ASTM E1045-00(2022)

Standard Specification for Pipet, Sahli Hemoglobin

ABSTRACT
This specification covers reusable Sahli hemoglobin pipets. The pipets shall be made of common spirit bore white back tubing. Pipet design shall be straight and of one-piece construction. Pipet delivery tips shall be made with a gradual or concave taper. Pipet dimensions shall be within tolerance limit indicated in this specification. The pipet shall have markings which include graduation line, volumetric designation, identification, and capacity deviation. Testing methods include capacity test, capacity deviation, pigmentation test, and strain free test.
SCOPE
1.1 This specification covers reusable pipets calibrated “to contain” 20 cmm of whole blood and used for hemoglobin determinations.  
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-2021
• 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 E920-97(2019) - Standard Specification for Commercially Packaged Laboratory Apparatus
• Effective Date: 01-Jul-2019
• Refers: ASTM E920-97(2013) - Standard Specification for Commercially Packaged Laboratory Apparatus
• Effective Date: 01-Nov-2013
• Refers: ASTM E1157-87(2011) - Standard Specification for Sampling and Testing of Reusable Laboratory Glassware
• Effective Date: 01-Dec-2011
• Refers: ASTM E1157-87(2018)e1 - Standard Specification for Sampling and Testing of Reusable Laboratory Glassware
• Effective Date: 01-Dec-2011
• Refers: ASTM E1133-86(2010) - Standard Practice for Performance Testing of Packaged Laboratory Apparatus for United States Government Procurements
• Effective Date: 01-Sep-2010
• Refers: ASTM E921-97(2010) - Standard Specification for Export Packaged Laboratory Apparatus
• Effective Date: 15-May-2010
• Refers: ASTM E920-97(2008) - Standard Specification for Commercially Packaged Laboratory Apparatus
• Effective Date: 01-Nov-2008
• Refers: ASTM E1157-87(2006) - Standard Specification for Sampling and Testing of Reusable Laboratory Glassware
• Effective Date: 01-Nov-2006
• Refers: ASTM E1133-86(2005) - Standard Practice for Performance Testing of Packaged Laboratory Apparatus for United States Government Procurements
• Effective Date: 01-Oct-2005
• Refers: ASTM E1133-86(2000) - Standard Practice for Performance Testing of Packaged Laboratory Apparatus for United States Government Procurements
• Effective Date: 01-Jan-2000
• Refers: ASTM E1133-86(1996)e1 - Standard Practice for Performance Testing of Packaged Laboratory Apparatus for United States Government Procurements
• Effective Date: 01-Jan-2000
• Refers: ASTM E920-97(2003) - Standard Specification for Commercially Packaged Laboratory Apparatus
• Effective Date: 10-Nov-1997
• Refers: ASTM E921-97(2003) - Standard Specification for Export Packaged Laboratory Apparatus
• Effective Date: 10-Nov-1997
• Refers: ASTM E1157-87(1996) - Standard Specification for Sampling and Testing of Reusable Laboratory Glassware
• Effective Date: 10-Oct-1996
• Refers: ASTM E920-97 - Standard Specification for Commercially Packaged Laboratory Apparatus
• Effective Date: 01-Jan-1996

Overview

ASTM E1045-00(2022): Standard Specification for Pipet, Sahli Hemoglobin establishes requirements for reusable Sahli hemoglobin pipets. These laboratory pipets are crucial for hemoglobin determinations, especially in clinical and research settings involving blood analysis. The standard outlines material specifications, construction features, dimensional tolerances, required markings, and testing methods to ensure reliable and accurate measurements. Developed in line with internationally recognized principles, this standard supports quality, repeatability, and traceability in medical laboratory practices worldwide. All values within this standard are stated exclusively in SI units, underpinning consistency in global laboratory operations.

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Key Topics

• Material and Construction

  • Pipets must be crafted from spirit bore white back tubing or clear glass with a white stripe.
  • The design is straight and constructed from a single piece, enhancing durability and ease of cleaning.
  • Cross sections must be circular, supporting accurate volumetric delivery.

• Design and Dimensions

  • Delivery tips must feature a gradual or concave taper, with tips ground or fire-polished for uniform sample delivery.
  • Tolerances for length and dimensions are specified, ensuring pipets are fit for Hemoglobin measurement procedures.

• Calibration and Marking

  • Each pipet is calibrated to contain 20 cubic millimeters (cmm) of whole blood.
  • Graduation lines, volumetric designation, manufacturer identification, and capacity deviation are permanently marked, typically in black or amber, ensuring easy visual verification and traceability.

