ASTM F2901-13
(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 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
Relations
Buy Standard
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NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F2901 − 13
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 cal Devices—Part 18: Chemical Characterization of Ma-
3
terials
1.1 Medical devices may cause adverse effects on the
ANSI/AAMI ST72 :2010 Bacterial Endotoxins—Test
structure and/or function of the nervous system. In this guide,
Methodologies, Routine Monitoring, and Alternatives to
these adverse effects are defined as neurotoxicity. This guide
3
Batch Testing
provides background information and recommendations on
4
USP <151> Rabbit Pyrogen Test
methods for neurotoxicity testing. This guide should be used
USP <161> Transfusion and Infusion Assemblies and Simi-
with Practice F748, and may be helpful where neurotoxicity
4
lar Medical Devices
testing is needed to evaluate medical devices that contact
nervous system tissue or cerebral spinal fluid (CSF).
3. Summary of Guide
1.2 This standard does not purport to address all of the
3.1 This is an informative guide and should be used with
safety concerns, if any, associated with its use. It is the
Practice F748.
responsibility of the user of this standard to establish appro-
priate safety and health practices and determine the applica-
3.2 The duration of contact between the tissue and medical
bility of regulatory limitations prior to use.
device should be considered when determining the appropriate
panel of testing. This guide may not address neurosurgical
2. Referenced Documents
instruments or medical devices that have transient incidental
2
2.1 ASTM Standards: contact with the nervous system due to the limited tissue
F748 PracticeforSelectingGenericBiologicalTestMethods contact duration.
for Materials and Devices
3.3 The evaluation of neurotoxicity should be considered in
F1904 Practice for Testing the Biological Responses to
conjunction with material characterization and other informa-
Particles in vivo
tion such as non-clinical tests, clinical studies, post-market
2.2 Other Referenced Documents:
experience, and intended use.
ISO/AAMI/ANSI 10993-3 :2003 Biological Evaluation of
Medical Devices—Part 3: Tests for Genotoxicity,
4. Significance and Use
3
Carcinogenicity, and Reproductive Toxicity
4.1 The objective of this guide is to recommend a panel of
ISO/AAMI/ANSI 10993-5 :2009 Biological Evaluation of
3 biological tests that can be used in addition to the testing
Medical Devices—Part 5: Tests for In Vitro Cytotoxicity
recommended in Practice F748. This guide is designed to
ISO 10993–11 : 2006 Biological Evaluation of Medical
detect neurotoxicity caused by medical devices that contact
Devices—Part 11: Tests for Systemic Toxicity
nervous tissue.
ISO/AAMI/ANSI 10993-18 Biological Evaluation of Medi-
4.2 The testing recommendations should be considered for
new materials, established materials with different manufactur-
1
This guide is under the jurisdiction of ASTM Committee F04 on Medical and ing methods that could affect nervous tissue response, or
Surgical Materials and Devices and is the direct responsibility of Subcommittee
materials used in new nervous tissue applications.
F04.16 on Biocompatibility Test Methods.
Current edition approved Feb. 1, 2013. Published February 2013. Originally
4.3 Chemical characterization can be used to evaluate simi-
approved in 2012. Last previous edition approved in 2012 as F2901 – 12. DOI:
larity for materials with a history of clinical use in a similar
10.1520/F2901–13.
nervous tissue application.
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 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
1
---------------------- Page: 1 ----------------------
F2901 − 13
5. Tests for Neurotoxicity shouldincludetheimplant-tissueinterfaceandincludesection-
ing of sufficient area around the implant to ensure that the
5.1 Testing should be performed on the final sterilized
potential effects of diffusion of degradable and/or leachable
device, representative samples from the final sterilized device,
materials are
...
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 − 12 F2901 − 13
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 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
F1904 Practice for Testing the Biological Responses to Particles in vivo
2.2 Other Referenced Documents:
ISO/AAMI/ANSI 10993-3 :2003Biological :2003 Biological Evaluation of Medical Devices—Part 3: Tests for Genotoxicity,
3
Carcinogenicity, and Reproductive Toxicity
3
ISO/AAMI/ANSI 10993-5 :2009 Biological Evaluation of Medical Devices—Part 5: Tests for In Vitro Cytotoxicity
ISO 10993–11 : 2006 Biological Evaluation of Medical Devices—Part 11: Tests for Systemic Toxicity
3
ISO/AAMI/ANSI 10993-18 Biological Evaluation of Medical Devices—Part 18: Chemical Characterization of Materials
3
ANSI/AAMI ST72 :2010 Bacterial Endotoxins—Test Methodologies, Routine 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.
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 in conjunction with material characterization and other information
such as non-clinical tests, clinical studies, post-market experience, and intended use.
4. 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.
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 Sept. 1, 2012Feb. 1, 2013. Published October 2012February 2013. Originally approved in 2012. Last previous edition approved in 2012 as
F2901 – 12. DOI: 10.1520/F2901–12.10.1520/F2901–13.
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 − 13
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.
5
...
Questions, Comments and Discussion
Ask us and Technical Secretary will try to provide an answer. You can facilitate discussion about the standard in here.