CLSI EP32

Metrological Traceability and Its Implementation, 1st Edition

This document provides guidance to manufacturers for establishing and reporting metrological traceability.

This document is available in electronic format only.

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Chairholder: Marc I. Salit, PhD

Date of Publication: February 17, 2006

Order Code PDF: CLSI EP32RE
ISBN Number: 1-56238-598-4

Order Code Print: print not available

Edition: First

Pages: 56

CLSI EP32 Additional Details

A CLSI-IFCC joint project.

The U.S. Food and Drug Administration (FDA) has evaluated and recognized this approved-level consensus standard for use in satisfying a regulatory requirement.

CLSI EP32 Abstract

Clinical and Laboratory Standards Institute document EP32-R—Metrological Traceability and Its Implementation; A Report provides guidance on establishing traceability of the chemical calibration step in clinical laboratory measurements, based on the traceability requirements for in vitro diagnostic (IVD) medical devices as given in ISO 175111 and ISO 15183,2 and in accordance with the requirements for traceability as stated in the IVD Directive [i.e., Directive of the European Parliament on In Vitro Diagnostic Medical Devices (Directive 98/79/EC)3]. Though this report is aimed principally at manufacturers of IVD medical devices, the concepts and approaches recommended may be extended to apply to routine analysis conducted in the clinical laboratory either with commercially available or “home-brew” IVDs.