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BBMRI-ERIC liaisons with international standardization organizations
Since 2015, BBMRI-ERIC has established and actively maintains liaisons to the International Organization for Standardization Technical Committees (ISO/TC).
ISO/TC 276 Biotechnology
Scope: Standardization in the field of biotechnology processes that includes the following topics:
– Terms and definitions;
– biobanks and bioresources;
– analytical methods;
– bioprocessing;
– data processing including annotation, analysis, validation, comparability and integration;
– metrology.
BBMRI-ERIC Delegates: Andrea Wutte, Petr Holub and Rudolf Wittner
ISO/TC 212 Clinical laboratory testing and in vitro diagnostic test systems
Scope: Standardization and guidance in the field of laboratory medicine and in vitro diagnostic test systems. This includes, for example, quality management, pre- and post-analytical procedures, analytical performance, laboratory safety, reference systems and quality assurance.
BBMRI-ERIC Delegates: Andrea Wutte
Technical Committee ISO/TC 215 Health Informatics
Scope: Standardization in the field of health informatics, to facilitate capture, interchange and use of health-related data, information, and knowledge to support and enable all aspects of the health system.
BBMRI-ERIC Delegates: Andrea Wutte and Niina Eklund
Since 2016, BBMRI-ERIC has established and actively maintains a liaison to the European Standardisation Organization (CEN/TC)
CEN/TC 140 In vitro diagnostic medical devices
Scope: 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.
BBMRI-ERIC Delegates: Andrea Wutte
