ASTM F561-97(2003)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation:F561–97 (Reapproved 2003)
Practice for
Retrieval and Analysis of Implanted Medical Devices, and
Associated Tissues
This standard is issued under the fixed designation F 561; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision. A number in parentheses indicates the year of last reapproval. A
superscript epsilon (e) indicates an editorial change since the last revision or reapproval.
1. Scope implants should be sterilized or minimally disinfected by an
appropriate means that does not adversely affect the implant or
1.1 This practice covers recommendations for the retrieval,
the associated tissue that may be subject to subsequent
handling, and analysis of implantable medical devices and
analysis. This standard does not purport to address all of the
associated specimens which are removed from patients, during
safety concerns, if any, associated with its use. It is the
revision surgery, at postmortem, or as part of animal studies.
responsibility of the user of this standard to establish appro-
The aim is to provide guidance in preventing damage to the
priate safety and health practices and determine the applica-
associated specimens which could obscure the investigational
bility of regulatory limitations prior to use.
results, and in gathering data at the proper time and circum-
stance to validate the study.
2. Referenced Documents
1.2 This practice offers guidelines for the analysis of re-
2.1 ASTM Standards:
trieved implants to limit damage to them, and to allow
A 262 Practices for Detecting Susceptibility to Intergranu-
comparisons between investigational results from different
lar Attack in Austenitic Stainless Steels
studies. The protocols are divided into three stages, where
A 751 Test Methods, Practices, and Terminology for
Stage I is the minimum non-destructive analysis, Stage II is
Chemical Analysis of Steel Products
more complete non-destructive analysis, and Stage III is
C 20 Test Methods for Apparent Porosity, Water Absorp-
destructive analysis. Standard protocols for the examination
tion, Apparent Specific Gravity and Bulk Density of
and collection of data are provided for specific types of
Burned Refractory Brick and Shapes by Boiling Water
materials in relation to their typical applications. For particular
C 158 Test Methods for Strength of Glass Flexure (Deter-
investigational programs, additional, more specific, protocols
mination of Modulus of Rupture)
may be required. If special analytical techniques are employed,
C 169 Test Methods for Chemical Analysis of Soda-Lime
the appropriate handling procedures must be specified.
and Borosilicate Glass
1.3 This practice recommendation should be applied in
C 573 Test Methods for Chemical Analysis of Fireclay and
accordance with national regulations or legal requirements
High-Alumina Refractories
regarding the handling and analysis of retrieved implants and
C 623 Test Method for Young’s Modulus, Shear Modulus,
excised tissues, especially with regard to handling devices
and Poisson’s Ratio for Glass and Glass-Ceramics by
which may become involved in litigation, as per Practice
Resonance
E 860.
C 633 Test Method for Adhesion or Cohesion Strength of
1.4 A significant portion of the information associated with
Thermal Sprayed Coatings
aretrievedimplantdeviceisoftenatthedevice-tissueinterface
C 674 Test Methods for Flexural Properties of Ceramic
or in the tissues associated with the implant and related organ
Whiteware Materials
systems.Attention should be given to the handling of adjacent
C 730 Test Method for Knoop Indentation Hardness of
tissues, so as not to interfere with study of the particles in the
Glass
adjacent tissue, a chemical analysis for the byproducts of
C 849 Test Method for Knoop Indentation Hardness of
degradation of the implant, or a study of the cellular response
Ceramic Whitewares
to the implant.
C 1069 Test Method for Specific Surface Area of Alumina
1.5 This standard may involve hazardous materials, opera-
or Quartz by Nitrogen Adsorption
tions, and equipment. As a precautionary measure, removed
1 2
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland Annual Book of ASTM Standards, Vol 01.03.
Surgical Materials and Devices and is the direct responsibility of Subcommittee Annual Book of ASTM Standards, Vol 15.01.
F04.18 on Device Retrieval Analysis. Annual Book of ASTM Standards, Vol 15.02.
Current edition approved Apr. 10, 2003. Published May 2003. Originally Discontinued—See 1994 Annual Book of ASTM Standards, Vol 03.05.
