CEN/TC 140 - In vitro diagnostic systems
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.
Diagnostični sistemi in vitro
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.
General Information
Frequently Asked Questions
CEN/TC 140 is a Technical Committee within the European Committee for Standardization (CEN). It is named "In vitro diagnostic systems" and is responsible for: 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. This committee has published 123 standards.
CEN/TC 140 develops CEN standards in the area of S21 - LABORATORY MEDICINE, CLINICAL PATHOLOGY AND BIOSAFETY. The scope of work includes: 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. Currently, there are 123 published standards from this technical committee.
The European Committee for Standardization (CEN) is a public standards organization that brings together the national standardization bodies of 34 European countries. CEN provides a platform for developing European Standards (ENs) and other technical documents in relation to various products, materials, services, and processes, supporting the European Single Market.
A Technical Committee (TC) in CEN is a group of experts responsible for developing international standards in a specific technical area. TCs are composed of national member body delegates and work through consensus to create standards that meet global industry needs. Each TC may have subcommittees (SCs) and working groups (WGs) for specialized topics.