ASTM E734-80(2021)
(Specification)Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit)
Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit)
ABSTRACT
This specification describes the physical requirements and corresponding test methods for disposable glass blood sample capillary tubes for use in microhematocrit procedures. Covered here are two different types of capillary tubes, namely, Type I (coated with heparin), and Type II (uncoated). The tubes shall be fabricated from Type I, Class B borosilicate glass, or Type II soda lime glass. Conversely, the heparin used for coating Type I tubes shall be of ammonium salt isolated from the lungs or intestinal mucosa of beef or pork origin. The tubes shall conform to specified requirements for design, dimension, workmanship, color coding, and lot or control number. They should also pass the following tests for capillarity, fluidity, sheep plasma, positive and negative controls, human whole blood, heparin potency assay, and resistance to centrifugal force.
SCOPE
1.1 This specification covers disposable glass blood sample capillary tubes for use in microhematocrit procedures.
1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.3 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
General Information
Relations
Standards Content (Sample)
This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the
Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.
Designation: E734 −80 (Reapproved 2021)
Standard Specification for
Disposable Glass Blood Sample Capillary Tube
(Microhematocrit)
This standard is issued under the fixed designation E734; the number immediately following the designation indicates the year of
original adoption or, in the case of revision, the year of last revision.Anumber in parentheses indicates the year of last reapproval.A
superscript epsilon (´) indicates an editorial change since the last revision or reapproval.
1. Scope Type II—Uncoated.
1.1 This specification covers disposable glass blood sample
5. Materials
capillary tubes for use in microhematocrit procedures.
1.2 The values stated in SI units are to be regarded as 5.1 Glass—The pipets made to this specification shall be
standard. No other units of measurement are included in this fabricated from borosilicate glass, Type I, Class B, or soda-
standard. lime glass, Type II, in accordance with Specification E438.
1.3 This international standard was developed in accor-
5.2 Heparin—Heparin shall be of ammonium salt isolated
dance with internationally recognized principles on standard-
from the lungs or intestinal mucosa of beef or pork origin.The
ization established in the Decision on Principles for the
heparin potency shall be 1 mg of ammonium heparin com-
Development of International Standards, Guides and Recom-
pound which shall be equal to at least 60 United States
mendations issued by the World Trade Organization Technical
Pharmacopeia (USP) units. Dry or wet heparin may be applied
Barriers to Trade (TBT) Committee.
to the tube.
2. Referenced Documents
6. Physical Requirements
2.1 ASTM Standards:
E438Specification for Glasses in Laboratory Apparatus 6.1 Design—The capillary tubes shall be straight and open
2.2 Other Standard: atbothendswithoutliporconstriction.Thecapillarytubemay
USP XIX United States Pharmacopeia belightlyfirepolishedononeend.Theboreofthetubeshallbe
uniform and not vary in excess of 0.025 mm in 75 mm.
3. Terminology
6.2 Dimensions—Type I and Type II capillary tubes shall
3.1 Definitions of Terms Specific to This Standard:
have a length of 75 6 0.5 mm. Inside diameter shall be from
3.1.1 disposable capillary tubes, n—in accordance with this
1.07 to 1.24 mm. Wall thickness shall be 0.20+0.03,−0.02
specification and the expected product performance expressed
mm, as specified in Fig. 1.
in this standard, those capillary tubes which are to be used one
time only. Any institution or individual who reuses a dispos-
6.3 Workmanship—The capillary tubes shall be free of
able capillary tube must bear full responsibility for its safety
defects that noticeably detract from their appearance or impair
and effectiveness.
their serviceability. The capillary tube shall be free of lint, or
significant foreign matter, loose or embedded, when viewed
4. Classification
under normal room lighting. The tube ends shall be cut
4.1 This specification covers two different disposable glass
approximately 90° to the tube axis and shall not be cracked or
sample capillary tubes as follows:
have jagged ends or chips that enter the bore of the tubing.
Type I—Coated with heparin.
6.4 Color Coding—Each capillary tube shall be color coded
to identify the tube as coated with heparin or uncoated.Type I,
This specification is under the jurisdiction of ASTM Committee E41 on
heparin coated, shall have a red band and Type II, uncoated,
Laboratory Apparatus and is the direct responsibility of Subcommittee E41.01 on
shall have a blue band. The location of the red or blue band
Laboratory Ware and Supplies.
Current edition approved Jan. 1, 2021. Published February 2021. Originally
shall be as specified in Fig. 1.
approvedin1980.Lastpreviouseditionapprovedin2015asE734–80(2015).DOI:
10.1520/E0734-80R21.
6.5 Capillarity—The capillary tube shall be capable of
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
drawing sheep plasma or human whole blood to a level within
contact ASTM Customer Service at service@astm.org. For Annual Book of ASTM
20 mm from the far end of the tube when tested as specified in
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. 7.1.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E734 − 80 (2021)
FIG. 1 Type I and Type II Capillary Tubes
6.6 Fluidity(TypeI,Heparinized,only)—Coagulationofthe 7.3.Astatementonexpectedunitsofheparinandanexpiration
sheepplasmaorhumanwholebloodshallnotbeevidentwhen date may be claimed by the manufacturer. This option may be
viewed under normal room lighting and tested as specified in expressed on the label.
7.2.
7. Test Methods
6.7 Lot or Control Number—A lot or control number shall
be indicated on the capillary tube unit container and on the
7.
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