approved 1978. Last previous edition approved in 1997 as F 561 – 97. Annual Book of ASTM Standards, Vol 02.05.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F561–97 (2003)
C 1161 Test Method for Flexural Strength—Advanced Ce- D 2857 Test Method for Dilute Solution Viscosity of Poly-
3 9
ramics at Ambient Temperatures mers
C 1198 Test Method for Dynamic Young’s Modulus, Shear D 2873 Test Method for Interior Porosity of Poly(Vinyl
Modulus, and Poisson’s Ratio for Advanced Ceramics by Chloride) (PVC) Resins by Mercury Intrusion Porosim-
3 9
Sonic Resonance etry
D 256 Test Methods for Determining the Izod Pendulum D 2990 Test Methods for Tensile, Compressive, and Flex-
7 9
Impact Resistance of Plastics ural Creep and Creep-Rupture of Plastics
D 412 Test Methods for Vulcanized Rubber and Thermo- D 3016 Practice for Use of Liquid Exclusion Chromatogra-
7 9
plastic Elastomers-Tension phy Terms and Relationships
D 570 Test Method for Water Absorption of Plastics D 3417 Test Methods for Heats of Fusion and Crystalliza-
D 621 Test Methods for Deformation of Plastics Under tion of Polymers by Thermal Analysis
Load D 3418 Test Method for Transition Temperatures of Poly-
D 624 Test methods for Tear Strength of Conventional mers by Thermal Analysis
Vulcanized Rubber and Thermoplastic Elastomers D 3835 Test Method for Determination of Properties of
7 9
D 638 Test Method for Tensile Properties of Plastics Polymeric Materials by Means of a Capillary Rheometer
D 671 Test Method for Flexural Fatigue of Plastics by D 3919 Practice for Measuring Trace Elements in Water by
7 10
Constant Amplitude of Force GraphiteFurnaceAtomicAbsorptionSpectrophotometry
D 695 Test Method for Compressive Properties of Rigid D 4000 Classification System for Specifying Plastic Mate-
7 9
Plastics rials
D 732 Test Method for Shear Strength of Plastics by Punch D 4001 Test Method for Determination of Weight-Average
7 11
Tool Molecular Weight by Light Scattering
D 747 Test Method for Apparent Bending Modulus of D 4065 Practice for Determining and Reporting Dynamic
7 9
Plastics by Means of a Cantilever Beam Mechanical Properties of Plastics
D 785 Test Method for Rockwell Hardness of Plastics and D 4754 Test Method for Two-Sided Liquid Extraction of
7 11
Electrical Insulating Materials Plastic Materials Using FDA Migration Cell
D 790 TestMethodsforFlexuralPropertiesofUnreinforced D 5152 Practice for Water Extraction of Residual Solids
and Reinforced Plastics and Electrical Insulating Materi- from Degraded Plastics for Toxicity Testing
als D 5227 Test Method for the Measurement of Hexane Ex-
D 792 TestMethodsforDensityandSpecificGravity(Rela- tractable Content of Polyolefins
tive Density) of Plastics by Displacement D 5296 Test Method for Molecular Weight Averages and
D 1004 Test Method for Initial Tear Resistance of Plastic Molecular Weight Distribution of Polystyrenbe b Hugh
7 9
Film and Sheeting Performance Size-Exclusion Chromatography
D 1042 Test Method for Linear Dimensional Changes of E 3 Methods of Preparation of Metallographic Specimens
7 12
Plastics Under Accelerated Service Conditions E 7 Terminology Relating to Metallography
D 1238 Test Method for Flow Rates of Thermoplastics by E 8 Test Methods for Tension Testing of Metallic Materi-
7 12
Extrusion Plastometer als
D 1239 Test Method for Resistance of Plastic Films to E 10 Test Method for Brinell Hardness of Metallic Materi-
7 12
Extraction by Chemicals als
D 1242 Test Methods for Resistance of Plastic Materials to E 18 Test Methods for Rockwell Hardness and Rockwell
7 12
Abrasion Superficial Hardness of Metallic Materials
D 1505 Test Method for Density of Plastics by the E 45 Test Methods for Determining the Inclusion Content
7 12
Density—Gradient Technique of Steel
D 1621 Test Method for Compressive Properties of Rigid E 92 Test Method for Vickers Hardness of Metallic Mate-
7 12
Cellular Plastics rials
D 1622 Test Method forApparent Density of Rigid Cellular E 112 Test Methods for Determining the Average Grain
7 12
Plastics Size
D 1623 Test Method for Tensile and Tensile Adhesion E 120 Test Methods for ChemicalAnalysis of Titanium and
7 13
Properties of Rigid Cellular Plastics Titanium Alloys
D 1708 Test Method for Tensile Properties of Plastics by E 135 Terminology Relating to Analytical Chemistry for
7 13
Use of Micro Tensile Specimens Metals, Ores, and Related Materials
D 2240 Test Method for Rubber Property—Durometer E 168 Practices for General Techniques of Infrared Quanti-
7 14
Hardness tative Analysis
D 2842 Test Method forWaterAbsorbtion of Rigid Cellular
Plastics
Annual Book of ASTM Standards, Vol 11.01.
Annual Book of ASTM Standards, Vol 08.03.
7 12
Annual Book of ASTM Standards, Vol 08.01. Annual Book of ASTM Standards, Vol 03.01.
8 13
Annual Book of ASTM Standards, Vol 09.01. Annual Book of ASTM Standards, Vol 03.05.
9 14
Annual Book of ASTM Standards, Vol 08.02. Annual Book of ASTM Standards, Vol 03.06.
