CLSI ISO 15198:2004
Clinical laboratory medicine — In vitro diagnostic medical devices — Validation of user quality control procedures by the manufacturer
ISO 15198:2004 describes a process for manufacturers of in vitro diagnostic medical devices to validate quality control procedures they recommend to their users. These quality control procedures are intended to provide users with assurance that device performance is consistent with its intended use and the manufacturers' claims. ISO 15198:2004 applies to all in vitro diagnostic medical devices.
This document is available in electronic only.
Details
Date of Publication: July 1, 2004
Order Code PDF: CLSI ISO15198E
Order Code Print: print not available
Edition: First
Pages: 10
CLSI ISO 15198:2004 Additional Details
Membership discounts cannot be applied to ISO documents because they are not published by CLSI. CLSI is able to offer ISO Technical Committee 212 approved and draft standards through an agreement with the American National Standards Institute.
Technical Committee: ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems.