ASTM F750-87(2007)e1

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.
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Designation: F750 − 87(Reapproved 2007)
Standard Practice for
Evaluating Material Extracts by 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.
´ NOTE—Formatting and grammar were corrected editorially throughout in April 2007.
1. Scope 4. Significance and Use
4.1 This practice is intended to help assess the biocompat-
1.1 This practice covers a nonspecific, acute toxicity test
ibility of materials used in medical devices. It is an acute
used for detecting leachables from materials used in medical
toxicological test designed to detect the presence of injurious
devices.
leachable substances.
1.2 The liquids injected into the mouse are those obtained
4.2 This practice may not be appropriate for all types of
by Practice F619 where the extraction vehicles are saline,
implant applications. The user is cautioned to consider the
vegetable oil, or other liquids simulating human body fluids.
appropriateness of the method in view of the materials being
1.3 Two procedures are outlined: MethodAfor intravenous tested, their potential applications, and the recommendations
contained in Practice F748.
injection and Method B for intraperitoneal injection.
4.3 The only limitation applicable is the extract preparation.
1.4 This practice is one of several developed for the
Refer to Sections 4.3 and 4.4 of Practice F619 for a description
assessment of the biocompatibility of materials. Practice F748
of this limitation.
may provide guidance for the selection of appropriate methods
for testing materials for a specific application.
5. Apparatus
5.1 Mice—The mice shall be albino-type, healthy and not
2. Referenced Documents
previously used, and shall weigh between 17 and 23 g.Animal
2.1 ASTM Standards:
care shall be in accordance with the “Guide for Care and Use
F619 Practice for Extraction of Medical Plastics 3
of Laboratory Animals.” Age, sex, and weight shall be
F748 PracticeforSelectingGenericBiologicalTestMethods
recorded and reported.All the mice for each extraction vehicle
for Materials and Devices
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
3. Summary of Practice
first test group are inconclusive, then 20 more mice will be
needed to complete the test of one extraction vehicle for one
3.1 The extract liquid is prepared in accordance with Prac-
plastic.
tice F619. The extraction vehicles are saline and vegetable oil,
5.1.1 During the test the mice shall be fed normally with
or other extraction vehicles, as described in Practice F619. The
commercially available feed and tap water.
extract liquid is injected into mice, and the animals are
observed at regular intervals for 72 h for reactions, survival, 5.2 Cages—There shall be one cage for the five mice
etc. exposed to one extract liquid. Each mouse in a cage shall be
uniquely identified, and this identification shall be recorded.
Male and female mice shall be housed separately, and their
cages are positioned in a manner which prevents the accidental
ThispracticeisunderthejurisdictionofASTMCommitteeF04onMedicaland
transfer of feces or bedding from cage to cage.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
5.3 Syringe—Sterile syringes, not greater than 3 mL in
Current edition approved Feb. 1, 2007. Published February 2007. Originally
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volume, with a precision of 60.10 mL shall be used.
approved in 1982. Last previous edition approved in 2002 as F750 – 87 (2002) .
DOI: 10.1520/F0750-87R07E01.
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 U.S. Department of Health, Education, andWelfare,GuideforCareandUseof
the ASTM website. Laboratory Animals, Publication No. NIH 78-23, Bethesda, MD, 1978.
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F750 − 87 (2007)
5.3.1 MethodA—Sterile needles of 25 to 27 ⁄2 gage shall be 8.1.2 Agitate each extract liquid vigorously prior to with-
used. drawal of each injection dose to ensure even distribution of the
5.3.2 Method B—Sterile needles of 21 to 26 gage shall be extracted matter. If particulates are clearly present, then the
used. extract liquids shall be injected by the intraperitoneal method.
Optional: measure and record pH.
6. Sampling
8.1.3 For each extraction vehicle, use ten mice, five for the
6.1 Sample in accordance with Practice F619. sample extract liquid and five for the blank extract liquid.
Weigh all mice, and record their weights. Use a system of
7. Sample and Test Specimen
marking to identify each individual mouse within each group
of five.
7.1 General—The sample is the plastic or other material
exposed to the extraction procedure. As a result of the 8.1.4 Inject the predetermined amount (see 7.2.1)ofthe
extraction in Practice F619, for each extraction vehicle there sample extract liquid into the tail vein of each of the five mice.
are available: (1) a sample extract liquid, and (2) a blank Inject the blank extract liquid in the same way into five other
extract liquid. These extract liquids are to be injected into the mice.Theuseofwarmwateroraheatlampmayhelpdilatethe
test animals within 24 h of the end of the extraction procedure. tail veins for ease of injection.
Record the storage conditions if the liquid extract is not used
8.1.5 Observe all animals immediately after injection, again
immediately after preparation.
4 h after injection, and then at 24, 48, and 72 h, respectively,
7.1.1 There are usually two extract liquids (a blank and a
after injection for symptoms of slight, moderate, or marked
sample)preparedfromanextractionvehicle.Samplesbasedon
toxicity or death (Table 1). Record the observations. Measure
other extraction vehicles may be available, as described in
and record the body weights of all animals at 24, 48, and 72 h
Practice F619, or as required by the standard for the medical
postinjection.
device.
8.2 Method B, Intraperitoneal:
7.2 Method A, Intravenous:
8.2.1 Method B is to be used with vegetable oil and similar
7.2.1 The extract liquid is usually prep
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