ASTM F561-04

Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues

SCOPE
1.1 This practice covers recommendations for the retrieval, handling, and analysis of implantable medical devices and associated specimens which are removed from patients, during revision surgery, at postmortem, or as part of animal studies. 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 E 860.
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.
This standard may involve hazardous materials, operations, and equipment. As a precautionary measure, removed implants 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 Information

• Status: Historical
• Publication Date: 30-Nov-2004
• ICS: 11.040.40 - Implants for surgery, prosthetics and orthotics
• Technical Committee: F04 - Medical and Surgical Materials and Devices
• Drafting Committee: F04.15 - Material Test Methods

Relations

• Replaces: ASTM F561-97(2003) - Practice for Retrieval and Analysis of Implanted Medical Devices, and Associated Tissues
• Effective Date: 01-Dec-2004
• Replaced By: ASTM F561-05 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 01-Jun-2005
• Referred By: ASTM F2979-20 - Standard Guide for Characterization of Wear from the Articulating Surfaces in Retrieved Metal-on-Metal and other Hard-on-Hard Hip Prostheses
• Effective Date: 01-Dec-2004
• Referred By: ASTM F1877-16 - Standard Practice for Characterization of Particles
• Effective Date: 01-Dec-2004
• Referred By: ASTM F3018-17 - Standard Guide for Assessment of Hard-on-Hard Articulation Total Hip Replacement and Hip Resurfacing Arthroplasty Devices
• Effective Date: 01-Dec-2004
• Referred By: ASTM F2694-16(2020) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• Effective Date: 01-Dec-2004
• Referred By: ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
• Effective Date: 01-Dec-2004
• Referred By: ASTM F3295-18 - Standard Guide for Impingement Testing of Total Disc Prostheses
• Effective Date: 01-Dec-2004
• Referred By: ASTM F3448-20 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
• Effective Date: 01-Dec-2004
• Referred By: ASTM F1875-98(2022) - Standard Practice for Fretting Corrosion Testing of Modular Implant Interfaces: Hip Femoral Head-Bore and Cone Taper Interface
• Effective Date: 01-Dec-2004
• Referred By: ASTM F3108-19 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
• Effective Date: 01-Dec-2004
• Referred By: ASTM F1904-23 - Standard Guide for Testing the Biological Responses to Medical Device Particulate Debris and Degradation Products <emph type="ital">in vivo</emph>
• Effective Date: 01-Dec-2004
• Referred By: ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• Effective Date: 01-Dec-2004
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Dec-2004
• Referred By: ASTM F2847-17 - Standard Practice for Reporting and Assessment of Residues on Single-Use Implants and Single-Use Sterile Instruments
• Effective Date: 01-Dec-2004

Standards Content (Sample)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
Contact ASTM International (www.astm.org) for the latest information
Designation:F561–04
Standard Practice for
Retrieval and Analysis of Implanted Medical Devices, and
1
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. A detailed discussion of precautions to be used in
associated specimens which are removed from patients, during
handling of human tissues can be found in ISO 12891-1. This
revision surgery, at postmortem, or as part of animal studies.
standard does not purport to address all of the safety concerns,
The aim is to provide guidance in preventing damage to the
if any, associated with its use. It is the responsibility of the user
associated specimens which could obscure the investigational
of this standard to establish appropriate safety and health
results, and in gathering data at the proper time and circum-
practices and determine the applicability of regulatory limita-
stance to validate the study.
tions prior to use.
1.2 This practice offers guidelines for the analysis of re-
trieved implants to limit damage to them, and to allow
2. Referenced Documents
comparisons between investigational results from different
2
2.1 ASTM Standards:
studies. The protocols are divided into three stages, where
A 262 Practices for Detecting Susceptibility to Intergranu-
Stage I is the minimum non-destructive analysis, Stage II is
lar Attack in Austenitic Stainless Steels
more complete non-destructive analysis, and Stage III is
A 751 Test Methods, Practices, and Terminology for
destructive analysis. Standard protocols for the examination
Chemical Analysis of Steel Products
and collection of data are provided for specific types of
C 20 Test Methods for Apparent Porosity, Water Absorp-
materials in relation to their typical applications. For particular
tion, Apparent Specific Gravity and Bulk Density of
investigational programs, additional, more specific, protocols
Burned Refractory Brick and Shapes by Boiling Water
mayberequired.Ifspecialanalyticaltechniquesareemployed,
C 158 Test Methods for Strength of Glass Flexure (Deter-
the appropriate handling procedures must be specified.
mination of Modulus of Rupture)
1.3 This practice recommendation should be applied in
C 169 Test Methods for Chemical Analysis of Soda-Lime
accordance with national regulations or legal requirements
and Borosilicate Glass
regarding the handling and analysis of retrieved implants and
C 573 Test Methods for Chemical Analysis of Fireclay and
excised tissues, especially with regard to handling devices
3
High-Alumina Refractories
which may become involved in litigation, as per Practice
C 623 Test Method for Young’s Modulus, Shear Modulus,
E 860.
and Poisson’s Ratio for Glass and Glass-Ceramics by
1.4 A significant portion of the information associated with
Resonance
aretrievedimplantdeviceisoftenatthedevice-tissueinterface
C 633 Test Method for Adhesion or Cohesion Strength of
or in the tissues associated with the implant and related organ
Thermal Sprayed Coatings
systems.Attention should be given to the handling of adjacent
C 674 Test Methods for Flexural Properties of Ceramic
tissues, so as not to interfere with study of the particles in the
Whiteware Materials
adjacent tissue, a chemical analysis for the byproducts of
C 730 Test Method for Knoop Indentation Hardness of
degradation of the implant, or a study of the cellular response
Glass
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 For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
F04.18 on Device Retrieval Analysis. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Dec. 1, 2004. Published December 2004. Originally the ASTM website.
3
approved 1978. Last previous edition approved in 2003 as F 561 – 97 (2003). Withdrawn.
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