ASTM F561-97

NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
Designation: F 561 – 97
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 appropriate means that does not adversely affect the implant or
the associated tissue that may be subject to subsequent
1.1 This practice covers recommendations for the retrieval,
analysis. This standard does not purport to address all of the
handling, and analysis of implantable medical devices and
safety concerns, if any, associated with its use. It is the
associated specimens which are removed from patients, during
responsibility of the user of this standard to establish appro-
revision surgery, at postmortem, or as part of animal studies.
priate safety and health practices and determine the applica-
The aim is to provide guidance in preventing damage to the
bility of regulatory limitations prior to use.
associated specimens which could obscure the investigational
results, and in gathering data at the proper time and circum-
2. Referenced Documents
stance to validate the study.
2.1 ASTM Standards:
1.2 This practice offers guidelines for the analysis of re-
A 262 Practices for Detecting Susceptibility to Intergranu-
trieved implants to limit damage to them, and to allow
lar Attack in Austenitic Stainless Steels
comparisons between investigational results from different
A 751 Test Methods, Practices and Terminology for Chemi-
studies. The protocols are divided into three stages, where
cal Analysis of Steel Products
Stage I is the minimum non-destructive analysis, Stage II is
C 20 Test Methods for Apparent Porosity, Water Absorp-
more complete non-destructive analysis, and Stage III is
tion, Apparent Specific Gravity and Bulk Density of
destructive analysis. Standard protocols for the examination
Burned Refractory Brick and Shapes by Boiling Water
and collection of data are provided for specific types of
C 158 Test Methods for Strength of Glass (Determination of
materials in relation to their typical applications. For particular
Modulus of Rupture)
investigational programs, additional, more specific, protocols
C 169 Test Methods for Chemical Analysis of Soda-Lime
may be required. If special analytical techniques are employed,
and Borosilicate Glass
the appropriate handling procedures must be specified.
C 573 Test Methods for Chemical Analysis of Fireclay and
1.3 This practice recommendation should be applied in
High-Alumina Refractories
accordance with national regulations or legal requirements
C 623 Test Method for Young’s Modulus, Shear Modulus,
regarding the handling and analysis of retrieved implants and
and Poisson’s ratio for Glass and Glass-Ceramics by
excised tissues, especially with regard to handling devices
Resonance
which may become involved in litigation, as per Practice
C 633 Test Method for Adhesion or Cohesive Strength of
E 860.
Flame-Sprayed Coatings
1.4 A significant portion of the information associated with
C 674 Test Methods for Flexural Properties of Ceramic
a retrieved implant device is often at the device-tissue interface
White Ware Materials
or in the tissues associated with the implant and related organ
C 730 Test Method for Knoop Indentation Hardness of
systems. Attention should be given to the handling of adjacent
Glass
tissues, so as not to interfere with study of the particles in the
C 849 Test Method for Knoop Indentation Hardness of
adjacent tissue, a chemical analysis for the byproducts of
Ceramic Whitewares
degradation of the implant, or a study of the cellular response
C 1069 Test Method for Specific Surface Area of Alumina
to the implant.
or Quartz by Nitrogen Adsorption
1.5 This standard may involve hazardous materials, opera-
C 1161 Test Method for Flexural Strength—Advanced Ce-
tions, and equipment. As a precautionary measure, removed
ramics at Ambient Temperatures
implants should be sterilized or minimally disinfected by an
C 1198 Test Method for Dynamic Young’s Modulus, Shear
1 2
This practice is under the jurisdiction of ASTM Committee F-4 on Medical and 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 Dec. 10, 1997. Published June 1998. Originally Discontinued—See 1994 Annual Book of ASTM Standards, Vol 03.05.
published as F 561 – 78. Last previous edition F 561 – 87 (1994). Annual Book of ASTM Standards, Vol 02.05.
Copyright © ASTM, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 561
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
Constant Amplitude of Force Graphite Furnace Atomic Absorption Spectrophotometry
D 695 Test Method for Compressive Properties of Rigid
D 4000 Classification System for Specifying Plastic Mate-
Plastics rials
D 732 Test Method for Shear Strength of Plastics by Punch
D 4001 Test Method for Determination of Weight-Average
Tool Molecular Weight by Light Scattering
D 747 Test Method for Apparent Bending Modulus of
D 4065 Practice for Determining and Reporting Dynamic
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
Electrical Insulating Materials
Plastic Materials Using FDA Migration Cell
D 790 Test Methods for Flexural Properties of Unreinforced
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 Test Methods for Density and Specific Gravity (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
Film and Sheeting
Performance Size-Exclusion Chromatography
D 1042 Test Method for Linear Dimensional Changes of
E 3 Methods of Preparation of Metallographic Specimens
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-
Extrusion Plastometer
als
D 1239 Test Method for Resistance of Plastic Films to
E 10 Test Method for Brinell Hardness of Metallic Materi-
Extraction by Chemicals
als
D 1242 Test Methods for Resistance of Plastic Materials to
E 18 Test Methods for Rockwell Hardness and Rockwell
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
Density—Gradient Technique
of Steel
D 1621 Test Method for Compressive Properties of Rigid
E 92 Test Method for Vickers Hardness of Metallic Mate-
Cellular Plastics
rials
D 1622 Test Method for Apparent Density of Rigid Cellular
E 112 Test Methods for Determining the Average Grain
Plastics
Size
D 1623 Test Method for Tensile and Tensile Adhesion
E 120 Test Methods for Chemical Analysis of Titanium and
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
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-
Hardness
tative Analysis
D 2842 Test Method for Water Absorbtion of Rigid Cellular
E 204 Practices for Identification of Materials by Infrared
Plastics
Absorption Spectroscopy Using the ASTM Coded Band
D 2857 Test Method for Dilute Solution Viscosity of Poly-
and Chemical Classification Index
mers
D 2873 Test Method for Interior Porosity of Poly(Vinyl
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.
