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ASTM F2901-12

(Guide)

Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

SIGNIFICANCE AND USE
The objective of this guide is to recommend a panel of biological tests that can be used in addition to the testing recommended in Practice F748. This guide is designed to detect neurotoxicity caused by medical devices that contact nervous tissue.
The testing recommendations should be considered for new materials, established materials with different manufacturing methods that could affect nervous tissue response, or materials used in new nervous tissue applications.
Chemical characterization can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.
SCOPE
1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748, and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact nervous system tissue or cerebral spinal fluid (CSF).
1.2 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
31-Aug-2012
ICS
11.040.01 - Medical equipment in general
Technical Committee
F04 - Medical and Surgical Materials and Devices
Drafting Committee
F04.16 - Biocompatibility Test Methods
Current Stage
Ref Project

Relations

Replaced By
ASTM F2901-13 - Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
Effective Date
01-Feb-2013
Referred By
ASTM E3219-20 - Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
Effective Date
01-Sep-2012

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ASTM F2901-12 - Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical DevicesASTM F2901-12 - Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
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ASTM F2901-12 - Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices
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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: F2901 − 12
StandardGuide for
Selecting Tests to Evaluate Potential Neurotoxicity of
Medical Devices
This standard is issued under the fixed designation F2901; 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 Methodologies, Routine Monitoring, and Alternatives to
Batch Testing
1.1 Medical devices may cause adverse effects on the
USP <161> Transfusion and Infusion Assemblies and Simi-
structure and/or function of the nervous system. In this guide,
lar Medical Devices
these adverse effects are defined as neurotoxicity. This guide
provides background information and recommendations on
3. Summary of Guide
methods for neurotoxicity testing. This guide should be used
3.1 This is an informative guide and should be used with
with Practice F748, and may be helpful where neurotoxicity
Practice F748.
testing is needed to evaluate medical devices that contact
nervous system tissue or cerebral spinal fluid (CSF).
3.2 The duration of contact between the tissue and medical
device should be considered when determining the appropriate
1.2 This standard does not purport to address all of the
panel of testing. This guide may not address neurosurgical
safety concerns, if any, associated with its use. It is the
instruments or medical devices that have transient incidental
responsibility of the user of this standard to establish appro-
contact with the nervous system due to the limited tissue
priate safety and health practices and determine the applica-
contact duration.
bility of regulatory limitations prior to use.
3.3 The evaluation of neurotoxicity should be considered in
2. Referenced Documents
conjunction with material characterization and other informa-
tion such as non-clinical tests, clinical studies, post-market
2.1 ASTM Standards:
experience, and intended use.
F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
4. Significance and Use
F1904 Practice for Testing the Biological Responses to
Particles in vivo 4.1 The objective of this guide is to recommend a panel of
biological tests that can be used in addition to the testing
2.2 Other Referenced Documents:
recommended in Practice F748. This guide is designed to
ISO/AAMI/ANSI 10993-3 :2003Biological Evaluation of
detect neurotoxicity caused by medical devices that contact
Medical Devices—Part 3: Tests for Genotoxicity,
nervous tissue.
Carcinogenicity, and Reproductive Toxicity
ISO/AAMI/ANSI 10993-5 :2009 Biological Evaluation of
4.2 The testing recommendations should be considered for
Medical Devices—Part 5: Tests for In Vitro Cytotoxicity
new materials, established materials with different manufactur-
ISO/AAMI/ANSI 10993-18 Biological Evaluation of Medi-
ing methods that could affect nervous tissue response, or
cal Devices—Part 18: Chemical Characterization of Ma-
materials used in new nervous tissue applications.
terials
4.3 Chemical characterization can be used to evaluate simi-
ANSI/AAMI ST72 :2010 Bacterial Endotoxins—Test
larity for materials with a history of clinical use in a similar
nervous tissue application.
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
5. Tests for Neurotoxicity
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods. 5.1 Testing should be performed on the final sterilized
Current edition approved Sept. 1, 2012. Published October 2012. DOI: 10.1520/
device, representative samples from the final sterilized device,
F2901–12.
ormaterialsprocessedinthesamemannerasthefinalsterilized
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
device. Testing of individual materials may be useful for
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website.
3 4
Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
4th Floor, New York, NY 10036, http://www.ansi.org. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2901 − 12
research and development, but the definitive neurotoxicity ation should be given to whether cross or transverse sectioning
evaluation should include all materials in the final version of best captures the area of interest depending on the anatomical
the device. The test article should be exposed to all phases of region. The test period should be determined by the clinical
manufacturing including processing, cleaning, sterilization, exposure time, or go beyond the point where a tissue response
and packaging.
steady state has been reached. The time course of the study
5.1.1 A complete description of all device materials and should be designed and justified based on the intended clinical
reagents used during manufacturing and processing should be
use.Finally,afunctionalobservationbatterydesignedtodetect
provided with information on the source, purity, and toxicity signs of neurobehavioral dysfunction is recommended to
profile. Chemical characterization studies can provide addi-
compliment the histopathological assessments.
tionalinformationonthedevicesafetyprofile.SeeISO/AAMI/
5.2.4 Pyrogen Testing—Pyrogen testing on the final steril-
ANSI 10993-18 for information on chemical characterization
ized medical device is recommended to reduce the likelihood
of materials.
of a neuroinflammatory response to the device. Material-
mediated pyrogen testing should be conducted using the rabbit
5.2 The following tests should be considered to assess
pyrogen test. Endotoxin testing with an assay such as the
neurotoxicityofmedicaldeviceswithinthescopeofthisguide.
Limulus Amebocyte Lysate (LAL) assay should be conducted
5.2.1 Cytotoxicity—Cytotoxicity assays are sensitive
screening tools that generally serve as a starting point for in compliance with ANSI/AAMI ST72 and USP <161>.
evaluating medical device biocompatibility. See X1.4 for
5.2.5 Wear Particle Testing—The proximity of orthopedic
information on neuro-cytotoxicity testing.
spine devices to the spinal cord and nerve roots may warrant
5.2.2 Genotoxicity—Nervous tissue contains proliferating
evaluation of potential neurotoxicity. Devices capable of gen-
cell populations, and can respond to device implantation with
erating wear particles should be evaluated if the wear particles
a proliferative response. Nervous tissue is also known to give
have not already been adequately tested for potential neuro-
rise to various tumor types. To ensure medical devices do not
toxicity. If particle testing is warranted, an appropriately
include genotoxic chemicals, the use of a panel of genotoxicity
justifiedanimalstudyisrecommended.SeePracticeF1904and
tests is recommended. The panel of genotoxicity tests should
reference by Cunningham (4) for examples of particle-
include a bacterial assay and mammalian assays capable of
mediated neurotoxicity evaluation methods. The animal study
detecting both gene level and clastogenic mutations. See
shou
...

