ASTM F561-19
(Practice)Standard Practice for Retrieval and Analysis of Medical Devices, and Associated Tissues and Fluids
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 healing response. 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 minimizing as best as possible alteration of their form and structure. It is also essential that the tissues be handled in such a way as to avoid microbial or viral contamination of the work place or the investigator. The tissue-device interface may need to be stabilized with chemical fixation prior to separation of the device from it’s in-situ position. It is also highly recommended to document detailed information about the tissue specimens, including location of extraction. 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 analy...
SCOPE
1.1 This practice covers recommendations for the retrieval, handling, and analysis of implanted medical devices and associated specimens that are removed from human and animal subjects during revision surgery and at postmortem. This practice may be used for the analysis of any implant including inert, bioactive, resorbable, and tissue engineered products. This practice can also be used for analysis of specimens and fluids from in vitro tests, including those from wear tests and joint simulators. The aim is to provide guidance to minimize iatrogenic damage during the recovery and handling of the associated specimens which could obscure the investigational results. This practice is also intended to provide guidance as to gathering data at the proper time and circumstance.
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. Note that regulations for handling of patient information, tissues, and retrieved devices will vary by geography.
1.3 This practice should be applied in accordance with pertinent regulations or legal requirements regarding the handling of patient data as well as the handling and analysis of retrieved implants and excised tissues, especially with regard to handling devices which may become involved in litigation, as in accordance with Practice E...
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This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: F561 − 19
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 1.4 Asignificant portion of the information associated with
aretrievedimplantdeviceisoftenatthedevice-tissueinterface
1.1 This practice covers recommendations for the retrieval,
or in the tissues associated with the implant and related organ
handling, and analysis of implanted medical devices and
systems.Attention should be given to the handling of adjacent
associatedspecimensthatareremovedfromhumanandanimal
tissues, so as not to interfere with study of the particles in the
subjects during revision surgery and at postmortem. This
adjacent tissue, a chemical analysis for the byproducts of
practice may be used for the analysis of any implant including
degradation of the implant, or a study of the cellular response
inert, bioactive, resorbable, and tissue engineered products.
to the implant.
This practice can also be used for analysis of specimens and
fluids from in vitro tests, including those from wear tests and 1.5 The values stated in SI units are to be regarded as
joint simulators. The aim is to provide guidance to minimize standard. No other units of measurement are included in this
iatrogenic damage during the recovery and handling of the standard.
associated specimens which could obscure the investigational
1.6 This standard may involve hazardous materials,
results.This practice is also intended to provide guidance as to
operations, and equipment. As a precautionary measure, ex-
gathering data at the proper time and circumstance.
planteddevicesshouldbesterilizedorminimallydisinfectedby
an appropriate means that does not adversely affect the
1.2 This practice offers guidelines for the analysis of re-
implant or the associated tissue that may be subject to
trieved implants to limit damage to them, and to allow
comparisons between investigational results from different subsequent analysis. A detailed discussion of precautions to be
used in handling of human tissues can be found in ISO
studies. The protocols are divided into three stages, where
Stage I is the minimum non-destructive analysis, Stage II is 12891-1. This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the
more complete non-destructive analysis, and Stage III is
responsibility of the user of this standard to establish appro-
destructive analysis. Standard protocols for the examination
priate safety, health, and environmental practices and deter-
and collection of data are provided for specific types of
mine the applicability of regulatory limitations prior to use.
materialsinrelationtotheirtypicalapplications.Forparticular
1.7 This international standard was developed in accor-
investigational programs, additional, more specific, protocols
dance with internationally recognized principles on standard-
mayberequired.Ifspecialanalyticaltechniquesareemployed,
ization established in the Decision on Principles for the
the appropriate handling procedures must be specified. Note
Development of International Standards, Guides and Recom-
that regulations for handling of patient information, tissues,
mendations issued by the World Trade Organization Technical
and retrieved devices will vary by geography.
Barriers to Trade (TBT) Committee.
1.3 This practice should be applied in accordance with
pertinent regulations or legal requirements regarding the han-
2. Referenced Documents
dling of patient data as well as the handling and analysis of
2
2.1 ASTM Standards:
retrieved implants and excised tissues, especially with regard
A262Practices for Detecting Susceptibility to Intergranular
to handling devices which may become involved in litigation,
Attack in Austenitic Stainless Steels
as in accordance with Practice E860. Note that regulations for
A751Test Methods, Practices, and Terminology for Chemi-
handling of patient information, tissues, and retrieved devices
cal Analysis of Steel Products
will vary by geography
C20Test Methods forApparent Porosity, WaterAbsorption,
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
Surgical Materials and Devices and is the direct responsibility of Subcommittee
2
F04.15 on Material Test Methods. For referenced ASTM standards, visit the ASTM website, www.astm.org, or
Current edition approved Jan. 1, 20
...
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 − 13 F561 − 19
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 human and animal subjects during revision surgery, at postmortem, or as part of animal
studies. surgery and at postmortem. This practice may be used for the analysis of any implant including inert, bioactive, resorbable,
and tissue engineered products. This practice can also be used for analysis of specimens and lubrication fluids from in vitro tests,
including those from wear tests and joint simulators. The aim is to provide guidance in preventing damage to the to minimize
iatrogenic damage during the recovery and handling of the associated specimens which could obscure the investigational results,
and in results. This practice is also intended to provide guidance as to gathering data at the proper time and circumstance to validate
the study.circumstance.
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. Note that regulations for handling of patient
information, tissues, and retrieved devices will vary by geography.
1.3 This practice recommendation should be applied in accordance with nationalpertinent regulations or legal requirements
regarding the handling of patient data as well as the handling and analysis of retrieved implants and excised tissues, especially with
regard to handling devices which may become involved in litigation, as per in accordance with Practice E860. Note that regulations
for handling of patient information, tissues, and retrieved devices will vary by geography
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 safety, health, and healthenvironmental practices
and determine the applicability of regulatory limitations prior to use.
1.7 This international standard was developed in accordance with internationally recognized principles on standardization
established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued
by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
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 T
...
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