ASTM F561-19
Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

Standard No.

ASTM F561-19

Release Date

2019

Published By

American Society for Testing and Materials (ASTM)

Latest

ASTM F561-19

Scope

1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from human and animal subjects during revision surgery and at postmortem. This practice may be used for the analysis of any implant including inert, bioactive, resorbable, and tissue engineered products. This practice can also be used for analysis of specimens and fluids from in vitro tests, including those from wear tests and joint simulators. The aim is to provide guidance to minimize iatrogenic damage during the recovery and handling of the associated specimens which could obscure the investigational results. This practice is also intended to provide guidance as to gathering data at the proper time and circumstance. 1.2 This 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. Note that regulations for handling of patient information, tissues, and retrieved devices will vary by geography. 1.3 This practice should be applied in accordance with pertinent regulations or legal requirements regarding the handling of patient data as well as the handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become involved in litigation, as in accordance with Practice E860. Note that regulations for handling of patient information, tissues, and retrieved devices will vary by geography 1.4 A 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. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

ASTM F561-19 Referenced Document

• ASTM A262 Standard Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
• ASTM A751 Standard Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
• ASTM C1069 Standard Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
• ASTM C1161 Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
• ASTM C1198 Standard Test Method for Dynamic Young's Modulus, Shear Modulus, and Poisson's Ratio for Advanced Ceramics by Sonic Resonance
• ASTM C1322 Standard Practice for Fractography and Characterization of Fracture Origins in Advanced Ceramics
• ASTM C1326 Standard Test Method for Knoop Indentation Hardness of Advanced Ceramics
• ASTM C1327 Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics
• ASTM C158 Standard Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
• ASTM C169 Standard Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
• ASTM C20 Standard Test Methods for Apparent Porosity, Water Absorption, Apparent Specific Gravity, and Bulk Density of Burned Refractory Brick and Shapes by Boiling Water*， 2022-02-01 Update
• ASTM C623 Standard Test Method for Young's Modulus, Shear Modulus, and Poisson's Ratio for Glass and Glass-Ceramics by Resonance
• ASTM C633 Standard Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings
• ASTM C674 Standard Test Methods for Flexural Properties of Ceramic Whiteware Materials
• ASTM C730 Standard Test Method for Knoop Indentation Hardness of Glass*， 2021-01-01 Update
• ASTM D1004 Standard Test Method for Initial Tear Resistance of Plastic Film and Sheeting
• ASTM D1238 Standard Test Method for Flow Rates of Thermoplastics by Extrusion Plastometer
• ASTM D1239 Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals
• ASTM D1505 Standard Test Method for Density of Plastics by the Density-Gradient Technique
• ASTM D1621 Standard Test Method for Compressive Properties of Rigid Cellular Plastics
• ASTM D1622 Standard Test Method for Apparent Density of Rigid Cellular Plastics
• ASTM D1623 Standard Test Method for Tensile And Tensile Adhesion Properties Of Rigid Cellular Plastics
• ASTM D1708 Standard Test Method for Tensile Properties of Plastics By Use of Microtensile Specimens
• ASTM D2240 Standard Test Method for Properties of Rubber &8212; Durometer Hardness*， 2024-04-20 Update
• ASTM D256 Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics*， 2023-03-15 Update
• ASTM D2842 Standard Test Method for Water Absorption of Rigid Cellular Plastics
• ASTM D2857 Standard Practice for Dilute Solution Viscosity of Polymers
• ASTM D2990 Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
• ASTM D3016 Standard Practice for Use of Liquid Exclusion Chromatography Terms and Relationships
• ASTM D3418 Standard Test Method for Transition Temperatures of Polymers By Differential Scanning Calorimetry
• ASTM D3835 Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
• ASTM D3919 Standard Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry
• ASTM D4000 Standard Classification System for Specifying Plastic Materials*， 2023-03-15 Update
• ASTM D4001 Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers By Light Scattering
• ASTM D4065 Standard Practice for Plastics: Dynamic Mechanical Properties: Determination and Report of Procedures
• ASTM D412 Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers8212;Tension
• ASTM D4754 Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