• Testing Requirements

  • Pipets undergo rigorous performance evaluations, including:
    • Capacity tests (using distilled water and precision weighing equipment)
    • Capacity deviation measurement
    • Pigmentation test to ensure marks do not discolor from cleaning
    • Strain-free verification using polariscope analysis

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Applications

Reusable Sahli hemoglobin pipets specified by ASTM E1045-00(2022) are utilized primarily in:

• Clinical laboratories conducting blood hemoglobin determinations for patient diagnostics.
• Research institutions studying hematological disorders or developing new analytical techniques for blood assays.
• Medical device manufacturers producing laboratory apparatus according to recognized quality standards.
• Quality control settings where traceability, measurement accuracy, and repeatability are critical.

The robust testing and marking requirements defined in ASTM E1045-00(2022) ensure that pipets deployed in blood analysis deliver confidence in measurement results and uphold laboratory best practices.

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Related Standards

Users of ASTM E1045-00(2022) should also consider the following relevant ASTM standards to maintain comprehensive compliance and performance in laboratory settings:

• ASTM E920: Specification for Commercially Packaged Laboratory Apparatus
• ASTM E921: Specification for Export Packaged Laboratory Apparatus
• ASTM E1133: Practice for Performance Testing of Packaged Laboratory Apparatus for United States Government Procurements
• ASTM E1157: Specification for Sampling and Testing of Reusable Laboratory Glassware

Compliance with these related standards helps ensure that Sahli hemoglobin pipets are not only manufactured to mandated specifications but also reliably packaged, sampled, and tested for consistent performance across the laboratory supply chain.

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For laboratories and manufacturers seeking quality assurance, ASTM E1045-00(2022) offers a comprehensive, internationally recognized framework for the specification and verification of reusable Sahli hemoglobin pipets, supporting diagnostic accuracy and global best practices in laboratory medicine.

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: E1045 −00 (Reapproved 2022)
Standard Specification for
Pipet, Sahli Hemoglobin
This standard is issued under the fixed designation E1045; 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 4.2 Delivery Tips—Delivery tips shall be made with a
gradual or concave taper to a length of 10 to 25 mm. The tip
1.1 This specification covers reusable pipets calibrated “to
end shall be ground and tapered with fine abrasive, or fire-
contain” 20 cmm of whole blood and used for hemoglobin
polished.Dimensionsofthedeliverytipshallbeasspecifiedin
determinations.
Fig. 1.
1.2 The values stated in SI units are to be regarded as
4.3 Thetopofthepipetshallbegroundtoataperorformed
standard. No other units of measurement are included in this
to a funnel shape according to the dimensions specified in Fig.
standard.
1.
1.3 This international standard was developed in accor-
dance with internationally recognized principles on standard-
5. Markings
ization established in the Decision on Principles for the
5.1 Graduation Line—The pipet shall have one graduation
Development of International Standards, Guides and Recom-
line located 20 cmm from the pipet tip. The graduation line
mendations issued by the World Trade Organization Technical
shall be located on the clear portion of the tubing and shall
Barriers to Trade (TBT) Committee.
extend at least two thirds around the pipet and not exceed 0.4
mm in width.
2. Referenced Documents
2.1 ASTM Standards: 5.2 Volumetric Designation—The pipet shall be marked
E920Specification for Commercially Packaged Laboratory 20CMM on the clear portion of the tubing with the markings
Apparatus located approximately 5 mm above the graduation line.
E921Specification for Export Packaged Laboratory Appa-
5.3 Identification—Each pipet shall be marked with the
ratus
manufacturer’s name or trademark on the white stripe portion
E1133Practice for Performance Testing of Packaged Labo-
of the pipet. Catalog number markings are optional. All
ratory Apparatus for United States Government Procure-
markings shall be permanently fused onto the pipet. The
ments
markings shall be amber or black in color. When tested in
E1157Specification for Sampling and Testing of Reusable
accordance to 6.3, the pigmentation shall not discolor. The
Laboratory Glassware
appearance of the markings, when viewed by the eye under
normal room lighting, shall be the same before and after
3. Materials
testing.
3.1 The pipets shall be made of common spirit bore white
5.4 Capacity Deviation—SahliHemoglobinpipetsaremade
back tubing or of clear glass with a white stripe applied to the
with maximum capacity deviation of 61.0% or 62.0%. The
outer surface of the tubing.
selected capacity deviation shall be marked on the clear or
4. Design
whitestripeportionofthepipet.Thecapacityofthepipetshall
4.1 Shape—Pipets shall be straight and of one-piece con-
be within the selected capacity deviation marked on the pipet
struction. Any cross section of a pipet taken in a plane
when tested as specified in 6.2.
perpendicular to the longitudinal axis should be circular.
6. Testing
This specification is under the jurisdiction of ASTM Committee E41 on
6.1 Capacity Test—The capacity of the pipet shall be
Laboratory Apparatus and is the direct responsibility of Subcommittee E41.01 on
determined by means of using distilled water and a weighing
Laboratory Ware and Supplies.
device with weight sensitivity not less than 0.001 mg.
Current edition approved Jan. 1, 2022. Published February 2022. Originally
6.1.1 The pipet shall be thoroughly cleaned, dried, an
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