ASTM F561-05a

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

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 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.
1.5 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-Sep-2005
• 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 F561-05 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 01-Oct-2005
• Replaced By: ASTM F561-05a(2010) - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 01-Sep-2010
• Referred By: ASTM F2083-21 - Standard Specification for Knee Replacement Prosthesis (Withdrawn 2023)
• Effective Date: 01-Oct-2005
• Referred By: ASTM F1983-23 - Standard Practice for Assessment of Selected Tissue Effects of Absorbable Biomaterials for Implant Applications
• Effective Date: 01-Oct-2005
• 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-Oct-2005
• Referred By: ASTM F1877-16 - Standard Practice for Characterization of Particles
• Effective Date: 01-Oct-2005
• Referred By: ASTM F2721-09(2023) - Standard Guide for Preclinical <emph type="ital">in vivo</emph> Evaluation in Critical-Size Segmental Bone Defects
• Effective Date: 01-Oct-2005
• 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-Oct-2005
• 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-Oct-2005
• 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-Oct-2005
• Referred By: ASTM F2665-21 - Standard Specification for Total Ankle Replacement Prosthesis
• Effective Date: 01-Oct-2005
• Referred By: ASTM F3448-20 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
• Effective Date: 01-Oct-2005
• Referred By: ASTM F3108-19 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
• Effective Date: 01-Oct-2005
• Referred By: ASTM F3295-18 - Standard Guide for Impingement Testing of Total Disc Prostheses
• Effective Date: 01-Oct-2005
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Oct-2005

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:F561–05a
Standard Practice for
Retrieval and Analysis of Medical Devices, and Associated
1
Tissues and Fluids
ThisstandardisissuedunderthefixeddesignationF561;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoptionor,inthecaseofrevision,theyearoflastrevision.Anumberinparenthesesindicatestheyearoflastreapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope 1.5 This standard may involve hazardous materials, opera-
tions, and equipment. As a precautionary measure, explanted
1.1 This practice covers recommendations for the retrieval,
devices should be sterilized or minimally disinfected by an
handling, and analysis of implanted medical devices and
appropriate means that does not adversely affect the implant or
associated specimens that are removed from patients during
the associated tissue that may be subject to subsequent
revision surgery, at postmortem, or as part of animal studies.
analysis. A detailed discussion of precautions to be used in
This practice can also be used for analysis of specimens and
handling of human tissues can be found in ISO 12891-1. This
lubrication fluids from in vitro wear tests and joint simulators.
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
A262 Practices for Detecting Susceptibility to Intergranular
Stage I is the minimum non-destructive analysis, Stage II is
Attack in Austenitic Stainless Steels
more complete non-destructive analysis, and Stage III is
A751 TestMethods,Practices,andTerminologyforChemi-
destructive analysis. Standard protocols for the examination
cal Analysis of Steel Products
and collection of data are provided for specific types of
C20 TestMethodsforApparentPorosity,WaterAbsorption,
materialsinrelationtotheirtypicalapplications.Forparticular
Apparent Specific Gravity, and Bulk Density of Burned
investigational programs, additional, more specific, protocols
Refractory Brick and Shapes by Boiling Water
mayberequired.Ifspecialanalyticaltechniquesareemployed,
C158 Test Methods for Strength of Glass by Flexure (De-
the appropriate handling procedures must be specified.
termination of Modulus of Rupture)
1.3 This practice recommendation should be applied in
C169 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
C573 Test Methods for Chemical Analysis of Fireclay and
excised tissues, especially with regard to handling devices
3
High-Alumina Refractories
whichmaybecomeinvolvedinlitigation,asperPracticeE860.
C623 Test Method for Young’s Modulus, Shear Modulus,
1.4 Asignificant portion of the information associated with
and Poisson’s Ratio for Glass and Glass-Ceramics by
aretrievedimplantdeviceisoftenatthedevice-tissueinterface
Resonance
or in the tissues associated with the implant and related organ
C633 Test Method for Adhesion or Cohesion Strength of
systems.Attention should be given to the handling of adjacent
Thermal Spray Coatings
tissues, so as not to interfere with study of the particles in the
C674 Test Methods for Flexural Properties of Ceramic
adjacent tissue, a chemical analysis for the byproducts of
Whiteware Materials
degradation of the implant, or a study of the cellular response
C730 TestMethodforKnoopIndentationHardnessofGlass
to the implant.
C1069 TestMethodforSpecificSurfaceAreaofAluminaor
Quartz by Nitrogen Adsorption
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
F04.15 on Material Test Methods.
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
Current edition approved Oct. 1, 2005. Published October 2005. Originally
Standards volume information, refer to the standard’s Document Summary page on
approved 1978. Last previous edition approved in 2005 as F561–05. DOI:
the ASTM website.
10.1520/F0561-05A.
3
Withdrawn.
Copyright © ASTM International, 100 Barr Harbor D
...