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ASTM F2901-19

(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
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.

General Information

Status
Published
Publication Date
28-Feb-2019
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

Refers
ASTM F748-16 - Standard Practice for Selecting Generic Biological Test Methods for Materials and Devices
Effective Date
01-Apr-2016
Refers
ASTM F756-17 - Standard Practice for Assessment of Hemolytic Properties of Materials
Effective Date
01-Mar-2017
Referred By
ASTM E3219-20 - Standard Guide for Derivation of Health-Based Exposure Limits (HBELs)
Effective Date
01-Mar-2019

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

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: F2901 − 19
Standard Guide for
Selecting Tests to Evaluate Potential Neurotoxicity of
1
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 2.2 Other Referenced Documents:
ISO 10993-1 Biological Evaluation of Medical Devices—
1.1 Medical devices may cause adverse effects on the
Part 1: Evaluation andTestingWithin a Risk Management
structure and/or function of the nervous system. In this guide,
Process
these adverse effects are defined as neurotoxicity. This guide
ISO 10993-3 Biological Evaluation of Medical Devices—
provides background information and recommendations on
Part 3: Tests for Genotoxicity, Carcinogenicity, and Re-
methods for neurotoxicity testing. This guide should be used
3
productive Toxicity
with Practice F748, and may be helpful where neurotoxicity
ISO 10993-5 Biological Evaluation of Medical Devices—
testing is needed to evaluate medical devices that contact
3
Part 5: Tests for In Vitro Cytotoxicity
central and/or peripheral nervous system tissue or cerebral
ISO 10993-6 Biological Evaluation of Medical Devices—
spinal fluid (CSF).
Part 6: Tests for Local Effects After Implantation
NOTE 1—The results of these in vitro and in vivo tests may not
correspond to actual human response.
ISO 10993–11 Biological Evaluation of Medical Devices—
Part 11: Tests for Systemic Toxicity
1.2 This standard does not purport to address all of the
safety concerns, if any, associated with its use. It is the ISO 10993-18 Biological Evaluation of Medical Devices—
3
responsibility of the user of this standard to establish appro- Part 18: Chemical Characterization of Materials
priate safety, health, and environmental practices and deter- ANSI/AAMI ST72 Bacterial Endotoxins—Test
mine the applicability of regulatory limitations prior to use. Methodologies, Routine Monitoring, and Alternatives to
3
1.3 This international standard was developed in accor-
Batch Testing
4
dance with internationally recognized principles on standard- USP <151> Rabbit Pyrogen Test
ization established in the Decision on Principles for the
USP <161> Transfusion and Infusion Assemblies and Simi-
4
Development of International Standards, Guides and Recom-
lar Medical Devices
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee.
3. Summary of Guide
3.1 This is an informative guide and should be used with
2. Referenced Documents
Practice F748.
2
2.1 ASTM Standards:
3.2 The duration of contact between the tissue and medical
F748 PracticeforSelectingGenericBiologicalTestMethods
device should be considered when determining the appropriate
for Materials and Devices
F756 Practice for Assessment of Hemolytic Properties of panel of testing. This guide may not address neurosurgical
instruments or medical devices that have transient incidental
Materials
F1904 Practice for Testing the Biological Responses to contact with the nervous system due to the limited tissue
Particles in vivo contact duration.
3.3 The evaluation of neurotoxicity should be considered in
conjunction with material characterization and other informa-
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and
tion such as non-clinical tests, clinical studies, post-market
Surgical Materials and Devices and is the direct responsibility of Subcommittee
experience, and intended use.
F04.16 on Biocompatibility Test Methods.
Current edition approved March 1, 2019. Published March 2019. Originally
approved in 2012. Last previous edition approved in 2013 as F2901 – 13. DOI:
10.1520/F2901–19.
2 3
For referenced ASTM standards, visit the ASTM website, www.astm.org, or Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St.,
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Standards volume information, refer to the standard’s Document Summary page on Available from U.S. Pharmacopeia (USP), 12601Twinbrook Pkwy., Rockville,
the ASTM website. MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2901 − 19
4. Significance and Use in-vitro test with cytogenetic evaluation of chromosomal
damage with mammalian cells or an in-vitro mouse lymphoma
4
...

