ASTM E1093-91(2019)

Standard Specification for Glass Prothrombin Pipet, Disposable

ABSTRACT
This specification covers the physical requirements and corresponding test methods for disposable glass Prothrombin pipets suitable for use in micro techniques for estimating Prothrombin time. The pipet shall be made of Type 1, Class B borosilicate glass, or Type 2 soda lime glass. The physical properties to which the pipets should adhere to are those for design, dimensions, capacity (accuracy and coefficient of variation), graduation lines, pipet nomenclature, blow-out delivery, color coding, marking permanency, and lot control.
SCOPE
1.1 This specification covers a glass disposable Prothrombin pipet suitable for use in micro techniques for estimation of Prothrombin time.  
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 precautionary statement pertains only to the test method portion, Section 8, of this specification. 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, health, and environmental practices and determine the applicability of regulatory limitations prior to use.  
1.4 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-2018
• ICS: 11.100.99 - Other standards related to laboratory medicine
• Technical Committee: E41 - Laboratory Apparatus
• Drafting Committee: E41.01 - Laboratory Ware and Supplies

Relations

• Replaces: ASTM E1093-91(2012) - Standard Specification for Glass Prothrombin Pipet, Disposable
• Effective Date: 01-Jan-2019
• 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(1996) - Standard Specification for Glasses in Laboratory Apparatus
• Effective Date: 15-Aug-1993
• Refers: ASTM E438-92(2001)e1 - Standard Specification for Glasses in Laboratory Apparatus
• Effective Date: 15-Aug-1993

Overview

ASTM E1093-91(2019): Standard Specification for Glass Prothrombin Pipet, Disposable establishes the requirements for high-quality, single-use glass Prothrombin pipets. Developed by ASTM, this international standard specifies essential physical properties, material types, design features, and quality control measures for disposable glass pipets used in micro techniques to estimate Prothrombin time in laboratory settings. The standard ensures pipets are manufactured to deliver consistent accuracy, safety, and usability, supporting precise laboratory analysis and reliable diagnostic results.

Key Topics

• Material Requirements: Specifies that pipets must be manufactured from either Type 1, Class B borosilicate glass or Type 2 soda lime glass, ensuring chemical resistance and mechanical strength.

• Dimensional Standards: Details strict tolerances for pipet diameter, length, and uniformity of bore to support consistent performance and fit for purpose in micro methods.

• Capacity and Accuracy: Mandates calibration "to deliver" (T.D.) 0.1 mL and 0.2 mL at 20 °C, with set limits for volumetric accuracy and coefficient of variation to enhance measurement reliability.

• Graduation and Markings: outlines requirements for precise graduation lines at 0.1 mL and 0.2 mL, color coding as per ISO 1769, and durable black numerical markings for easy identification.

• Design & Safety: Requires pipets be made from a one-piece glass tube, finished with fire-polished ends for safety and usability, and incorporates features such as blow-out delivery bands for clear operational guidance.

• Marking Permanency and Lot Control: Ensures markings withstand normal handling and use, and requires lot control numbers on packaging for traceability to the raw material source.

Applications

• Clinical Laboratories: Disposable glass Prothrombin pipets are critical in coagulation testing protocols, especially for accurately determining Prothrombin time during blood clotting studies.

• Research Facilities: Widely used in biomedical research, especially for micro volume handling where precise fluid measurement is essential.

• Medical Device Manufacturing: Provides benchmarks for product quality, assisting manufacturers in meeting regulatory, quality, and safety requirements for laboratory glassware.

• Quality Assurance Programs: Laboratories implementing quality management systems rely on this standard for routine validation and verification of disposable glass pipet performance.

• Training and Standard Operating Procedures: Serves as a reference document for educational and operational guides ensuring consistent usage and safety practices in laboratory environments.

Related Standards

• ASTM E438: Specification for Glasses in Laboratory Apparatus - referenced for types of glass required for pipet manufacture.

• ISO 1769: Laboratory Glassware - Pipettes - Color Coding - referenced for standardized identification of pipet capacities by color bands.

• General Laboratory Glassware Standards: Aligns with broader standards on laboratory equipment to ensure cross-compatibility and repeatability.

Practical Value

The implementation of ASTM E1093-91(2019) aids laboratories and manufacturers worldwide in assuring the consistent quality, reliability, and safety of disposable glass Prothrombin pipets. Adhering to this standard streamlines laboratory workflows, supports compliance with internationally recognized practices, and helps align with regulatory requirements in the medical and research sectors.

Keywords: disposable glass Prothrombin pipet, laboratory pipette standard, coagulation testing, Prothrombin time, ASTM E1093, laboratory glassware, accuracy, lot control, ISO color coding, clinical laboratory standards.

