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Recently Distributed Draft ISO Standard
(ISO/ PDTR 18112) In Vitro Diagnostic Medical Devices for Professional Use
ISO/ PDTR 18112, ISO Technical Report: In Vitro Diagnostic Medical Devices for Professional Use – Summary of Regulatory Requirements for Information Supplied by the Manufacturer
-Second Notice-
ISO/FDIS 15198, Clinical laboratory medicine - In vitro diagnostic medicine devices - Validation of user quality control procedures by the manufacturer
ISO/CD 18112-1, Clinical Laboratory Testing and In Vitro Diagnostic Test Systems – In Vitro diagnostic medical devices – Information supplied by the manufacturer – Part 1: In vitro diagnostic reagents for professional use
To purchase these recently distributed ISO documents, shop NCCLS.
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