ASTM E734-80(2021)

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

• Status: Published
• Publication Date: 31-Dec-2020
• ICS: 11.100.30 - Analysis of blood and urine
• Technical Committee: E41 - Laboratory Apparatus
• Drafting Committee: E41.01 - Laboratory Ware and Supplies

Relations

• Refers: ASTM E438-92(2024) - Standard Specification for Glasses in Laboratory Apparatus
• Effective Date: 01-Feb-2024
• Refers: ASTM E438-92(2018) - Standard Specification for Glasses in Laboratory Apparatus
• Effective Date: 01-Jan-2018
• Refers: ASTM E438-92(2011) - Standard Specification for Glasses in Laboratory Apparatus
• Effective Date: 01-Dec-2011
• Refers: ASTM E438-92(2006) - Standard Specification for Glasses in Laboratory Apparatus
• Effective Date: 01-Nov-2006
• Refers: ASTM E438-92(2001)e1 - Standard Specification for Glasses in Laboratory Apparatus
• Effective Date: 15-Aug-1993
• Refers: ASTM E438-92(1996) - Standard Specification for Glasses in Laboratory Apparatus
• Effective Date: 15-Aug-1993

Overview

ASTM E734-80(2021): Standard Specification for Disposable Glass Blood Sample Capillary Tube (Microhematocrit) defines the requirements for single-use glass capillary tubes employed in microhematocrit procedures for blood analysis. Issued by ASTM International, this standard ensures that capillary tubes-critical in laboratory and clinical diagnostics-meet precise criteria for design, materials, performance, and quality. These tubes are fundamental in hematology for determining patient hematocrit values, thus supporting accurate, safe, and repeatable laboratory measurements.

Key Topics

• Tube Types: The standard specifies two kinds of blood sample capillary tubes:

  • Type I: Heparin-coated (identifiable by a red band), suitable for preventing blood coagulation.
  • Type II: Uncoated (identifiable by a blue band), intended for use where anticoagulants are unnecessary.

• Materials: Capillary tubes are to be made from either:

  • Type I, Class B borosilicate glass, or
  • Type II soda lime glass, meeting requirements outlined in ASTM E438 for laboratory glassware.

• Heparin Coating: For Type I tubes, the ammonium salt of heparin must derive from beef or pork origin and conform to strict potency requirements.

• Physical Requirements:

  • Tubes must be straight, with uniform bore, open at both ends, and free from cracks or significant defects.
  • Dimensional tolerances are controlled for length, inner diameter, and wall thickness.

• Color Coding and Traceability: Each tube must have color coding and batch or control numbers that enable full traceability of manufacturing and raw material history.

• Performance Tests:

  • Capillarity (ability to draw blood or plasma)
  • Fluidity (for Type I, to verify anticoagulant effect)
  • Resistance to centrifugal force
  • Heparin potency and content assays

Applications

Disposable glass blood sample capillary tubes covered by ASTM E734-80(2021) are widely used in clinical and research laboratories for:

• Microhematocrit Procedures: Essential for measuring the proportion of red blood cells in blood, a key diagnostic marker for anemia and other health conditions.
• Blood Collection and Handling: Well-suited for small volume blood draws, particularly in pediatric, neonatal, and point-of-care settings.
• Compatibility: Designed for use with popular centrifugation and microhematocrit test equipment, aligning with internationally recognized laboratory processes.

Using standard-compliant capillary tubes enhances the accuracy, repeatability, and safety of blood testing, ensuring results are reliable and recognized globally.

Related Standards

For comprehensive laboratory and quality assurance, users of ASTM E734-80(2021) often reference additional standards and guidelines, such as:

• ASTM E438: Specification for Glasses in Laboratory Apparatus
• United States Pharmacopeia (USP): Referenced for heparin assay and performance validation
• ISO and WHO guidelines: For laboratory equipment and procedures that intersect with microhematocrit analysis
• Good Laboratory Practice (GLP): General requirements for traceability, documentation, and safety

Keywords: disposable glass capillary tubes, microhematocrit standard, ASTM E734, blood sample tube, heparin-coated capillary, laboratory consumables, clinical hematology supplies

Ensuring compliance with ASTM E734-80(2021) supports both patient safety and laboratory quality, making this standard a key reference for medical device procurement, laboratory accreditation, and regulatory compliance.

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 [e-mail]. 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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