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Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard - Fifth Edition, H02A5 红细胞沉降率试验程序;认可标准-第五版 H02A5
发布日期: 2011-05-01
临床和实验室标准协会文件H02-A5-血沉率试验程序; 批准标准第五版是2000年12月发布的第四版批准标准(H02-A4)的修订版。 该文件概述了在稀释(1:4)血液上执行标准化(Westergren)方法的必要细节 用于测定血沉率(ESR)的样本。质量保证和其他方法的评估 还描述了测量ESR的方法,包括制备供临床使用的新鲜血液标准物质的程序 ESR设备的实验室或制造。本标准为验证、验证、质量保证、, 以及ESR测量设备的质量控制或相关控制。 目标受众包括此类产品的制造商 设备、最终用户临床实验室、认证机构和监管机构。
Clinical and Laboratory Standards Institute document H02-A5-Procedures for the Erythrocyte Sedimentation Rate Test; Approved Standard-Fifth Edition is a revision of the fourth edition approved standard (H02-A4) published in December 2000. The document outlines the necessary details for the performance of a standardized (Westergren) method on diluted (1:4) blood specimens for the determination of the erythrocyte sedimentation rate (ESR). Quality assurance and evaluation of other methods to measure the ESR are also described, including procedures for the preparation of a fresh blood reference material for use in the laboratory or manufacturing of ESR devices. This standard provides guidance for the validation, verification, quality assurance, and quality control of ESR measurement devices or related controls. The intended audience includes manufacturers of such devices, end-user clinical laboratories, accrediting organizations, and regulatory bodies.
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