ASTM F2382-04
(Test Method)Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
Standard Test Method for Assessment of Intravascular Medical Device Materials on Partial Thromboplastin Time (PTT)
SCOPE
1.1 This test method covers the screening of cardiovascular device materials for their ability to induce blood coagulation. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood.
1.2 All safety policies and practices shall be observed during the performance of this test method.
1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labeled with the contents, and disposed by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.
1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using universal precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories.
1.5 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 and health practices and determine the applicability of regulatory limitations prior to use.
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Designation: F 2382 – 04
Standard Test Method for
Assessment of Intravascular Medical Device Materials on
Partial Thromboplastin Time (PTT)
This standard is issued under the fixed designation F 2382; 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 3. Terminology
1.1 This test method covers the screening of cardiovascular 3.1 Definitions:
device materials for their ability to induce blood coagulation. 3.1.1 activator—a medical material which demonstrates a
This assay should be part of the hemocompatibility evaluation shortened clotting time; an initiator of the intrinsic coagulation
for devices and materials contacting human blood. pathway.
1.2 All safety policies and practices shall be observed 3.1.2 partial thromboplastin time (PTT) assay—a modifica-
during the performance of this test method. tion of the Activated Partial Thromboplastin Time (APTT)
1.3 All plasma and any materials that had contact with assay; unlike the APTT test, the PTT assay uses reagent (rabbit
plasma will be bagged in a biohazard bag, properly labeled brain cephalin) without activating substances (silica, kaolin,
with the contents, and disposed by appropriate means. The elagic acid.) The material being tested acts as the activator.
plasma should be handled at the Biosafety Level 2 as recom- 3.1.3 read time—the time during which data is collected to
mended in the Centers for Disease Control/National Institutes detect a clot.
of Health Manual Biosafety in Microbiological Laboratories. 3.1.4 blank time—a period at the beginning of an assay
1.4 The normal pooled human plasma must have tested when no data is taken. This is done to eliminate interference
negative for Hepatitis B (HBV) or Human Immunodeficiency from premixing reagents, bubbles, and so forth.
(HIV) viruses. The plasmas should be treated like any patient 3.1.5 equilibration time—the time allowed for the plasma
plasma using universal precautions. The plasma should be samples to warm to 37°C. The fibrometer can be set to zero if
handled at the Biosafety Level 2 as recommended in the samples are pre-warmed to this temperature.
Centers for Disease Control/National Institutes of Health 3.1.6 duplicate flag—the agreement between the results of
Manual Biosafety in Microbiological Laboratories. duplicate samples in percent. For example, if set to “15,” the
1.5 This standard does not purport to address all of the difference between the two channels must be less than or equal
safety concerns, if any, associated with its use. It is the to 15 %. If the variance in clot times exceeds this percentage,
responsibility of the user of this standard to establish appro- an asterisk “*” will be printed by the average results on the
priate safety and health practices and determine the applica- report.
bility of regulatory limitations prior to use.
4. Significance and Use
2. Referenced Documents
4.1 The purpose of this test method is to determine the time
2.1 ANSI Standard: citrated plasma exposed to medical materials takes to form a
ANSI/AAMI/ISO 10993-4 Biological Evaluation of Medi- clot when exposed to a suspension of phospholipid particles
cal Devices—Part 4: Selection of Tests for Interactions and calcium chloride. In this test method, the test article is the
with Blood activator. The PTT assay is a general screening test for medical
2.2 Other Document: material’s ability to activate the intrinsic coagulation pathway.
Centers for Disease Control/National Institutes of Health Material samples that show a shortened PTT are activators of
Manual Biosafety in Microbiological Laboratories, the intrinsic coagulation pathway.
1999 4.2 In this test method, the test sample is the activator. Test
samples that show a shortened PTT are activators of the
This test method 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 May 1, 2004. Published June 2004.
Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
4th Floor, New York, NY 10036.
Available from National Institute of Health (NIH), 9000 Rockville Pike,
Bethesda, MD 20892.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959, United States.
F2382–04
intrinsic coagulation pathway. The results are reported as a 8.9 If using frozen blood plasma, quick thaw the plasma at
percent of the negative control. The test article, reference 37 6 2°C and place on ice immediately.
materials, and controls are exposed to human plasma. The
9. Procedure
plasma is tested on a coagulation device. Each sample tube is
assayed in duplicate.
9.1 The test material(s), reference material(s), and controls
are placed into polypropylene tubes and exposed to the
5. Apparatus 2
appropriate quantity of plasma, based on a ratio of 4 cm of
5.1 Polypropylene Test Tubes with Caps,12by75mm.
material to 1 mL plasma. The negative control is a polypropy-
5.2 Automatic Pipets and Tips, 100 and 1000 μL.
lene tube with 1 mL of plasma, without additional material.
5.3 Lyophilized Rabbit Brain Cephalin (RBC).
9.2 The samples are exposed to the plasma for 15 6 1 min
5.4 Ice Bath.
ina37 6 2°C agitating water bath at 60 rpm.
5.5 Coagulation Analyzer (Automated Fibrometer).
9.3 After 15 min incubation of samples, the tubes are
5.6 Agitating Water Bath,37 6 2°C, capable of 60 rpm.
immediately placed into the ice bath and immediately trans-
5.7 Coagulation Analyzer Cuvettes, or equivalent for spe-
ferred into pre-chilled new polypropylene tubes.
cific analyzer.
9.4 Vortex each sample 15 s before each use/run.
9.5 Avoiding bubbles, transfer 100 μL of the plasma into
6. Reagents and Materials
pre-warmed cuvettes and allow the plasma to equilibrate for 60
6.1 Calcium Chloride,25mm.
sat37 6 2°C.
6.2 Citrated Human Blood Plasma, fresh (less than 4 h from
9.6 To each cuvette/cup, add 100 μL warmed RBC prepa-
draw) or freshly-frozen, maintained at minus 80°C, pooled.
ration initiating the 2 min activation step. (Invert RBC to mix
6.3 Reference Control Material, see Appendix X1.
prior to each use.)
6.4 Positive C
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