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SCOPE
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SIGNIFICANCE AND USE
5.1 This guide provides information on how to select the test soil(s) that best simulates clinical use for devices. The test soil(s) selected for the validation should be clinically relevant and simulate what the device/component will come into contact with during the clinical procedure.  
5.2 This guide will help standardize the test soils used by medical device manufacturers when validating the cleaning procedures of reusable medical devices and reprocessing equipment  
5.3 For devices that come into contact with blood, the simulated test soils are blood-based soils, such as those described under 7.1.1-7.1.2.  
5.4 For devices that come into contact with mucus, the simulated test soils are those described under 7.1.3.  
5.5 For devices that come in contact with soils of a source other than the patient (e.g., bone cement), the simulated test soils should be similar to those described in 7.2. These can be used alone or in combination with 7.1.  
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5.7 Any simulated test soil(s) or formulations can be used for simulated use testing but shall be scientifically justified by the medical device manufacturer.
SCOPE
1.1 This guide describes methods for selecting test soils for cleaning validations based upon the characteristics of the soil, the physical characteristics of the device, and the clinical use of the device.  
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1.4 The test soils are designed to simulate the contaminants that medical devices are likely to come in contact with during clinical use. The test soils discussed in this guide are a mixture of constituents that simulate what is commonly found in human secretions, blood, tissue, and bone fragments/shavings as well as non-patient derived soil (e.g., bone cement, lubricants, and dyes) during clinical procedures. The test soils also simulate the physical parameters (e.g., viscosity, adhesion) of clinical material to which the medical devices will be exposed.  
1.5 Exclusion:  
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1.5.2 This guide does not describe the soil/inoculum used for validation of disinfection or sterilization instructions. Disinfection or sterilization validation requires separate testing that is independent of cleaning validation studies.  
1.5.3 Test soils described are not intended for use by health care facilities to verify the effectiveness of their cleaning process.  
1.5.4 The test soil recipes are not intended to encompass every biological residue with which a medical device is likely to come into contact.  
1.6...

