ASTM F750-87(1996)

NOTICE: This standard has either been superseded and replaced by a new version or discontinued.
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Designation: F 750 – 87 (Reapproved 1996)
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 4.3 The only limitation applicable is the extract preparation.
Refer to Sections 4.3 and 4.4 of Practice F 619 for a description
1.1 This practice covers a nonspecific, acute toxicity test
of this limitation.
used for detecting leachables from materials used in medical
devices.
5. Apparatus
1.2 The liquids injected in the mouse are those obtained by
5.1 Mice—The mice shall be albino-type, healthy and not
Practice F 619 where the extraction vehicles are saline, veg-
previously used, and shall weigh between 17 and 23 g. Animal
etable oil, or other liquids simulating human body fluids.
care shall be in accordance with the “Guide for Care and Use
1.3 Two procedures are outlined: Method A for intravenous
of Laboratory Animals.” Age, sex, and weight shall be
injection and Method B for intraperitoneal injection.
recorded and reported. All the mice for each extraction vehicle
1.4 This practice is one of several developed for the
shall be from the same source. For each extraction vehicle, a
assessment of the biocompatibility of materials. Practice F 748
minimum of ten mice are used in the test. If the results of this
may provide guidance for the selection of appropriate methods
first test group are inconclusive, then 20 more mice are needed
for testing materials for a specific application.
to complete the test of one extraction vehicle for one plastic.
2. Referenced Documents 5.1.1 During the test the mice shall be fed normally with
commercially available feed and tap water.
2.1 ASTM Standards:
2 5.2 Cages—There shall be one cage for the five mice
F 619 Practice for Extraction of Medical Plastics
exposed to one extract liquid. Each mouse in a cage shall be
F 748 Practice for Selecting Generic Biological Test Meth-
2 uniquely identified, and this identification shall be recorded.
ods for Materials and Devices
Male and female mice are housed separately, and their cages
3. Summary of Practice are positioned in a manner which prevents the accidental
transfer of feces or bedding from cage to cage.
3.1 The extract liquid is prepared in accordance with Prac-
5.3 Syringe—Sterile syringes, not greater than 3 mL in
tice F 619. The extraction vehicles are saline and vegetable oil,
volume, with a precision of 6 0.10 mL shall be used.
or other extraction vehicles, as described in Practice F 619. The
5.3.1 Method A—Sterile needles of 25 to 27 ⁄2 gage shall be
extract liquid is injected into mice, and the animals are
used.
observed at regular intervals for 72 h for reactions, survival,
5.3.2 Method B—Sterile needles of 21 to 26 gage shall be
etc.
used.
4. Significance and Use
6. Sampling
4.1 This practice is intended to help assess the biocompat-
6.1 Sample in accordance with Practice F 619.
ibility of materials used in medical devices. It is an acute
toxicological test designed to detect the presence of injurious
7. Sample and Test Specimen
leachable substances.
7.1 General—The sample is the plastic or other material
4.2 This practice may not be appropriate for all types of
exposed to the extraction procedure. As a result of the
implant applications. The user is cautioned to consider the
extraction in Practice F 619, for each extraction vehicle there
appropriateness of the method in view of the materials being
are available: (1) a sample extract liquid, and (2) a blank
tested, their potential applications, and the recommendations
extract liquid. These extract liquids are to be injected into the
contained in Practice F 748.
test animals within 24 h of the end of the extraction procedure.
Record storage conditions if not used immediately after prepa-
This practice is under the jurisdiction of ASTM Committee F-4 on Medical and
ration.
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, 100 Barr Harbor Drive, West Conshohocken, PA 19428-2959, United States.
F 750
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 vegetable oil extraction vehicle. The dose of the 8.2.4 Inject the predetermined amount (see 7.3) of the
extract liquid is 50 mL/kg of body weight
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