ASTM F2382-04e1
(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)
SIGNIFICANCE AND USE
The purpose of this test method is to determine the time citrated plasma exposed to medical materials takes to form a clot when exposed to a suspension of phospholipid particles and calcium chloride. In this test method, the test article is the activator. The PTT assay is a general screening test for medical material’s ability to activate the intrinsic coagulation pathway. Material samples that show a shortened PTT are activators of the intrinsic coagulation pathway.
Test samples that show a shortened PTT are activators of the intrinsic coagulation pathway. The results are reported as a percent of the negative control. The test article, reference materials, and controls are exposed to human plasma. The plasma is tested on a coagulation device. Each sample tube is assayed in duplicate.
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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Standards Content (Sample)
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Designation:F2382–04
Standard Test Method for
Assessment of Intravascular Medical Device Materials on
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Partial Thromboplastin Time (PTT)
This standard is issued under the fixed designation F2382; 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 (´) indicates an editorial change since the last revision or reapproval.
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´ NOTE—Editorial changes were made throughout in July 2004.
1. Scope 2.2 Other Document:
Centers for Disease Control/National Institutes of Health
1.1 This test method covers the screening of cardiovascular
Manual Biosafety in Microbiological Laboratories,
device materials for their ability to induce blood coagulation
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1999
via the intrinsic coagulation pathway.This assay should be part
of the hemocompatibility evaluation for devices and materials
3. Terminology
contacting human blood, as per ANSI/AAMI/ISO 10993-4.
3.1 Definitions:
1.2 All safety policies and practices shall be observed
3.1.1 activator—a medical material which demonstrates a
during the performance of this test method.
shortened clotting time; an initiator of the intrinsic coagulation
1.3 All plasma and any materials that had contact with
pathway.
plasma will be bagged in a biohazard bag, properly labeled
3.1.2 partial thromboplastin time (PTT) assay—a modifica-
with the contents, and disposed by appropriate means. The
tion of the Activated Partial Thromboplastin Time (APTT)
plasma should be handled at the Biosafety Level 2 as recom-
assay; unlike theAPTTtest, the PTTassay uses reagent (rabbit
mended in the Centers for Disease Control/National Institutes
brain cephalin) without activating substances (silica, kaolin,
of Health Manual Biosafety in Microbiological Laboratories.
elagic acid.) The material being tested acts as the activator.
1.4 The normal pooled human plasma must have tested
3.1.3 read time—the time during which data is collected to
negative for Hepatitis B (HBV) or Human Immunodeficiency
detect a clot.
(HIV) viruses. The plasmas should be treated like any patient
3.1.4 blank time—a period at the beginning of an assay
plasma using universal precautions. The plasma should be
when no data is taken. This is done to eliminate interference
handled at the Biosafety Level 2 as recommended in the
from premixing reagents, bubbles, and so forth.
Centers for Disease Control/National Institutes of Health
3.1.5 equilibration time—the time allowed for the plasma
Manual Biosafety in Microbiological Laboratories.
samples to warm to 37°C. The fibrometer can be set to zero if
1.5 This standard does not purport to address all of the
samples are pre-warmed to this temperature.
safety concerns, if any, associated with its use. It is the
3.1.6 duplicate flag—the agreement between the results of
responsibility of the user of this standard to establish appro-
duplicate samples in percent. For example, if set to “15,” the
priate safety and health practices and determine the applica-
difference between the two channels must be less than or equal
bility of regulatory limitations prior to use.
to 15 %. If the variance in clot times exceeds this percentage,
2. Referenced Documents an asterisk “*” will be printed by the average results on the
report.
2.1 ANSI Standard:
ANSI/AAMI/ISO 10993-4 Biological Evaluation of Medi-
4. Significance and Use
cal Devices—Part 4: Selection of Tests for Interactions
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4.1 The purpose of this test method is to determine the time
with Blood
citrated plasma exposed to medical materials takes to form a
clot when exposed to a suspension of phospholipid particles
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This test method is under the jurisdiction ofASTM Committee F04 on Medical
and calcium chloride. In this test method, the test article is the
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
activator.The PTTassay is a general screening test for medical
F04.16 on Biocompatibility Test Methods.
Current edition approved May 1, 2004. Published June 2004. DOI: 10.1520/
F2382-04E01.
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Available fromAmerican National Standards Institute (ANSI), 25 W. 43rd St., Available from National Institute of Health (NIH), 9000 Rockville Pike,
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F2382–04
material’s ability to activate the intrinsic coagulation pathway. 8.8.3 Place in agitating water bath set at 37 6 2°C, at 60
Material samples that show a shortened PTT are activators of rpm for 15 min to ensure complete rehydration of contents.
the intrinsic coagulation pathway. 8.8.4 Vortex 15 s after rehydration is complete.
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