NOTICE: This standard has either been superceded and replaced by a new version or discontinued.
Contact ASTM International (www.astm.org) for the latest information.
F 561
E 290 Test Method for Bend Testing of Material for Duc- a medical device, instrument, or environmental surface safe to
tility handle. Ranges from sterilization to cleaning with soap and
E 353 Test Methods for Chemical Analysis of Stainless, water.
Heat-Resisting, Maraging, and Other Similar Chromium- 3.1.3 disinfectant—a germicide that is used solely for de-
Nickel-Iron Alloys stroying microorganisms on inanimate objects.
E 354 Test Methods for Chemical Analysis of High- 3.1.4 disinfection—generally less lethal than sterilization. It
Temperature, Electrical, Magnetic, and Other Similar Iron, eliminates virtually all recognized pathogenic microorganisms
Nickel, and Cobalt Alloys but not necessarily all microbial forms (e.g., bacterial en-
E 386 Practice for Data Presentation Relating to High dospores) on inanimate objects. It does not insure overkill.
Resolution Nuclear Magnetic Resonance (NMR) Spectros- 3.1.5 sterilization—use of a physical or chemical procedure
copy to destroy all microbial life; including large numbers of highly
E 407 Practice for Microetching of Metals and Alloys resistant bacterial endospores.
E 562 Practice for Determining Volume Fraction by Sys-
12 4. Summary of Practice
tematic Manual Point Count
4.1 This practice provides recommendations for collection
E 663 Practice for Flame Atomic Absorption Spectros-
of clinical data, analysis of adjacent tissues and the material
copy
characterizations to be performed when an implant is retrieved
E 860 Practice for Examining and Testing Items that are or
as part of a clinical or an animal study.
May Become Involved in Products Liability Litigation
4.2 The clinical data to be recorded include a case history
E 883 Guide for Reflected-Light Photomicrography
E 986 Practice for Scanning Electron Microscope Beam review, roentgenogram reviews, tissue culture, and observa-
tions of the implant site.
Size Characterization
E 1188 Practice for Collection and Preservation of Informa- 4.3 Protocols are provided for the handling of the implant
tissue interface, and adjacent tissues for subsequent analysis.
tion and Physical Items by a Technical Investigator
E 1452 Practice for Preparation of Calibration Solutions for These protocols are intended to facilitate (a) histologic and
immunohistochemical examination of the tissues, (b) chemical
Spectrophotometric and for Spectroscopic Atomic Analy-
ses analysis of the tissues for identification and quantification of
implant corrosion or degradation products, and (c) digestion of
E 1479 Practice for Describing and Specifying Inductively-
tissues for subsequent harvesting and analysis of particulate
Coupled Plasma Optical Emission Spectrophotometers
debris.
F 316 Test Method for Pore Size Characteristics of Mem-
4.4 The material characterizations include observation and
brane Filters for Use with Aerospace Fluids
description of the explanted device and adjacent tissues,
F 619 Practice for Extraction of Medical Plastics
determination of chemical composition, macroscopic and mi-
F 981 Assessment of Compatibility of Biomaterials for
croscopic examinations and mechanical property determina-
Surgical Implants with Respect to Effect of Materials on
tions. The guidelines are separated in three stages. Stage I is
Muscle and Bone
considered to comprise an essential minimum analysis for
F 1044 Test Method for Shear Testing of Porous Metal
routine examination of all types of materials. Stage II is
Coatings
nondestructive but provides more detail and is intended for
F 1147 Test Method for Tension Testing of Porous Metal
special studies of devices with or without impaired function,
Coatings
made of all types of materials. Stage III includes destructive
F 1501 Test Method for Tension Testing of Calcium Phos-
methods for and material-specific protocols for detailed failure,
phate Coatings
F 1658 Test Method for Shear Testing of Calcium Phos- microstructural, and chemical analysis as well as determination
of physical and mechanical properties.
phate Coatings
2.2 Other Document:
5. Significance and Use
ISO/DIS 12891-1, Retrieval and Analysis of Implantable
5.1 The investigation of retrieved implantable medical de-
Medical Devices, Part 1: Standard Practice for Retrieval
vices and adjacent tissues can be of value in the assessment of
and Handling
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 implant performance and interactions between implants and t
...