CLC/BTTF 88-1 - Automatic operating analytical appliances including In-Vitro-Diagnostic Medical Devices
To prepare a series of publications under IEC/EN 61010-2-08x for automatic and semi-automatic analytical equipment, and in addition - as mandated by the EU Commission - a series of Amendments or a General Amendment for laboratory equipment of series IEC/EN 61010 intended for the use in the medical field (covering the Essential Requirements of the In-Vitro-Diagnostic Medical Device Directive and of the Medical Devices Directive, reduced to the production of one collateral standard, which should list all the relevant essential requirements of the MDD applicable to the series of standards IEC 61010-2-041 through -045, but only if their intended application covers the usage in the medical field). BTTF 88-1 shall develop the above mentioned standards in close co-operation with IEC/TC 66 / SR 66 and particular with Working Group 10, and CLC/TC 62 and other organisations such as CEN TC 140 and EDMA, as both are involved in the IVD medical field or CEN TC 102 and its Working Groups involved in the medical field.
Automatic operating analytical appliances including In-Vitro-Diagnostic Medical Devices
To prepare a series of publications under IEC/EN 61010-2-08x for automatic and semi-automatic analytical equipment, and in addition - as mandated by the EU Commission - a series of Amendments or a General Amendment for laboratory equipment of series IEC/EN 61010 intended for the use in the medical field (covering the Essential Requirements of the In-Vitro-Diagnostic Medical Device Directive and of the Medical Devices Directive, reduced to the production of one collateral standard, which should list all the relevant essential requirements of the MDD applicable to the series of standards IEC 61010-2-041 through -045, but only if their intended application covers the usage in the medical field). BTTF 88-1 shall develop the above mentioned standards in close co-operation with IEC/TC 66 / SR 66 and particular with Working Group 10, and CLC/TC 62 and other organisations such as CEN TC 140 and EDMA, as both are involved in the IVD medical field or CEN TC 102 and its Working Groups involved in the medical field.