11.100.30 - Analysis of blood and urine

This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also i...view more

This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for genomic DNA analysis examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by (e.g., medical laboratorie...view more

This International Standard specifies requirements for in vitro glucose monitoring systems that measure
glucose concentrations in capillary blood samples, for specific design verification procedures and for
the validation of performance by the intended users. These systems are intended for self-measurement
by lay persons for management of diabetes mellitus.
This International Standard is applicable to manufacturers of such systems and those other organizations
(e.g. regulatory authorities a...view more