ASTM F750-87(2012)

NOTICE: This standard has either been superseded and replaced by a new version or withdrawn.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: F750 − 87 (Reapproved 2012)
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.
1. Scope 4. Significance and Use
1.1 This practice covers a nonspecific, acute toxicity test 4.1 This practice is intended to help assess the biocompat-
used for detecting leachables from materials used in medical ibility of materials used in medical devices. It is an acute
devices. toxicological test designed to detect the presence of injurious
leachable substances.
1.2 The liquids injected into the mouse are those obtained
by Practice F619 where the extraction vehicles are saline, 4.2 This practice may not be appropriate for all types of
vegetable oil, or other liquids simulating human body fluids. implant applications. The user is cautioned to consider the
appropriateness of the method in view of the materials being
1.3 Two procedures are outlined: Method A for intravenous
tested, their potential applications, and the recommendations
injection and Method B for intraperitoneal injection.
contained in Practice F748.
1.4 This practice is one of several developed for the
4.3 The only limitation applicable is the extract preparation.
assessment of the biocompatibility of materials. Practice F748
Refer to Sections 4.3 and 4.4 of Practice F619 for a description
may provide guidance for the selection of appropriate methods
of this limitation.
for testing materials for a specific application.
1.5 The values stated in SI units are to be regarded as
5. Apparatus
standard. No other units of measurement are included in this
5.1 Mice—The mice shall be albino-type, healthy and not
standard.
previously used, and shall weigh between 17 and 23 g.Animal
care shall be in accordance with the “Guide for Care and Use
2. Referenced Documents
of Laboratory Animals.” Age, sex, and weight shall be
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
F748 PracticeforSelectingGenericBiologicalTestMethods
minimum of ten mice are used in the test. If the results of this
for Materials and Devices
first test group are inconclusive, then 20 more mice will be
needed to complete the test of one extraction vehicle for one
3. Summary of Practice
plastic.
5.1.1 During the test the mice shall be fed normally with
3.1 The extract liquid is prepared in accordance with Prac-
commercially available feed and tap water.
tice F619. The extraction vehicles are saline and vegetable oil,
or other extraction vehicles, as described in Practice F619. The
5.2 Cages—There shall be one cage for the five mice
extract liquid is injected into mice, and the animals are
exposed to one extract liquid. Each mouse in a cage shall be
observed at regular intervals for 72 h for reactions, survival,
uniquely identified, and this identification shall be recorded.
etc.
Male and female mice shall be housed separately, and their
cages are positioned in a manner which prevents the accidental
transfer of feces or bedding from cage to cage.
This practice is under the jurisdiction ofASTM Committee F04 on Medical and
5.3 Syringe—Sterile syringes, not greater than 3 mL in
Surgical Materials and Devices and is the direct responsibility of Subcommittee
volume, with a precision of 60.10 mL shall be used.
F04.16 on Biocompatibility Test Methods.
5.3.1 MethodA—Sterile needles of 25 to 27 ⁄2 gage shall be
Current edition approved Oct. 1, 2012. Published October 2012. Originally
ε1
approved in 1982. Last previous edition approved in 2007 as F750 – 87 (2007) . used.
DOI: 10.1520/F0750-87R12.
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.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F750 − 87 (2012)
5.3.2 Method B—Sterile needles of 21 to 26 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
extracted matter. If particulates are clearly present, then the
6. Sampling
extract liquids shall be injected by the intraperitoneal method.
Optionally, the pH may be measured and recorded.
6.1 Sample in accordance with Practice F619.
8.1.3 For each extraction vehicle, use ten mice, five for the
7. Sample and Test Specimen sample extract liquid and five for the blank extract liquid.
Weigh all mice, and record their weights. Use a system of
7.1 General—The sample is the plastic or other material
marking to identify each individual mouse within each group
exposed to the extraction procedure. As a result of the
of five.
extraction in Practice F619, for each extraction vehicle there
8.1.4 Inject the predetermined amount (see 7.2.1)ofthe
are available: (1) a sample extract liquid, and (2) a blank
sample extract liquid into the tail vein of each of the five mice.
extract liquid. These extract liquids are to be injected into the
Inject the blank extract liquid in the same way into five other
test animals within 24 h of the end of the extraction procedure.
mice.Theuseofwarmwateroraheatlampmayhelpdilatethe
Record the storage conditions if the liquid extract is not used
tail veins for ease of injection.
immediately after preparation.
8.1.5 Observe all animals immediately after injection, again
7.1.1 There are usually two extract liquids (a blank and a
4 h after injection, and then at 24, 48, and 72 h, respectively,
sample) prepared from an extraction vehicle. Samples based on
after injection for symptoms of slight, moderate, or marked
other extraction vehicles may be available, as described in
toxicity or death (Table 1). Record the observations. Measure
Practice F619, or as required by the standard for the medical
and record the body weights of all animals at 24, 48, and 72 h
device.
post-injection.
7.2 Method A, Intravenous:
7.2.1 The extract liquid is usually prepared from a saline
8.2 Method B, Intraperitoneal:
extract
...