In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control material (ISO 17511:2003, IDT)
This Malaysian Standard specifies how to assure the metrological traceability of values assigned to calibrators and control materials intended to establish or verify trueness of measurement. The calibrators and control materials are those provided by the manufacturers as part of, or to be used together with, in vitro diagnostic medical devices.
External quality assessment (survey) samples, with proven commutability, whose values have been assigned by means of internationally agreed reference measurement systems or internationally agreed conventional reference measurement systems fall within the scope of this Malaysian Standard.
Published
• (none) / (none) / (none)
PDF
17/01/2021
37
NSC 18 - Medical Devices and Facilities for Healthcare
