ASTM F2382-04(2010)
(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 via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/AAMI/ISO 10993-4.
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 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.6 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: F2382 − 04 (Reapproved 2010)
Standard Test Method for
Assessment of Intravascular Medical Device Materials on
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.
1. Scope 2. Referenced Documents
2.1 ANSI Standard:
1.1 This test method covers the screening of cardiovascular
ANSI/AAMI/ISO10993-4 BiologicalEvaluationofMedical
device materials for their ability to induce blood coagulation
Devices—Part 4: Selection of Tests for Interactions with
via the intrinsic coagulation pathway.This assay should be part
Blood
of the hemocompatibility evaluation for devices and materials
2.2 Other Document:
contacting human blood, as per ANSI/AAMI/ISO 10993-4.
Centers for Disease Control/National Institutes of Health
1.2 All safety policies and practices shall be observed
Manual Biosafety in Microbiological Laboratories, 1999
during the performance of this test method.
3. Terminology
1.3 All plasma and any materials that had contact with
plasma will be bagged in a biohazard bag, properly labeled 3.1 Definitions:
with the contents, and disposed by appropriate means. The 3.1.1 activator—a medical material which demonstrates a
plasma should be handled at the Biosafety Level 2 as recom- shortened clotting time; an initiator of the intrinsic coagulation
mended in the Centers for Disease Control/National Institutes pathway.
of Health Manual Biosafety in Microbiological Laboratories.
3.1.2 partial thromboplastin time (PTT) assay—a modifica-
tion of the Activated Partial Thromboplastin Time (APTT)
1.4 The normal pooled human plasma must have tested
assay; unlike theAPTTtest, the PTTassay uses reagent (rabbit
negative for Hepatitis B (HBV) or Human Immunodeficiency
brain cephalin) without activating substances (silica, kaolin,
(HIV) viruses. The plasmas should be treated like any patient
elagic acid.) The material being tested acts as the activator.
plasma using universal precautions. The plasma should be
handled at the Biosafety Level 2 as recommended in the 3.1.3 read time—the time during which data is collected to
Centers for Disease Control/National Institutes of Health
detect a clot.
Manual Biosafety in Microbiological Laboratories.
3.1.4 blank time—a period at the beginning of an assay
when no data is taken. This is done to eliminate interference
1.5 The values stated in SI units are to be regarded as
from premixing reagents, bubbles, and so forth.
standard. No other units of measurement are included in this
standard. 3.1.5 equilibration time—the time allowed for the plasma
samples to warm to 37°C. The fibrometer can be set to zero if
1.6 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
responsibility of the user of this standard to establish appro- 3.1.6 duplicate flag—the agreement between the results of
duplicate samples in percent. For example, if set to “15,” the
priate safety and health practices and determine the applica-
bility of regulatory limitations prior to use. difference between the two channels must be less than or equal
to 15 %. If the variance in clot times exceeds this percentage,
an asterisk “*” will be printed by the average results on the
report.
This test method is under the jurisdiction ofASTM Committee F04 on Medical
and Surgical Materials and Devices and is the direct responsibility of Subcommittee
F04.16 on Biocompatibility Test Methods. Available from American National Standards Institute (ANSI), 25 W. 43rd St.,
Current edition approved June 1, 2010. Published September 2010. Originally 4th Floor, New York, NY 10036, http://www.ansi.org.
approved in 2004. Last previous edition approved in 2004 as F2382 – 04. DOI: Available from National Institute of Health (NIH), 9000 Rockville Pike,
10.1520/F2382-04R10. Bethesda, MD 20892.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
F2382 − 04 (2010)
4. Significance and Use 8.4 Program the analyzer to test under the APTT function
with an equilibration time of 60 s, activation time of 120 s, a
4.1 The purpose of this test method is to determine the time
blank time of 14 s, and a read time of 286 s.
citrated plasma exposed to medical materials takes to form a
clot when exposed to a suspension of phospholipid particles 8.5 Print out test parameters and verify changes. Photocopy
and calcium chloride. In this test method, the test article is the printout and attach to original data.
activator.The PTTassay is a general screening test for medical
8.6 Pre-warm analysis cuvettes (or cups, dependent on
material’s ability to activate the intrinsic coagulation pathway.
analyzer selected) at 37 6 2°C.
Material samples that show a shortened PTT are activators of
8.7 Pre-warm calcium chloride at 37 6 2°C.
the intrinsic coagulation pathway.
8.8 Rabbit Brain Cephalin (RBC) Preparation:
4.2 TestsamplesthatshowashortenedPTTareactivatorsof
8.8.1 Allow the RBC to come to room temperature.
the intrinsic coagulation pathway. The results are reported as a
8.8.2 Reconstitute RBC with 10 mL reagent grade water/
percent of the negative control. The test article, reference
distilled water.
materials, and controls are exposed to human plasma. The
8.8.3 Place in agitating water bath set at 37 6 2°C, at 60
plasma is tested on a coagulation device. Each sample tube is
rpm for 15 min to ensure complete rehydration of contents.
assayed in duplicate.
8.8.4 Vortex 15 s after rehydration is complete.
8.8.5 Place at 37 6 2°C.
5. Apparatus
8.9 If using frozen blood plasma, quick thaw the plasma at
5.1 Polypropylene Test Tubes with Caps, 12 by 75 mm.
37 6 2°C and place on ice immediately.
5.2 Automatic Pipets and Tips, 100 and 1000 µL.
9. Procedure
5.3 Ice Bath.
9.1 The test material(s), reference material(s), and controls
5.4 Coagulation Analyzer (Automated Fibrometer).
are placed into polypropylene tubes and exposed to the
5.5 Agitating Water Bath, 37 6 2°C, capable of 60 rpm. 2
appropriate quantity of plasma, based on a ratio of 4 cm of
5.6 Coagulation Analyzer Cuvettes, or equivalent for spe-
material to 1 mL plasma. The negative control is a polypro-
cific analyzer. pylene tube with 1 mL of plasma, without additional material.
9.2 The samples are exposed to the plasma for 15 6 1 min
6. Reagents and
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