This specification covers the design and dimensional requirements for reusable glass Westergren tubes that measure the erythrocyte sedimentation rate (ESR), which is the suspension stability, or amount of settling after a specified time, of red blood cells in diluted, anti-coagulated human blood. The tubes shall be fabricated from Type I, Class B borosilicate glass, or Type II soda lime glass. Tubes shall comply with requirements for graduation line length and numbering, marking permanency, grinding bevel, and workmanship. The tubes should also pass a pigmentation and amber stain test.
Область применения1.1 This specification describes requirements for a tube that measures the erythrocyte sedimentation rate (ESR). ESR is the suspension stability of red cells in diluted, anti-coagulated human blood.
1.1.1 The use of the term “rate” is, strictly speaking, not correct. The test measures the amount of settling of red cells after a specified time.
1.2 The tubes are used together with a special rack to ensure they remain in a vertical position during the test.
1.3 This specification includes many dimensional requirements that are, for the most part, in agreement with the British Standards Institution, German Standards Institute, International Committee for Standardization in Haematology, and the National Committee for Clinical Laboratory Standards publications on Westergren tubes. The clinical procedure using the tube described in this specification is known as the “Westergren Method.”
1.4 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard.
1.5 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.
1.6 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.