ASTM F750-20
(Practice)Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
Standard Practice for Evaluating Acute Systemic Toxicity of Material Extracts by Systemic Injection in the Mouse
SIGNIFICANCE AND USE
4.1 This practice is intended to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological test designed to detect the presence of injurious leachable substances.
4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations contained in Practice F748.
4.3 The only limitation applicable is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description of this limitation.
SCOPE
1.1 This practice covers a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.
1.2 The liquids injected into the mouse are those obtained by Practice F619 where the extraction vehicles are saline, vegetable oil, or other liquids simulating human body fluids.
1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide guidance for the selection of appropriate methods for testing materials for a specific application.
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 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.
1.7 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.
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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: F750 − 20
Standard Practice for
Evaluating Acute Systemic Toxicity of Material Extracts by
1
Systemic Injection in the Mouse
ThisstandardisissuedunderthefixeddesignationF750;thenumberimmediatelyfollowingthedesignationindicatestheyearoforiginal
adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.Asuperscript
epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope F748 PracticeforSelectingGenericBiologicalTestMethods
for Materials and Devices
1.1 This practice covers a nonspecific, acute toxicity test
used for detecting leachables from materials used in medical
3. Summary of Practice
devices.
3.1 The extract liquid is prepared in accordance with Prac-
1.2 The liquids injected into the mouse are those obtained
tice F619. The extraction vehicles are saline and vegetable oil,
by Practice F619 where the extraction vehicles are saline,
or other extraction vehicles, as described in Practice F619.The
vegetable oil, or other liquids simulating human body fluids.
extract liquid is injected into mice, and the animals are
1.3 Two procedures are outlined: MethodAfor intravenous
observed at regular intervals for 72 h for reactions, survival,
injection and Method B for intraperitoneal injection.
etc.
1.4 This practice is one of several developed for the
4. Significance and Use
assessment of the biocompatibility of materials. Practice F748
may provide guidance for the selection of appropriate methods 4.1 This practice is intended to help assess the biocompat-
for testing materials for a specific application. ibility of materials used in medical devices. It is an acute
toxicological test designed to detect the presence of injurious
1.5 The values stated in SI units are to be regarded as
leachable substances.
standard. No other units of measurement are included in this
standard. 4.2 This practice may not be appropriate for all types of
implant applications. The user is cautioned to consider the
1.6 This standard does not purport to address all of the
appropriateness of the method in view of the materials being
safety concerns, if any, associated with its use. It is the
tested, their potential applications, and the recommendations
responsibility of the user of this standard to establish appro-
contained in Practice F748.
priate safety, health, and environmental practices and deter-
mine the applicability of regulatory limitations prior to use.
4.3 The only limitation applicable is the extract preparation.
1.7 This international standard was developed in accor-
Refer to Sections 4.3 and 4.4 of Practice F619 for a description
dance with internationally recognized principles on standard-
of this limitation.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- 5. Apparatus
mendations issued by the World Trade Organization Technical
5.1 Mice—The mice shall be albino-type, healthy, and not
Barriers to Trade (TBT) Committee.
previously used, and shall weigh between 17 and 23 g.Animal
care shall be in accordance with the “Guide for the Care and
2. Referenced Documents
3
Use of Laboratory Animals.” Age, sex, and weight shall be
2
2.1 ASTM Standards:
recorded and reported.All the mice for each extraction vehicle
F619 Practice for Extraction of Medical Plastics
shall be from the same source. For each extraction vehicle, a
minimum of ten mice are used in the test. If the results of this
first test group are inconclusive, then 20 more mice will be
1
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
needed to complete the test of one extraction vehicle for one
Surgical Materials and Devices and is the direct responsibility of Subcommittee
plastic.
F04.16 on Biocompatibility Test Methods.
Current edition approved June 1, 2020. Published August 2020. Originally
5.1.1 During the test the mice shall be fed normally with
approved in 1982. Last previous edition approved in 2012 as F750 – 87 (2012).
commercially available feed and tap water.
DOI: 10.1520/F0750-20.
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
3
Standards volume information, refer to the standard’s Document Summary page on NationalResearchCouncil,GuidefortheCareandUseofLaboratoryAnimals,
the ASTM website. National Academy Press, Washington, DC, 2011.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
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F750 − 20
5.2 Cages—There shall be one cage for the five
...
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: F750 − 87 (Reapproved 2012) F750 − 20
Standard Practice for
Evaluating Acute Systemic Toxicity of Material Extracts by
1
Systemic Injection in the Mouse
This standard is issued under the fixed designation F750; 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 a nonspecific, acute toxicity test used for detecting leachables from materials used in medical devices.
1.2 The liquids injected into the mouse are those obtained by Practice F619 where the extraction vehicles are saline, vegetable
oil, or other liquids simulating human body fluids.
1.3 Two procedures are outlined: Method A for intravenous injection and Method B for intraperitoneal injection.
1.4 This practice is one of several developed for the assessment of the biocompatibility of materials. Practice F748 may provide
guidance for the selection of appropriate methods for testing materials for a specific application.
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 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.
1.7 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.
2. Referenced Documents
2
2.1 ASTM Standards:
F619 Practice for Extraction of Medical Plastics
F748 Practice for Selecting Generic Biological Test Methods for Materials and Devices
3. Summary of Practice
3.1 The extract liquid is prepared in accordance with Practice F619. The extraction vehicles are saline and vegetable oil, or other
extraction vehicles, as described in Practice F619. The extract liquid is injected into mice, and the animals are observed at regular
intervals for 72 h for reactions, survival, etc.
4. Significance and Use
4.1 This practice is intended to help assess the biocompatibility of materials used in medical devices. It is an acute toxicological
test designed to detect the presence of injurious leachable substances.
4.2 This practice may not be appropriate for all types of implant applications. The user is cautioned to consider the
appropriateness of the method in view of the materials being tested, their potential applications, and the recommendations
contained in Practice F748.
4.3 The only limitation applicable is the extract preparation. Refer to Sections 4.3 and 4.4 of Practice F619 for a description
of this limitation.
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 F04.16
on Biocompatibility Test Methods.
Current edition approved Oct. 1, 2012June 1, 2020. Published October 2012August 2020. Originally approved in 1982. Last previous edition approved in 20072012 as
ε1
F750 – 87 (2007)(2012). . DOI: 10.1520/F0750-87R12.10.1520/F0750-20.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
1
---------------------- Page: 1 ----------------------
F750 − 20
5. Apparatus
5.1 Mice—The mice shall be albino-type, healthy, and not previously used, and shall weigh between 17 and 23 g. Animal care
3
shall be in accordance with the “Guide for the Care and Use of Laboratory Animals.” Age, sex, and weight shall be recorded and
reported. All the mice for each extraction vehicle shall be from the same source. For each extraction vehicle, a minimum of ten
mice are used in the test. If the results of this first test group are inconclusive, then 20 more mice will be needed to complete the
test of one extraction vehicle for one plastic.
5.1.1 During the tes
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