ASTM F750-87(2002)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: F 750 – 87 (Reapproved 2002)
Standard Practice for
Evaluating Material Extracts by Systemic Injection in the
Mouse
This standard is issued under the fixed designation F 750; 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 (e) indicates an editorial change since the last revision or reapproval.
1. Scope contained in Practice F 748.
4.3 The only limitation applicable is the extract preparation.
1.1 This practice covers a nonspecific, acute toxicity test
Refer to Sections 4.3 and 4.4 of Practice F 619 for a description
used for detecting leachables from materials used in medical
of this limitation.
devices.
1.2 The liquids injected in the mouse are those obtained by
5. Apparatus
Practice F 619 where the extraction vehicles are saline, veg-
5.1 Mice—The mice shall be albino-type, healthy and not
etable oil, or other liquids simulating human body fluids.
previously used, and shall weigh between 17 and 23 g. Animal
1.3 Two procedures are outlined: Method A for intravenous
care shall be in accordance with the “Guide for Care and Use
injection and Method B for intraperitoneal injection.
of Laboratory Animals.” Age, sex, and weight shall be
1.4 This practice is one of several developed for the
recorded and reported. All the mice for each extraction vehicle
assessment of the biocompatibility of materials. Practice F 748
shall be from the same source. For each extraction vehicle, a
may provide guidance for the selection of appropriate methods
minimum of ten mice are used in the test. If the results of this
for testing materials for a specific application.
first test group are inconclusive, then 20 more mice are needed
2. Referenced Documents to complete the test of one extraction vehicle for one plastic.
5.1.1 During the test the mice shall be fed normally with
2.1 ASTM Standards:
commercially available feed and tap water.
F 619 Practice for Extraction of Medical Plastics
5.2 Cages—There shall be one cage for the five mice
F 748 Practice for Selecting Generic Biological Test Meth-
exposed to one extract liquid. Each mouse in a cage shall be
ods for Materials and Devices
uniquely identified, and this identification shall be recorded.
3. Summary of Practice
Male and female mice are housed separately, and their cages
are positioned in a manner which prevents the accidental
3.1 The extract liquid is prepared in accordance with Prac-
transfer of feces or bedding from cage to cage.
tice F 619. The extraction vehicles are saline and vegetable oil,
5.3 Syringe—Sterile syringes, not greater than 3 mL in
or other extraction vehicles, as described in Practice F 619. The
volume, with a precision of 60.10 mL shall be used.
extract liquid is injected into mice, and the animals are
5.3.1 Method A—Sterile needles of 25 to 27 ⁄2 gage shall be
observed at regular intervals for 72 h for reactions, survival,
used.
etc.
5.3.2 Method B—Sterile needles of 21 to 26 gage shall be
4. Significance and Use
used.
4.1 This practice is intended to help assess the biocompat-
6. Sampling
ibility of materials used in medical devices. It is an acute
6.1 Sample in accordance with Practice F 619.
toxicological test designed to detect the presence of injurious
leachable substances.
7. Sample and Test Specimen
4.2 This practice may not be appropriate for all types of
7.1 General—The sample is the plastic or other material
implant applications. The user is cautioned to consider the
exposed to the extraction procedure. As a result of the
appropriateness of the method in view of the materials being
extraction in Practice F 619, for each extraction vehicle there
tested, their potential applications, and the recommendations
are available: (1) a sample extract liquid, and (2) a blank
extract liquid. These extract liquids are to be injected into the
This practice is under the jurisdiction of ASTM Committee F04 on Medical and
test animals within 24 h of the end of the extraction procedure.
Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods.
Current edition approved Sept. 25, 1987. Published November 1987. Originally
published as F 750 – 82. Last previous edition F 750 – 82. U.S. Department of Health, Education, and Welfare, Guide for Care and Use of
Annual Book of ASTM Standards, Vol 13.01. Laboratory Animals, Publication No. NIH 78-23, Bethesda, MD, 1978.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F 750
Record storage conditions if not used immediately after prepa- respectively, after injection for symptoms of slight, moderate,
ration. or marked toxicity or death (Table 1). Record the observations.
7.1.1 There are usually two extract liquids prepared from an Measure and record the body weights of all animals at 24, 48,
extraction vehicle available for test. Samples based on other and 72 h postinjection.
extraction vehicles may be available, as described in Practice 8.2 Method B, Intraperitoneal:
F 619, or as required by the standard for the medical device. 8.2.1 Method B is to be used with vegetable oil and similar
7.2 Method A, Intravenous: extraction vehicles designated for intraperitoneal injection.
7.2.1 The extract liquid is prepared from a saline extraction 8.2.2 Agitate each extract liquid vigorously prior to with-
vehicle. The dose of the extract liquid is 50 mL/kg of body drawal of each injection dose, to ensure even distribution of
weight for each mouse, injected at a steady rate of not more extracted matter. If the extract liquid contains particulates,
than 0.1 mL/s. If a hypotonic or hypertonic extract liquid is record and report observations.
used, then the injection rate is adjusted proportionally. 8.2.3 For each extraction vehicle use ten mice, five for the
7.2.2 Aqueous extract liquids shall be nominally isosmotic sample extract liquid and five for the blank extract liquid.
before injection. For example, sodium chloride may be added Weigh all mice, and record their weight. Use a system of
to distilled water extracts. marking to identify each individual mouse within each group
7.3 Method B, Intraperitoneal—The extract liquid is pre- of five.
pared from a v
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