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: E1093 −91 (Reapproved 2019)
Standard Specification for
Glass Prothrombin Pipet, Disposable
This standard is issued under the fixed designation E1093; 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 3.1.2 coeffıcient of variation—the expected distribution of
individual volumes around the mean volume.
1.1 ThisspecificationcoversaglassdisposableProthrombin
3.1.3 disposable—Prothrombin pipets which are intended to
pipet suitable for use in micro techniques for estimation of
be used once only and then discarded.
Prothrombin time.
1.2 The values stated in SI units are to be regarded as NOTE 1—Such pipets will only be expected to provide their specified
performance during the original operation.
standard. No other units of measurement are included in this
standard.
4. Classification
1.3 This precautionary statement pertains only to the test
4.1 This specification covers only one glass pipet as illus-
method portion, Section 8, of this specification. This standard
trated in Fig. X1.1.
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
5. Materials and Manufacture
standard to establish appropriate safety, health, and environ-
5.1 The pipet shall be made of borosilicate glass, Type 1;
mental practices and determine the applicability of regulatory
Class B, or soda lime glass, Type 2, in accordance with
limitations prior to use.
Specification E438.
1.4 This international standard was developed in accor-
dance with internationally recognized principles on standard-
6. Physical Properties
ization established in the Decision on Principles for the
Development of International Standards, Guides and Recom- 6.1 Design—The Prothrombin pipet shall be made of one
piececonstructionglasstubingthatisstraightandwithuniform
mendations issued by the World Trade Organization Technical
Barriers to Trade (TBT) Committee. bore and lightly firepolished on both ends. The pipet shall be
made to the dimensions as specified in Fig. X1.1.
2. Referenced Documents
6.2 Dimensions—The pipet shall be made of tubing with a
2.1 ASTM Standards:
minimum outside diameter (o.d.) of 2.3 mm with an inside
E438 Specification for Glasses in Laboratory Apparatus
diameter (i.d.) of 1.7 mm. The uniformity of the bore shall be
2.2 ISO Standard:
60.05 mm throughout the straight portion of the pipet. The
1769 Laboratory Glassware—Pipettes—Color Coding
pipet shall be a minimum of 160 mm long.
6.3 Capacity—The pipet shall be calibrated “to deliver”
3. Terminology
(T.D.) 0.1 and 0.2 mL at 20 °C. Marking shall be as specified
3.1 Definitions of Terms Specific to This Standard:
in 6.5.
3.1.1 accuracy—the expected distribution of mean volumes
6.3.1 Accuracy (see 3.1.1)—The accuracy from stated vol-
around the stated volume.
ume shall be 62.0 % for the 0.1 and 0.2-mLcapacity and shall
be determined as specified in 8.1.
6.3.2 Coeffıcient of Variation (see 3.1.2)—The coefficient of
This specification is under the jurisdiction of ASTM Committee E41 on
variation from stated volume for the 0.1 and 0.2-mL capacity
Laboratory Apparatus and is the direct responsibility of Subcommittee E41.01 on
Laboratory Ware and Supplies.
shall not exceed 2.0 % and shall be determined as specified in
Current edition approved Jan. 1, 2019. Published January 2019. Originally
8.1.
approved in 1986. Last previous edition approved in 2012 as E1093 – 91(2012).
DOI: 10.1520/E1093-91R19.
6.4 Graduation Lines—The pipet shall be calibrated and
For referenced ASTM standards, visit the ASTM website, www.astm.org, or
marked with graduation lines at 0.1 and 0.2 mLfrom the tip of
contact ASTM Customer Service at [e-mail]. For Annual Book of ASTM
the pipet.The graduation lines shall be 0.3 6 0.1 mm and shall
Standards volume information, refer to the standard’s Document Summary page on
the ASTM website. completely encircle the tube.
Available from International Organization for Standardization (ISO), ISO
6.5 Pipet Nomenclature—The pipet shall be marked with
Central Secretariat, BIBC II, Chemin de Blandonnet 8, CP 401, 1214 Vernier,
Geneva, Switzerland, http://www.iso.org. 0.1 and 0.2-mL markings slightly above the graduation lines.
Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States
E1093 − 91 (2019)
The pipet may be marked with the inscription T.D. 20 °C, or 8.2 Calculation—Calculate the volume, V, of a micropipet
the manufacturer’s or vendor’s name or trademark, or both. from the weighings, in air, as follows:
6.6 Blow-out Delivery—The Prothrombin pipet is designed V 5 W 3Z (1)
as a dual delivery system for the determinations of coagulation
where:
assays.Whenutilizingthe0.2mLcalibrationline,thetipofthe
W = apparent mass of liquid (water), weighed in air, and
pipet should contact the wall of the receiving vessel and allow
Z = apparent specific volume of liquid (water).
the pipet to drain freely. The remaining quantity of liquid is to
Values of Z for water are given in the appendix.
be blown out into the center of the receiving vessel. When
utilizing the 0.1 mL calibration line the contents are t
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