CEN/TC 140 covers standardization in the field of in vitro diagnostic medical devices, and ISO/TC SC1 handles Genomics Informatics. The newly established liaisons with these two committees will enable the project to benefit from access to the relevant standards which are in development.
Instand-NGS4P plans to submit a new work item proposal to CEN/TC 140 for a new Technical Specification project covering all aspects of the in vitro diagnostic NGS workflow. CEN/TC 140 will benefit from the added-value expertise of the Consortium.
Further Information on the Technical Committees:
CEN/TC 140 In vitro Diagnostic Medical Devices
Standardization in the field of in vitro diagnostic medical devices which are reagents, reagent product, calibrators, control materials, kits, instruments, apparatus, equipment, or system, whether used alone or in combination, intended by the manufacturer to be used in vitro for the examination of specimens, including blood and tissue donations, derived from the human body, solely or principally for the purpose of providing information: – concerning a physiological or pathological state or; – concerning a congenital abnormality or; – to determine the safety and compatibility with potential recipients, or; – to monitor therapeutic measures. Specimen receptacles are considered to be in vitro diagnostic medical devices. ‘Specimen receptacles’ are those devices, whether vacuum-type or not, specifically intended by their manufacturers for the primary containment and preservation of specimens derived from the human body for the purpose of in vitro diagnostic examination. Products for general laboratory use are not in vitro diagnostic medical devices unless such products, in view of their characteristics, are specifically intended by their manufacturer to be used for in vitro diagnostic examination.
ISO/TC 215/SC1 Genomics Informatics
Standardization of computable data, information, and knowledge, including their representation and metadata, for the application of omics, including but not limited to genomics, phenomics and proteomics, to support human health and clinical research. Please note that this website is not officially sanctioned or approved by CEN or ISO
