ASTM E1046-85(2021)

Standard Specification for Glass Westergren Tube, Disposable

ABSTRACT
This specification covers a disposable glass Westergren tube used for measuring the erythrocyte sedimentation rate. Covered by this specification are Type I (standard Westergren tube used in conventional racks only) and Type II (self-zeroing tubes used with racks that have convenient disposable tube features) Westergren tubes. The tubes shall be manufactured from borosilicate glass (Type I, Class B) or soda lime glass (Type II) into a one-piece construction that is free from visible defects, straight, and of uniform bore, with the ends of the tube cut at right angles to the tube axis and fire polished. In addition, Type II tubes shall be inserted wit an absorbent cotton plug. The tube shall be graduated, with graduation lines at right angles to the tube axis and in units of millimeters.
SCOPE
1.1 This specification covers a disposable tube used for measuring the erythrocyte sedimentation rate, ESR (the suspension stability of red cells in diluted, anti-coagulated human blood).  
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: 11.100.99 - Other standards related to laboratory medicine
• 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 E1046-85(2021) is the internationally recognized standard specification for disposable glass Westergren tubes. Developed by ASTM, this standard sets the requirements for tubes used to measure the erythrocyte sedimentation rate (ESR) in clinical laboratory settings. The ESR is a vital hematology test that assesses the suspension stability of red blood cells in diluted, anti-coagulated human blood. Correct ESR measurement relies on consistent tube quality, dimensional accuracy, and material properties - all enforced by this specification.

Key Topics

• Types of Westergren Tubes:

  • Type I: Standard Westergren tubes, designed exclusively for use in conventional racks.
  • Type II: Self-zeroing Westergren tubes for racks engineered with features to accommodate disposable options.

• Materials and Construction:

  • Type I tubes are made from Type I, Class B borosilicate glass for chemical durability and stability.
  • Type II tubes utilize soda lime glass with an absorbent cotton plug precisely positioned to aid measurement.
  • All tubes are of single-piece construction, free from visible defects, featuring straight uniform bores and fire-polished ends.

• Graduations and Markings:

  • Tubes are graduated in millimeters, with lines at right angles to the tube axis.
  • Graduation lines must be consistent and within strict tolerances to ensure measurement accuracy.
  • Markings start at zero and continue to at least 180 or 190 mm, clearly inscribed for readability.

• Dimensional Consistency:

  • The uniform bore ensures reproducible ESR test results.
  • Tubes typically range from 230 mm to 243 mm in length (Type II), with a strict length tolerance of ±1 mm.

• Disposable Usage:

  • Intended for single-use only to prevent cross-contamination and ensure test reliability.
  • Reusing disposable tubes is not recommended and is the sole responsibility of the user.

Applications

• Clinical Laboratories: The primary application is in medical laboratories for ESR testing, which helps diagnose and monitor conditions such as inflammation, infection, and autoimmune disorders.
• Diagnostic Facilities: Used in both hospital and independent labs where standardized ESR testing methods are required.
• Quality Control: Laboratories aligned with ASTM E1046-85(2021) ensure greater consistency, traceability, and international compliance, especially important for accreditation purposes.
• Research: ESR analysis is also relevant in biomedical research involving blood sedimentation rates.

Related Standards

For laboratories and manufacturers referencing ASTM E1046-85(2021), the following related standards may also be relevant:

• ASTM E438 - Specification for Glasses in Laboratory Apparatus, which details the properties required for both borosilicate and soda lime glass types.
• ISO 15189 - Medical laboratories - Requirements for quality and competence, relevant for laboratories seeking international recognition.
• CLSI Guidelines - Clinical and Laboratory Standards Institute guidelines for ESR measurement methods.

Conclusion

Adhering to ASTM E1046-85(2021) ensures that disposable glass Westergren tubes used for ESR measurement are safe, reliable, and meet rigorous international quality standards. Standardized tube properties and construction support accurate clinical diagnostics and laboratory efficiency, contributing to better patient care and laboratory accreditation. For manufacturers and laboratories, compliance with this standard demonstrates a commitment to quality, safety, and regulatory best practices in medical laboratory testing.

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: E1046 −85 (Reapproved 2021)
Standard Specification for
Glass Westergren Tube, Disposable
This standard is issued under the fixed designation E1046; 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 that is described in other published standards. The tubes shall
be of the following types:
1.1 This specification covers a disposable tube used for
4.1.1 Type I—standard Westergren tube to be used in con-
measuring the erythrocyte sedimentation rate, ESR (the sus-
ventional racks only, and
pension stability of red cells in diluted, anti-coagulated human
4.1.2 Type II—self-zeroing tubes to be used with racks
blood).
designed with convenient disposable tube features.
1.2 The values stated in SI units are to be regarded as
standard. No other units of measurement are included in this
5. Materials
standard.
5.1 Glass—The tubes made to this specification shall be
1.3 This international standard was developed in accor-
fabricatedfromborosilicateglass,TypeI,ClassB,orsodalime
dance with internationally recognized principles on standard-
glass, Type II, in accordance with Specification E438.
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- 6. Physical Requirements
mendations issued by the World Trade Organization Technical
6.1 Design, Type I and II—The Westergren tube shall be
Barriers to Trade (TBT) Committee.
made of one-piece construction from tubing that is straight and
of uniform bore. The ends of the tube shall be cut at right
2. Referenced Documents
angles to the axis of the tube and fire polished.
2.1 ASTM Standards:
6.1.1 Type II only—Eachtubeshallhaveanabsorbantcotton
E438 Specification for Glasses in Laboratory Apparatus
plug inserted in the tube with the bottom edge of the plug
3. Terminology aligned with the 0 mm calibration line. The alignment of the
plug to the calibration line should not vary by more than 1 mL.
3.1 Definitions of Terms Specific to This Standard:
The plug must be capable of supporting a 200 mm vertical
3.1.1 disposable, n—in accordance with this specification
column of water when the plug has been thoroughly soaked.
and the expected product performance expressed in this
standard, those tubes which are to be used one time only. Any
NOTE 1—With possible printing scale variation and cotton plug
alignment to the calibration line variation, the bottom of the cotton plug is
institution or individual who resuses a disposable tube must
to be located 200 6 1 mm from the bottom of the tube.
bear full responsibility for its safety and effectiveness.
6.2 Workmanship—The tube shall be free as possible from
3.1.2 Westergren , n—surname of the individual responsible
visible defects which would detract from its appearance or
for the design of the reusable Westergren tube and the method
impair its serviceability when viewed by the human eye under
of use for both reusable and disposable tubes.
normal room lighting. Self-zeroing tubes are to be used with
4. Classification
racks designed with convenient disposable tube features.
4.1 This specification covers a tube that is intended to be
6.3 Dimensions—Dimensions and tolerances shall be in
used one time only. It is not to be
...