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5.1 Materials used in medical devices are selected in part for their biocompatibility, meaning that they have been demonstrated to have an acceptable biological response for the intended application. During manufacturing, most devices are exposed to a variety of processing steps and materials that have the potential to adversely affect the inherent biocompatibility of the device if they are not adequately removed prior to use.  
Note 1: For a fine powder, depending upon application, a new biological risk assessment may be required.  
5.2 In additive manufacturing, components are in most cases built layer-by-layer, allowing unprecedented freedom to design complex devices. This makes it possible to build devices that are very difficult to clean, such as topological optimized parts, small internal channels, lattice structures, and especially reticulated porous structures for bone ingrowth and fixation.  
5.3 Powdered fusion AM presents additional challenges. Components come out of the build volume with residual powder filling all open spaces within the device. The majority of the excess powder is typically removed by a combination of vibratory shaking, blowing with compressed gas, vacuuming, and ultrasonic cleaning in a solvent. However, the particles are typically very small and can become lodged in internal features such as pores, making removal difficult. Furthermore, particles that were immediately adjacent to the component during manufacturing can be partially sintered to the surface. Those particles can be extremely difficult to remove, are indistinguishable from loose particles when observed by most techniques, and may be at risk of detaching during the intended use of the device.  
5.4 This guide provides specific evaluation techniques for measuring the effectiveness of residue removal processes, as they should be able to yield consistent results that meet the respective performance and cleanliness criteria for the intended use.
SCOPE
1.1 This standard provides guidance for assessing the manufacturing material residues in medical devices fabricated using additive manufacturing (AM) techniques, specifically, from powder bed fusion AM technologies.  
1.1.1 Some of the techniques discussed in this guide may be applicable to devices fabricated by other types of AM equipment (e.g., stereolithography). Given each AM technique’s characteristics and post-processing challenges, there could be additional risks or considerations associated with some AM techniques or materials that are not addressed by this guide.  
1.2 This guide covers several qualitative and quantitative assessments of the presence and amount of residue remaining in or obtained by extraction in aqueous or organic solvents from powder bed fusion AM medical components.  
1.2.1 This guide identifies techniques to qualitatively determine the presence of residue and a technique to quantitatively assess it. It does not set acceptance criteria or acceptable limits for residues remaining in built parts. These methods are not the only methods to determine the presence or quantity of residual material in additive manufactured medical components.  
1.3 This guide pertains to devices in their finished state (after post-processing and subsequent manufacturing processes), as applicable. This guide may also be used to evaluate the effectiveness of cleaning processes between critical steps in the manufacturing process, to ensure minimal AM residue remains for cleaning processes downstream.  
1.4 This guide is not intended to evaluate the residue level in medical components that have been cleaned for reuse.  
1.5 Different cleaning methods, including high energy processes, can potentially damage small structures in AM parts. This guide does not address measurement or mitigation of this risk.  
1.6 This guide does not address the manufacturing occupational health issues of working with small particles (e.g., breathing hazards).  
1....

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ASTM
ASTM F3357-19(Guide)
Standard Guide for Designing Reusable Medical Devices for Cleanability

SIGNIFICANCE AND USE
4.1 Reusable medical devices have a range of cleanability. The equipment, effort, and time expended for cleaning devices should be feasible in the intended setting. For that reason, it is essential that cleanability be considered during the design phase.  
4.2 The next section highlights features that either have a tendency to retain debris and/or make removing contamination difficult. Individually, the criteria listed in this document may not render a device difficult to clean. Furthermore, it is the manufacturer’s responsibility to consider feasibility and ease of cleaning the device in the clinical environment when designing their device. Although it may not be feasible to remove or modify all of the problematic design features from a device, device manufacturers should be aware of challenging designs for cleaning and take appropriate action for minimizing the impact of these features on cleaning. For example, disassembly may be necessary to thoroughly clean a device, or it may be determined that a device cannot be adequately cleaned, in which case that device would be designated single-use only. In addition, manufacturers should consider the compatibility of their device design with subsequent sterilization or disinfection.
SCOPE
1.1 This guide is intended to provide manufacturers of reusable medical devices design feature guidance to minimize debris retention after use and increase ease of removal of contaminants and cleaning product residuals from devices during cleaning/rinsing and also prepare for subsequent processing steps (for example, sterilization or disinfection).  
1.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 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.

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ASTM
ASTM F2901-19(Guide)
Standard Guide for Selecting Tests to Evaluate Potential Neurotoxicity of Medical Devices

SIGNIFICANCE AND USE
4.1 The objective of this guide is to recommend a panel of biological tests that can be used in addition to the testing recommended in Practice F748. This guide is designed to detect neurotoxicity caused by medical devices that contact nervous tissue.  
4.2 The testing recommendations should be considered for new materials, established materials with different manufacturing methods that could affect nervous tissue response, or materials used in new nervous tissue applications.  
4.3 Chemical characterization can be used to evaluate similarity for materials with a history of clinical use in a similar nervous tissue application.
SCOPE
1.1 Medical devices may cause adverse effects on the structure and/or function of the nervous system. In this guide, these adverse effects are defined as neurotoxicity. This guide provides background information and recommendations on methods for neurotoxicity testing. This guide should be used with Practice F748, and may be helpful where neurotoxicity testing is needed to evaluate medical devices that contact central and/or peripheral nervous system tissue or cerebral spinal fluid (CSF).
Note 1: The results of these in vitro and in vivo tests may not correspond to actual human response.  
1.2 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.3 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.

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