• ASTM D5227 Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins
• ASTM D5296 Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
• ASTM D624 Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers*， 2024-04-20 Update
• ASTM D638 Standard Test Method for Tensile Properties of Plastics
• ASTM D695 Standard Test Method for Compressive Properties of Rigid Plastics
• ASTM D732 Standard Test Method for Shear Strength of Plastics by Punch Tool
• ASTM D747 Standard Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam
• ASTM D785 Standard Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials
• ASTM D790 Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials*， 2024-04-20 Update
• ASTM D792 Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
• ASTM E10 Standard Test Method for Brinell Hardness of Metallic Materials*， 2023-08-03 Update
• ASTM E112 Standard Test Methods for Determining Average Grain Size
• ASTM E1188 Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator
• ASTM E135 Standard Terminology Relating to Analytical Chemistry for Metals, Ores, and Related Materials
• ASTM E1479 Standard Practice for Describing and Specifying Inductively-Coupled Plasma Atomic Emission Spectrometers
• ASTM E18 Standard Test Methods for Rockwell Hardness of Metallic Materials*， 2022-05-01 Update
• ASTM E2451 Standard Practice for Preserving Ignitable Liquids and Ignitable Liquid Residue Extracts from Fire Debris Samples*， 2021-09-01 Update
• ASTM E3 Standard Practice for Preparation of Metallographic Specimens
• ASTM E353 Standard Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys
• ASTM E354 Standard Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and Cobalt Alloys
• ASTM E407 Standard Practice for Microetching Metals and Alloys
• ASTM E45 Standard Test Methods for Determining the Inclusion Content of Steel
• ASTM E539 Standard Test Method for X-Ray Emission Spectrometric Analysis of 6AI-4V Titanium Alloy
• ASTM E562 Standard Test Method for Determining Volume Fraction by Systematic Manual Point Count
• ASTM E7 Standard Terminology Relating to Metallography*， 2022-10-01 Update
• ASTM E8 Standard Test Methods for Tension Testing of Metallic Materials
• ASTM E860 Standard Practice for Examining And Preparing Items That Are Or May Become Involved In Criminal or Civil Litigation
• ASTM E883 Standard Guide for Reflected-Light Photomicrography
• ASTM E92 Standard Test Method for Vickers Hardness of Metallic Materials
• ASTM E986 Standard Practice for Scanning Electron Microscope Beam Size Characterization
• ASTM F1044 Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings
• ASTM F1147 Standard Test Method for Tension Testing of Calcium Phosphate and Metal Coatings
• ASTM F1635 Standard Test Method for In Vitro Degradation Testing of Poly (L-lactic Acid) Resin and Fabricated Form for Surgical Implants
• ASTM F1854 Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
• ASTM F1877 Standard Practice for Characterization of Particles
• ASTM F2102 Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
• ASTM F2182 Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging*， 2019-09-15 Update
• ASTM F2214 Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)*， 2023-09-01 Update
• ASTM F2502 Standard Specification and Test Methods for Absorbable Plates and Screws for Internal Fixation Implants
• ASTM F2739 Standard Guide for Quantifying Cell Viability and Related Attributes within Biomaterial Scaffolds*， 2019-09-01 Update
• ASTM F2977 Standard Test Method for Small Punch Testing of Polymeric Biomaterials Used in Surgical Implants*， 2020-04-01 Update
• ASTM F2979 Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses*， 2020-12-15 Update
• ASTM F2995 Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids*， 2024-01-15 Update
• ASTM F3036 Standard Guide for Testing Absorbable Stents*， 2021-11-01 Update
• ASTM F3129 Standard Guide for Characterization of Material Loss from Conical Taper Junctions in Total Joint Prostheses*， 2024-04-20 Update
• ASTM F316 Standard Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test*， 2019-11-01 Update
• ASTM F619 Standard Practice for Extraction of Medical Plastics
• ASTM F981 Standard Practice for Assessment of Compatibility of Biomaterials for Surgical Implants with Respect to Effect of Materials on Muscle and Bone

ASTM F561-19 history

• 2019 ASTM F561-19 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• 2013 ASTM F561-13 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• 2005 ASTM F561-05a(2010) Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• 2005 ASTM F561-05a Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• 2005 ASTM F561-05 Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• 2004 ASTM F561-04 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
• 1997 ASTM F561-97(2003) Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
• 1997 ASTM F561-97 Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues