11.100.10 : In vitro diagnostic test systems

ASTM F3142-16

ASTM F3142-16

Superseded Historical

Standard Guide for Evaluation of in vitro Release of Biomolecules from Biomaterials Scaffolds for TEMPs

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ASTM F2944-20

ASTM F2944-20

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Standard Practice for Automated Colony Forming Unit (CFU) Assays—Image Acquisition and Analysis Method for Enumerating and Characterizing Cells and Colonies in Culture

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BS EN ISO 18113-1:2011

BS EN ISO 18113-1:2011

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In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) Terms, definitions and general requirements

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BS EN ISO 18113-4:2011

BS EN ISO 18113-4:2011

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In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) reagents for self-testing

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BS EN ISO 18113-5:2011

BS EN ISO 18113-5:2011

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In vitro diagnostic medical Devices. Information supplied by the manufacturer (labelling) instruments for self-testing

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BS ISO 21474-1:2020

BS ISO 21474-1:2020

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In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Terminology and general requirements acid quality evaluation

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PD CEN/TS 16826-3:2018

PD CEN/TS 16826-3:2018

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Molecular in vitro diagnostic examinations. Specifications for pre-examination processes snap frozen tissue Isolated DNA

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BS EN IEC 61326-2-6:2021

BS EN IEC 61326-2-6:2021

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Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical

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BS EN ISO 29701:2010

BS EN ISO 29701:2010

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Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test

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BS EN 13641:2002

BS EN 13641:2002

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Elimination or reduction of risk of infection related to in vitro diagnostic reagents

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BS EN 14136:2004

BS EN 14136:2004

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Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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BS EN 13532:2002

BS EN 13532:2002

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General requirements for in vitro diagnostic medical devices for self-testing

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BS EN ISO 13079:2011

BS EN ISO 13079:2011

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Laboratory glass and plastics ware. Tubes for the measurement of the erythrocyte sedimentation rate by the Westergren method

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BS EN 61326-2-6:2013

BS EN 61326-2-6:2013

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Electrical equipment for measurement, control and laboratory use. EMC requirements Particular requirements. In vitro diagnostic (IVD) medical

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BS EN 13975:2003

BS EN 13975:2003

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Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

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