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: F2901 − 13 F2901 − 19
Standard Guide for
Selecting Tests to Evaluate Potential Neurotoxicity of
1
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
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 safety, health, and healthenvironmental 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F756 Practice for Assessment of Hemolytic Properties of Materials
F1904 Practice for Testing the Biological Responses to Particles in vivo
2.2 Other Referenced Documents:
ISO 10993-1 Biological Evaluation of Medical Devices—Part 1: Evaluation and Testing Within a Risk Management Process
ISO/AAMI/ANSIISO 10993-3 :2003 Biological Evaluation of Medical Devices—Part 3: Tests for Genotoxicity,
3
Carcinogenicity, and Reproductive Toxicity
3
ISO/AAMI/ANSIISO 10993-5 :2009 Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity
ISO 10993-6 Biological Evaluation of Medical Devices—Part 6: Tests for Local Effects After Implantation
ISO 10993–11 : 2006 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity
3
ISO/AAMI/ANSIISO 10993-18 Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Materials
ANSI/AAMI ST72ANSI/AAMI ST72 :2010 Bacterial Endotoxins—Test Bacterial Endotoxins—Test Methodologies, Routine
3
Monitoring, and Alternatives to Batch Testing
4
USP <151> Rabbit Pyrogen Test
4
USP <161> Transfusion and Infusion Assemblies and Similar Medical Devices
3. Summary of Guide
3.1 This is an informative guide and should be used with Practice F748.
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.16
on Biocompatibility Test Methods.
Current edition approved Feb. 1, 2013March 1, 2019. Published February 2013March 2019. Originally approved in 2012. Last previous edition approved in 20122013
as F2901 – 12.F2901 – 13. DOI: 10.1520/F2901–13. 10.1520/F2901–19.
2
For referenced ASTM standards, visit the ASTM website, www.astm.org, or 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
Available from American National Standards Institute (ANSI), 25 W. 43rd St., 4th Floor, New York, NY 10036, http://www.ansi.org.
4
Available from U.S. Pharmacopeia (USP), 12601 Twinbrook Pkwy., Rockville, MD 20852-1790, http://www.usp.org.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1

---------------------- Page: 1 ----------------------
F2901 − 19
3.2 The duration of contact between the tissue and medical device should be considered when determining the appropriate panel
of testing. This guide may not address neurosurgical instruments or medical devices that have transient incidental contact with the
nervous system due to the limited tissue contact duration.
3.3 The evaluation of neurotoxicity should be considered
...

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SCOPE
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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.  
5.6 A combination of test soils may be used (e.g., blood with mucus) to simulate clinical soiling. For example, flexible endoscopes may come in contact with a different combination of sources of soiling (e.g., gastrointestinal (GI) tract, vasculature for biopsies) during clinical use.  
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.  
1.2 This guide describes the preparation and use of some test soils for the validation of cleaning instructions for reusable medical devices.  
1.3 Reusable medical devices such as endoscopes, arthroscopic shavers, surgical instruments, and suction tubes are exposed to biological soils during clinical use. Preparation of these devices for reuse requires cleaning and disinfection and/or sterilization as applicable. Adequate cleaning is the first step in a process intended to prevent contaminant transfer to the next patient and medical practitioner. The soils, if inadequately removed, can interfere with disinfection and sterilization processes, as well as performance of the device. Acceptance criteria are based either on a visual assessment or quantitatively specified marker(s) endpoint(s) of the soil or both (ISO/TS 15883-5, Section 1). Endpoints after cleaning should be based upon possible interference with disinfection/sterilization, risk to the patient or health care worker from the contaminant during further handling, and endpoints for cleaning established in the scientific literature.  
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:  
1.5.1 This guide does not include methods to validate cleaning processes to remove residues from manufacturing  
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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ASTM
ASTM F3335-20(Guide)
Standard Guide for Assessing the Removal of Additive Manufacturing Residues in Medical Devices Fabricated by Powder Bed Fusion

SIGNIFICANCE AND USE
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 F3293-18(Guide)
Standard Guide for Application of Test Soils for the Validation of Cleaning Methods for Reusable Medical Devices

SIGNIFICANCE AND USE
5.1 This standard guide may be used by medical device manufacturers as part of their design plan and implementation of the validation of the cleaning instructions of their reusable medical devices.  
5.2 It may help medical device manufacturers identify the most inaccessible locations on their device for inoculation with clinically relevant, simulated-use test soil (see ASTM F3208), thereby allowing testing to evaluate whether or not the medical device can be adequately cleaned.  
5.3 Methods described include pipetting, brushing, immersing, spraying, handling, and other techniques for applying soil.  
5.4 Guidance is given as to how to identify the clinically relevant areas of the device to soil, the time allowed for the soil to dry, and other conditioning considerations based upon assessment of worst-case clinical conditions.
SCOPE
1.1 This guide provides methods and considerations for simulated soiling of reusable medical devices for the purpose of validating cleaning instructions. Techniques for application of soil, as well as incorporation of soil by various means (e.g., actuation of devices) will be described in order to assure worst-case contamination of the surface geometry of medical devices.  
1.2 Units—The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.  
1.3 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.  
1.4 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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