ASTM F561-13

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

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 in vitro simulation.  
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...
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 ana...

General Information

• Status: Historical
• Publication Date: 31-Aug-2013
• 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 F561-05a(2010) - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 01-Sep-2013
• Replaced By: ASTM F561-19 - Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
• Effective Date: 01-Jan-2019
• Referred By: ASTM F1877-16 - Standard Practice for Characterization of Particles
• Effective Date: 01-Sep-2013
• Referred By: ASTM F3108-19 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Knee Reconstructive Surgery
• Effective Date: 01-Sep-2013
• Referred By: ASTM F2423-11(2020) - Standard Guide for Functional, Kinematic, and Wear Assessment of Total Disc Prostheses
• Effective Date: 01-Sep-2013
• Referred By: ASTM F2624-12(2020) - Standard Test Method for Static, Dynamic, and Wear Assessment of Extra-Discal Single Level Spinal Constructs
• Effective Date: 01-Sep-2013
• 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-Sep-2013
• 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-Sep-2013
• 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-Sep-2013
• 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-Sep-2013
• Referred By: ASTM F2789-10(2020) - Standard Guide for Mechanical and Functional Characterization of Nucleus Devices
• Effective Date: 01-Sep-2013
• Referred By: ASTM F2694-16(2020) - Standard Practice for Functional and Wear Evaluation of Motion-Preserving Lumbar Total Facet Prostheses
• Effective Date: 01-Sep-2013
• 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-Sep-2013
• Referred By: ASTM F3448-20 - Standard Guide for Clinical Outcomes for Clinical Trials and/or Clinical Registries for Hip Reconstructive Surgery
• Effective Date: 01-Sep-2013
• Referred By: ASTM F3047M-23 - Standard Guide for High Demand Hip Simulator Wear Testing of Hard-on-Hard Articulations
• Effective Date: 01-Sep-2013

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 − 13
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 adjacent tissue, a chemical analysis for the byproducts of
degradation of the implant, or a study of the cellular response
1.1 This practice covers recommendations for the retrieval,
to the implant.
handling, and analysis of implanted medical devices and
1.5 The values stated in SI units are to be regarded as
associated specimens that are removed from patients during
standard. No other units of measurement are included in this
revision surgery, at postmortem, or as part of animal studies.
standard.
This practice can also be used for analysis of specimens and
lubrication fluids from in vitro wear tests and joint simulators. 1.6 This standard may involve hazardous materials,
operations, and equipment. As a precautionary measure, ex-
The aim is to provide guidance in preventing damage to the
associated specimens which could obscure the investigational planteddevicesshouldbesterilizedorminimallydisinfectedby
an appropriate means that does not adversely affect the
results, and in gathering data at the proper time and circum-
implant or the associated tissue that may be subject to
stance to validate the study.
subsequent analysis. A detailed discussion of precautions to be
1.2 This practice offers guidelines for the analysis of re-
used in handling of human tissues can be found in ISO
trieved implants to limit damage to them, and to allow
12891-1. This standard does not purport to address all of the
comparisons between investigational results from different
safety concerns, if any, associated with its use. It is the
studies. The protocols are divided into three stages, where
responsibility of the user of this standard to establish appro-
Stage I is the minimum non-destructive analysis, Stage II is
priate safety and health practices and determine the applica-
more complete non-destructive analysis, and Stage III is
bility of regulatory limitations prior to use.
destructive analysis. Standard protocols for the examination
and collection of data are provided for specific types of
2. Referenced Documents
materialsinrelationtotheirtypicalapplications.Forparticular
2
2.1 ASTM Standards:
investigational programs, additional, more specific, protocols
A262Practices for Detecting Susceptibility to Intergranular
mayberequired.Ifspecialanalyticaltechniquesareemployed,
Attack in Austenitic Stainless Steels
the appropriate handling procedures must be specified.
A751Test Methods, Practices, and Terminology for Chemi-
1.3 This practice recommendation should be applied in cal Analysis of Steel Products
C20Test Methods forApparent Porosity, WaterAbsorption,
accordance with national regulations or legal requirements
Apparent Specific Gravity, and Bulk Density of Burned
regarding the handling and analysis of retrieved implants and
Refractory Brick and Shapes by Boiling Water
excised tissues, especially with regard to handling devices
C158Test Methods for Strength of Glass by Flexure (De-
whichmaybecomeinvolvedinlitigation,asperPracticeE860.
termination of Modulus of Rupture)
1.4 Asignificant portion of the information associated with
C169Test Methods for Chemical Analysis of Soda-Lime
aretrievedimplantdeviceisoftenatthedevice-tissueinterface
and Borosilicate Glass
or in the tissues associated with the implant and related organ
C573Methods for ChemicalAnalysis of Fireclay and High-
3
systems.Attention should be given to the handling of adjacent
Alumina Refractories (Withdrawn 1995)
tissues, so as not to interfere with study of the particles in the
C623Test Method for Young’s Modulus, Shear Modulus,
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
F04.15 on Material Test Methods. Standards volume information, refer to the standard’s Document Summary page on
Current edition approved Sept. 1, 2013. Published October 2013. Originally the ASTM website.
3
approved 1978. Last previous edition approved in 2010 as F561–05a (2010). DOI: The last approved version of this historical standard is referenced on
10.1520/F0561-13 www.astm.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

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This document is not an ASTM standard and is intended only to provide the user of an ASTM standard an indication of what changes have been made to the previous version. Because
it may not be technically possible to adequately depict all changes accurately, ASTM recommends that users consult prior editions as appropriate. In all cases only the current version
of the standard as published by ASTM is to be considered the official document.
Designation: F561 − 05a (Reapproved 2010) F561 − 13
Standard Practice for
Retrieval and Analysis of Medical Devices, and Associated
1
Tissues and Fluids
This standard is issued under the fixed designation F561; 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 (´) indicates an editorial change since the last revision or reapproval.
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
2
2.1 ASTM Standards:
A262 Practices for Detecting Susceptibility to Intergranular Attack in Austenitic Stainless Steels
A751 Test Methods, Practices, and Terminology for Chemical Analysis of Steel Products
C20 Test Methods for Apparent Porosity, Water Absorption, Apparent Specific Gravity, and Bulk Density of Burned Refractory
Brick and Shapes by Boiling Water
C158 Test Methods for Strength of Glass by Flexure (Determination of Modulus of Rupture)
C169 Test Methods for Chemical Analysis of Soda-Lime and Borosilicate Glass
1
This practice is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.15
on Material Test Methods.
Current edition approved Sept. 1, 2010Sept. 1, 2013. Published November 2010October 2013. Originally approved 1978. Last previous edition approved in 20052010 as
F561 – 05a.F561 – 05a (2010). DOI: 10.1520/F0561-05AR10.10.1520/F0561-13
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM Standards
volume information, refer to
...