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ASTM E1046-85(2021)

(Specification)

Standard Specification for Glass Westergren Tube, Disposable

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
Current Stage
Ref Project

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

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ASTM E1046-85(2021) - Standard Specification for Glass Westergren Tube, DisposableASTM E1046-85(2021) - Standard Specification for Glass Westergren Tube, Disposable
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ASTM E1046-85(2021) - Standard Specification for Glass Westergren Tube, Disposable
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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
...

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SCOPE
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4.1 The objective of this document is to provide guidance in the production, characterization, testing, and standardization of: (1) polymerizable collagen starting materials; and (2) collagen polymeric materials produced with polymerizable collagen formulations, used for surgical implants, substrates for TEMPs, vehicles for therapeutic cells and molecules, and 3D in-vitro tissue systems for basic research, drug development, and toxicity testing. This guide can be used as an aid in the selection, characterization, and standardization of the appropriate polymerizable collagen starting formulations as well as collagen polymeric materials prepared from polymerizable collagens for a specific use. Not all tests or parameters are applicable to all uses of collagen and users are expected to select and justify a subset of the tests for characterization purposes.  
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4.2.1 Manufacturers of polymerizable collagens and collagen polymeric materials who wish to set specifications for their products or provide characterization data for customers or users. They may also use the terminology and characterization sections to specify and differentiate the properties of polymerizable collagens and collagen polymeric materials.  
4.2.2 Producers of collagen polymeric materials that use polymerizable collagen as starting materials. Producers may use this guide to evaluate and characterize multiple sources of polymerizable collagen. They may also use this guide to assist with evaluation and comparison of single or multiple sources of polymerizable collagen and collagen polymeric materials.  
4.2.3 Researchers may use this guide as a reference for properties and test methods that can be used to reproducibly evaluate polymerizable collagens and collagen polymeric materials.  
4.3 The collagen covered by this guide may be used in a broad range of applications, forms, or medical products, for example (but not limited to) wound an...
SCOPE
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1.2 This guide focuses on characterization of purified polymerizable forms of type I collagen, which is the most abundant collagen in mammalian connective tissues and organs, including skin, bone, tendon, and blood vessels. Polymerizable type I collagen may be derived from a variety of sources including, but not limited to, animal or cadaveric tissues, cell culture, recombinant cell culture, and chemical synthesis.  
1.2.1 This guide covers evaluation of polymerizable collagens and collagen polymeric materials prepared from polymerizable collagens for use as a starting material for wound and hemostatic dressings, surgical implants, substrates for tissue-engineered medical products (TEMPs), delivery vehicles for therapeutic cells or molecules, and 3D in-vitro tissue systems for basic research, diagnostics, drug development, and toxicity testing. Most collagen products on the market today are regulated as devices since their primary intended purpose is not achieved through chemical action within or on the body. However, a medical product comprising polymerizable collagens or collagen polymeric materials may be regulated as a device, biologic, drug, or combination product depending on its intended use and primary mode of action.  
1.2.2 Polymerizable collagen or collagen self-assembly implies that the collagen composition exhibits spontaneous macromolecular assembly from its components without the addition of exogenous factors such as cross-linking agents. Polymerizable collagens may include but are not limited to: (1) tissue-derived monomeric collagens, including tropocollagen or atelocollagen, and oligomeric collagens; (2) collagen proteins and peptides produce...

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4.1 This document describes the basic principles that need to be followed to obtain a mean value of the Darcy permeability coefficient for structures that consist of a series of interconnected voids or pores. The coefficient is a measure of the permeability of the structure to fluid flowing through it that is driven by a pressure gradient created across it.  
4.2 The technique is not sensitive to the presence of closed or blind-end pores (Fig. 1).
FIG. 1 Schematic of the Different Pores Types Found in Tissue Scaffolds. Fluid Flow Through the Structure is via the Open Pores  
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SCOPE
1.1 This guide describes test methods suitable for determining the mean Darcy permeability coefficient for a porous tissue scaffold, which is a measure of the rate at which a fluid, typically air or water, flows through it in response to an applied pressure gradient. This information can be used to optimize the structure of tissue scaffolds, to develop a consistent manufacturing process, and for quality assurance purposes.  
1.2 The method is generally nondestructive and non-contaminating.  
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1.4 Measures of permeability should not be considered as definitive metrics of the structure of porous tissue scaffolds and should complement measures obtained by other investigative techniques, for example, scanning electron microscopy, gas flow porometry, and micro-computer X-ray tomography (Guides F2450, F2603, and F3259).  
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