ASTM F561-13

Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids

STANDARD published on 1.9.2013

Language
Format	PDF - Immediate download - 83.00 USD Print design - 83.00 USD
Availability	IN STOCK
Price	83.00 USD excl. VAT
83.00 USD

The information about the standard:

Designation standards: ASTM F561-13
Note: WITHDRAWN
Publication date standards: 1.9.2013
SKU: NS-55728
The number of pages: 20
Approximate weight : 60 g (0.13 lbs)
Country: American technical standard
Category: Technical standards ASTM

Send to a colleague

Query

The category - similar standards:

Implants for surgery, prosthetics and orthotics

Annotation of standard text ASTM F561-13 :

Keywords:
ceramics, chemical analysis, composites, histology, implant retrieval, metals, particles, polymers, ICS Number Code 11.040.40 (Implants for surgery, prothetics and orthotics)

Additional information

Significance and Use

5.1 The investigation of retrieved implantable medical devices and adjacent tissues can be of value in the assessment of clinical complications associated with the use of a specific prosthetic device design; can expand the knowledge of clinical implant performance and interactions between implants and the body; provide information on implant performance and safety; and thus further the development of biocompatible implant materials and devices with improved performance. Comparison of wear patterns and wear particle morphology observed with retrievals and those observed with in vitro joint simulator tests can provide valuable insight into the validity of the 5.2 A significant portion of the information associated with a retrieved implant is obtained with detailed studies of the device-tissue interface. Appropriate methods are provided to facilitate a study of the particles in the tissues, and chemical analysis for the byproducts of degradation of the implant, and histologic evaluation of the cellular response to the implant.

5.3 For the analysis to be accurate, it is essential that the device and associated tissues be removed without alteration of their form and structure. It is also essential that the tissues be handled in such a way as to avoid microbial contamination of the work place or the investigator. Standard protocols for the examination and collection of data are provided for retrieval and handling of implantable medical devices, as well as 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 procedures must be specified.

5.4 In order to interpret the analysis of materials and tissues, it is also essential to capture a minimum data set regarding the clinical findings and laboratory studies documenting device performance and reasons for removal.

5.5 Any destructive analysis of implants must be done so as to not destroy any features that may become the subject of litigation, as per Practice E860. This standard recommendation should be applied in accordance with state or national regulations or legal requirements regarding the handling and analysis of retrieved implants and tissues.

1. Scope

1.1 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. 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.

1.2 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.

1.3 This 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.

1.4 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 and health practices and determine the applicability of regulatory limitations prior to use.

