 1993 Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
    ASTM A 262 : 2015 : REDLINE Standard Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
    ASTM D 4001 : 2013 : REDLINE Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering
    ASTM E 7 : 2017 : REDLINE Standard Terminology Relating to Metallography
    ASTM D 732 : 2017 : REDLINE Standard Test Method for Shear Strength of Plastics by Punch Tool
    ASTM E 562 : 2011 : REDLINE Standard Test Method for Determining Volume Fraction by Systematic Manual Point Count
    ASTM D 1623 : 2017 : REDLINE Standard Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
    ASTM D 5227 : 2013 : REDLINE Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins
    ASTM D 1238 : 2013 : REDLINE Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer
    ASTM D 1004 : 2013 : REDLINE Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting
    ASTM E 120 : 2000 Standard Test Methods for Chemical Analysis of Titanium and Titanium Alloys (Withdrawn 2003)
    ASTM D 792 : 2013 : REDLINE Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
    ASTM D 1239 : 2014 : REDLINE Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
    ASTM D 5296 : 2011 : REDLINE Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
    ASTM C 1327 : 2015 : REDLINE TEST METHOD FOR VICKERS INDENTATION HARDNESS OF ADVANCED CERAMICS
    ASTM E 10 : 2017-05 TEST METHOD FOR BRINELL HARDNESS OF METALLIC MATERIALS
    ASTM E 1479 : 2016 : REDLINE Standard Practice for Describing and Specifying Inductively Coupled Plasma Atomic Emission Spectrometers
    ASTM C 1322 : 2015 : REDLINE PRACTICE FOR FRACTOGRAPHY AND CHARACTERIZATION OF FRACTURE ORIGINS IN ADVANCED CERAMICS
    ASTM E 204 : 1998 Standard Practices for Identification of Material by Infrared Absorption Spectroscopy, Using the ASTM Coded Band and Chemical Classification Index
    ASTM E 353 : 2014 : REDLINE Standard Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys
    ASTM C 158 : 2002 Standard Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
    ASTM D 5152 : 1991 Practice for Water Extraction of Residual Solids from Degraded Plastics for Toxicity Testing (Withdrawn 1998)
    ASTM F 619 : 2014 : REDLINE Standard Practice for Extraction of Medical Plastics
    ASTM F 2214 : 2016 : REDLINE Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
    ASTM D 790 : 2017 : REDLINE Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
    ASTM F 2995 : 2013 Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
    ASTM F 2102 : 2017 : REDLINE Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
    ASTM C 169 : 2016 : REDLINE Standard Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
    ASTM D 3835 : 2016 : REDLINE Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
    ASTM D 4065 : 2012 : REDLINE Standard Practice for Plastics: Dynamic Mechanical Properties: Determination and Report of Procedures
    ASTM D 1242 : 1995 : REV A Standard Test Methods for Resistance of Plastic Materials to Abrasion (Withdrawn 2004)
    ASTM E 8 : 2004 Standard Test Methods for Tension Testing of Metallic Materials
    ASTM E 290 : 2014 : REDLINE Standard Test Methods for Bend Testing of Material for Ductility
    ASTM D 1621 : 2016 : REDLINE Standard Test Method for Compressive Properties of Rigid Cellular Plastics
    ASTM D 695 : 2015 : REDLINE Standard Test Method for Compressive Properties of Rigid Plastics
    ASTM D 570 : 1998 : R2018 Standard Test Method for Water Absorption of Plastics
    ASTM D 2990 : 2017 : REDLINE Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
    ASTM D 638 : 2014 : REDLINE Standard Test Method for Tensile Properties of Plastics
    ISO 12891-1:2015 Retrieval and analysis of surgical implants Part 1: Retrieval and handling
    ASTM E 354 : 2014 : REDLINE Standard Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and Cobalt Alloys
    ASTM F 1854 : 2015 : REDLINE Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
    ASTM E 92 : 2017 : REDLINE Standard Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
    ASTM D 4000 : 2016 : REDLINE Standard Classification System for Specifying Plastic Materials
    ASTM E 168 : 2016 Standard Practices for General Techniques of Infrared Quantitative Analysis
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