F561–97 (2003)
E 204 Practices for Identification of Materials by Infrared 3.1.1 antiseptic—a germicide that is used on skin or living
Absorption Spectroscopy Using the ASTM Coded Band tissue for the purposes of inhibiting or destroying microorgan-
and Chemical Classification Index isms.
E 290 Test Method for Bend Testing of Material for Duc- 3.1.2 decontamination—a process or treatment that renders
tility a medical device, instrument, or environmental surface safe to
E 353 Test Methods for Chemical Analysis of Stainless, handle. Ranges from sterilization to cleaning with soap and
Heat-Resisting, Maraging, and Other Similar Chromium- water.
Nickel-Iron Alloys 3.1.3 disinfectant—a germicide that is used solely for de-
E 354 Test Methods for Chemical Analysis of High- stroying microorganisms on inanimate objects.
Temperature, Electrical, Magnetic, and Other Similar Iron, 3.1.4 disinfection—generally less lethal than sterilization. It
Nickel, and Cobalt Alloys eliminates virtually all recognized pathogenic microorganisms
E 386 Practice for Data Presentation Relating to High but not necessarily all microbial forms (for example, bacterial
Resolution Nuclear Magnetic Resonance (NMR) Spectros- endospores) on inanimate objects. It does not ensure overkill.
copy 3.1.5 sterilization—use of a physical or chemical procedure
E 407 Practice for Microetching of Metals and Alloys to destroy all microbial life; including large numbers of highly
E 562 Practice for Determining Volume Fraction by Sys- resistant bacterial endospores.
tematic Manual Point Count
4. Summary of Practice
E 663 Practice for Flame Atomic Absorption Spectros-
4.1 This practice provides recommendations for collection
copy
E 860 Practice for Examining and Testing Items that are or of clinical data, analysis of adjacent tissues, and the material
characterizations to be performed when an implant is retrieved
May Become Involved in Products Liability Litigation
E 883 Guide for Reflected-Light Photomicrography as part of a clinical or an animal study.
4.2 The clinical data to be recorded include a case history
E 986 Practice for Scanning Electron Microscope Beam
review, roentgenogram reviews, tissue culture, and observa-
Size Characterization
tions of the implant site.
E 1188 Practice for Collection and Preservation of Informa-
4.3 Protocols are provided for the handling of the implant
tion and Physical Items by a Technical Investigator
tissue interface, and adjacent tissues for subsequent analysis.
E 1452 Practice for Preparation of Calibration Solutions for
These protocols are intended to facilitate (a) histologic and
Spectrophotometric and for Spectroscopic Atomic Analy-
immunohistochemical examination of the tissues, (b) chemical
ses
analysis of the tissues for identification and quantification of
E 1479 Practice for Describing and Specifying Inductively-
implant corrosion or degradation products, and (c) digestion of
Coupled Plasma Optical Emission Spectrophotometers
tissues for subsequent harvesting and analysis of particulate
F 316 Test Method for Pore Size Characteristics of Mem-
debris.
brane Filters for Use with Aerospace Fluids
4.4 The material characterizations include observation and
F 619 Practice for Extraction of Medical Plastics
description of the explanted device and adjacent tissues,
F 981 Practice for Assessment of Compatibility of Bioma-
determination of chemical composition, macroscopic and mi-
terials for Surgical Implants with Respect to Effect of
croscopic examinations and mechanical property determina-
Materials on Muscle and Bone
tions. The guidelines are separated in three stages. Stage I is
F 1044 Test Method for Shear Testing of Porous Metal
considered to comprise an essential minimum analysis for
Coatings
routine examination of all types of materials. Stage II is
F 1147 Test Method for Tension Testing of Porous Metal
nondestructive but provides more detail and is intended for
Coatings
special studies of devices with or without impaired function,
F 1501 Test Method for Tension Testing of Calcium Phos-
made of all types of materials. Stage III includes destructive
phate Coatings
methodsforandmaterial-specificprotocolsfordetailedfailure,
F 1658 Test Method for Shear Testing of Calcium Phos-
microstructural,andchemicalanalysisaswellasdetermination
phate Coatings
of physical and mechanical properties.
2.2 Other Document:
ISO/DIS 12891-1, Retrieval and Analysis of Implantable
5. Significance and Use
Medical Devices, Part 1: Standard Practice for Retrieval
5.1 The investigation of retrieved implantable medical de-
and Handling
vices and adjacent tissues can be of value in the assessment of
clinical complications associated with the use of a specific
3. Terminology
prosthetic device design; can expand the knowledge of clinical
3.1 Definition of Terms Specific to Issues of Microbial
implantperformanceandinteractionsbetweenimplantsandthe
Contamination:
body; provide information on implant performance and safety;
and thus further the development of biocompatibl
...