2. Referenced Documents

C169-16(2022)	Standard Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
C573-81	Methods for Chemical Analysis of Fireclay and High-Alumina Refractories (Withdrawn 1993)
C623-21	Standard Test Method for Young's Modulus, Shear Modulus, and Poisson's Ratio for Glass and Glass-Ceramics by Resonance
E168-16(2023)	Standard Practices for General Techniques of Infrared Quantitative Analysis
E204-98	Standard Practices for Identification of Material by Infrared Absorption Spectroscopy, Using the ASTM Coded Band and Chemical Classification Index
E290-22	Standard Test Methods for Bend Testing of Material for Ductility
E353-19e1	Standard Test Methods for Chemical Analysis of Stainless, Heat-Resisting, Maraging, and Other Similar Chromium-Nickel-Iron Alloys (Includes all amendments and changes 2/23/2022).
E354-21e1	Standard Test Methods for Chemical Analysis of High-Temperature, Electrical, Magnetic, and Other Similar Iron, Nickel, and Cobalt Alloys (Includes all amendments and changes 2/23/2022).
E386-90(1999)	Standard Practice for Data Presentation Relating to High-Resolution Nuclear Magnetic Resonance (NMR) Spectroscopy
E1188-23	Standard Practice for Collection and Preservation of Information and Physical Items by a Technical Investigator
E1479-16	Standard Practice for Describing and Specifying Inductively Coupled Plasma Atomic Emission Spectrometers
F316-03(2019)	Standard Test Methods for Pore Size Characteristics of Membrane Filters by Bubble Point and Mean Flow Pore Test
F619-20	Standard Practice for Extraction of Materials Used in Medical Devices
F981-23	Standard Practice for Assessment of Muscle and Bone Tissue Responses to Long-Term Implantable Materials Used in Medical Devices
F1044-05(2017)e1	Standard Test Method for Shear Testing of Calcium Phosphate Coatings and Metallic Coatings (Includes all amendments and changes 1/11/2018).
F2102-17	Standard Guide for Evaluating the Extent of Oxidation in Polyethylene Fabricated Forms Intended for Surgical Implants
F2182-19e2	Standard Test Method for Measurement of Radio Frequency Induced Heating On or Near Passive Implants During Magnetic Resonance Imaging (Includes all amendments and changes 4/7/2020).
D1622-20	Standard Test Method for Apparent Density of Rigid Cellular Plastics
D1042-22	Standard Test Method for Linear Dimensional Changes of Plastics Caused by Exposure to Heat and Moisture
D1238-23a	Standard Test Method for Melt Flow Rates of Thermoplastics by Extrusion Plastometer (Includes all amendments and changes 12/6/2023).
D1239-22a	Standard Test Method for Resistance of Plastic Films to Extraction by Chemicals (Includes all amendments and changes 9/12/2022).
D1242-95a	Standard Test Methods for Resistance of Plastic Materials to Abrasion (Withdrawn 2004)
D1505-18	Standard Test Method for Density of Plastics by the Density-Gradient Technique
D1621-16(2023)	Standard Test Method for Compressive Properties of Rigid Cellular Plastics
C730-98(2021)	Standard Test Method for Knoop Indentation Hardness of Glass
C674-13(2023)	Standard Test Methods for Flexural Properties of Ceramic Whiteware Materials
C1069-09(2022)	Standard Test Method for Specific Surface Area of Alumina or Quartz by Nitrogen Adsorption
C1161-18(2023)	Standard Test Method for Flexural Strength of Advanced Ceramics at Ambient Temperature
C1198-20	Standard Test Method for Dynamic Young´s Modulus, Shear Modulus, and Poisson´s Ratio for Advanced Ceramics by Sonic Resonance
C1322-15(2019)	Standard Practice for Fractography and Characterization of Fracture Origins in Advanced Ceramics
C1326-13(2023)	Standard Test Method for Knoop Indentation Hardness of Advanced Ceramics
C1327-15(2019)	Standard Test Method for Vickers Indentation Hardness of Advanced Ceramics
D256-23e1	Standard Test Methods for Determining the Izod Pendulum Impact Resistance of Plastics (Includes all amendments and changes 4/7/2023).
D570-22	Standard Test Method for Water Absorption of Plastics
D621-64(1988)	Test Methods for Deformation of Plastics Under Load (Withdrawn 1994)
D624-00(2020)	Standard Test Method for Tear Strength of Conventional Vulcanized Rubber and Thermoplastic Elastomers
D638-22	Standard Test Method for Tensile Properties of Plastics
D671-93	Standard Test Method for Flexural Fatigue of Plastics by Constant-Amplitude-of-Force (Withdrawn 2002)
D695-23	Standard Test Method for Compressive Properties of Rigid Plastics
D732-17	Standard Test Method for Shear Strength of Plastics by Punch Tool
D747-10	Standard Test Method for Apparent Bending Modulus of Plastics by Means of a Cantilever Beam (Withdrawn 2019)
D785-23	Standard Test Method for Rockwell Hardness of Plastics and Electrical Insulating Materials
D790-17	Standard Test Methods for Flexural Properties of Unreinforced and Reinforced Plastics and Electrical Insulating Materials
D792-20	Standard Test Methods for Density and Specific Gravity (Relative Density) of Plastics by Displacement
D1004-21	Standard Test Method for Tear Resistance (Graves Tear) of Plastic Film and Sheeting
A262-15(2021)	Standard Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
C20-00(2022)	Standard Test Methods for Apparent Porosity, Water Absorption, Apparent Specific Gravity, and Bulk Density of Burned Refractory Brick and Shapes by Boiling Water
C633-13(2021)	Standard Test Method for Adhesion or Cohesion Strength of Thermal Spray Coatings
E407-23	Standard Practice for Microetching Metals and Alloys
E562-19e1	Standard Test Method for Determining Volume Fraction by Systematic Manual Point Count (Includes all amendments and changes 8/24/2020).
E663-86(1991)E01	Practice for Flame Atomic Absorption Analysis (Withdrawn 1997)
E860-22	Standard Practice for Examining and Preparing Items That Are or May Become Involved in Criminal or Civil Litigation
E883-11(2017)	Standard Guide for Reflected-Light Photomicrography
E986-04(2017)	Standard Practice for Scanning Electron Microscope Beam Size Characterization
F1147-05(2017)e1	Standard Test Method for Tension Testing of Calcium Phosphate and Metallic Coatings (Includes all amendments and changes 6/17/2022).
F1854-15	Standard Test Method for Stereological Evaluation of Porous Coatings on Medical Implants
F1877-16	Standard Practice for Characterization of Particles
ISO 12891-1,	Retrieval and Analysis of Implantable Medical Devices, Part 1: Standard Practice for Retrieval and Handling
F2214-23	Standard Test Method for In Situ Determination of Network Parameters of Crosslinked Ultra High Molecular Weight Polyethylene (UHMWPE)
F2995-24	Standard Guide for Shipping Possibly Infectious Materials, Tissues, and Fluids
A751-21	Standard Test Methods and Practices for Chemical Analysis of Steel Products
C158-23	Standard Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
D412-16(2021)	Standard Test Methods for Vulcanized Rubber and Thermoplastic Elastomers—Tension
D1708-18	Standard Test Method for Tensile Properties of Plastics by Use of Microtensile Specimens
D2240-15(2021)	Standard Test Method for Rubber Property—Durometer Hardness
D2857-22	Standard Practice for Dilute Solution Viscosity of Polymers
D2873-94(1999)e1	Standard Test Method for Interior Porosity of Poly(Vinyl Chloride) (PVC) Resins by Mercury Intrusion Porosimetry (Withdrawn 2003)
D2990-17	Standard Test Methods for Tensile, Compressive, and Flexural Creep and Creep-Rupture of Plastics
D3016-97(2018)	Standard Practice for Use of Liquid Exclusion Chromatography Terms and Relationships
E3-11(2017)	Standard Guide for Preparation of Metallographic Specimens
E7-22	Standard Terminology Relating to Metallography
E8-04	Standard Test Methods for Tension Testing of Metallic Materials
E10-23	Standard Test Method for Brinell Hardness of Metallic Materials
E120-00	Standard Test Methods for Chemical Analysis of Titanium and Titanium Alloys (Withdrawn 2003)
D1623-17(2023)	Standard Test Method for Tensile and Tensile Adhesion Properties of Rigid Cellular Plastics
D2842-19	Standard Test Method for Water Absorption of Rigid Cellular Plastics
D3417-99	Standard Test Method for Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry (DSC) (Withdrawn 2004)
D3418-21	Standard Test Method for Transition Temperatures and Enthalpies of Fusion and Crystallization of Polymers by Differential Scanning Calorimetry
D3835-16	Standard Test Method for Determination of Properties of Polymeric Materials by Means of a Capillary Rheometer
D3919-15	Standard Practice for Measuring Trace Elements in Water by Graphite Furnace Atomic Absorption Spectrophotometry
D4000-23	Standard Classification System for Specifying Plastic Materials
D4001-20	Standard Test Method for Determination of Weight-Average Molecular Weight of Polymers by Light Scattering
D4065-20	Standard Practice for Plastics: Dynamic Mechanical Properties: Determination and Report of Procedures
D4754-18	Standard Test Method for Two-Sided Liquid Extraction of Plastic Materials Using FDA Migration Cell
D5152-91	Practice for Water Extraction of Residual Solids from Degraded Plastics for Toxicity Testing (Withdrawn 1998)
D5227-21	Standard Test Method for Measurement of Hexane Extractable Content of Polyolefins
D5296-19	Standard Test Method for Molecular Weight Averages and Molecular Weight Distribution of Polystyrene by High Performance Size-Exclusion Chromatography
E18-22	Standard Test Methods for Rockwell Hardness of Metallic Materials
E45-18a(2023)	Standard Test Methods for Determining the Inclusion Content of Steel (Includes all amendments and changes 11/6/2023).
E92-23	Standard Test Methods for Vickers Hardness and Knoop Hardness of Metallic Materials
E112-13(2021)	Standard Test Methods for Determining Average Grain Size
E135-23a	Standard Terminology Relating to Analytical Chemistry for Metals, Ores, and Related Materials (Includes all amendments and changes 7/17/2023).