BS EN ISO 15197:2015 PDF

Standard No.: BS EN ISO 15197:2015
Release Date: 2015
Published By: British Standards Institution (BSI)
Latest: BS EN ISO 15197:2015
Replace: BS EN ISO 15197:2013

BS EN ISO 15197:2015 Referenced Document

98/79/EC Directive of the European Parliament and of the Council on in Vitro Diagnostic Medical Devices
EN 13612 Performance evaluation of in vitro diagnostic medical devices
EN 13612:2002 Performance evaluation of in vitro diagnostic medical devices
EN 60068-2-64:2008 Environmental testing - Part 2-64: Tests - Test Fh: Vibration, broadband random and guidance
EN 61010-1:2010 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements*， 2023-12-23 Update
EN 61010-2-101:2002 Safety requirements for electrical equipment for measurement, control, and laboratory use Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment*， 2023-12-23 Update
EN 61326-1:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements
EN 61326-2-6:2013 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment
EN 62366:2008 Medical devices - Application of usability engineering to medical devices
EN ISO 13485:2012 Medical devices - Quality management systems - Requirements for regulatory purposes - Technical Corrigendum 1 (Incorporating corrigendum July 2012)
EN ISO 14971:2012 Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01)
EN ISO 17511:2003 In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials ISO 17511:2003
EN ISO 18113-1:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms@ definitions and general requirements
EN ISO 18113-4:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing (ISO 18113-4:2009)*， 2023-12-23 Update
EN ISO 18113-5:2011 In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing (ISO 18113-5:2009)*， 2023-12-23 Update
IEC 61010-1 Safety requirements for electrical equipment for measurement, control, and laboratory use - Part 1: General requirements*， 2017-01-01 Update
IEC 61326-1 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 1: General requirements*， 2020-10-26 Update
IEC 61326-2-6 Electrical equipment for measurement, control and laboratory use - EMC requirements - Part 2-6: Particular requirements - In vitro diagnostic (IVD) medical equipment*， 2020-10-28 Update
IEC 62366 Medical devices - Application of usability engineering to medical devices
ISO 13485 Medical devices - Quality management systems - Requirements for regulatory purposes*， 2016-03-01 Update
ISO 14971 Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements*， 2019-12-10 Update
ISO 17511 In vitro diagnostic medical devices — Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples*， 2020-04-24 Update
ISO 18113-1 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 1: Terms, definitions, and general requirements*， 2022-10-06 Update
ISO 18113-4 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 4: In vitro diagnostic reagents for self-testing*， 2022-10-06 Update
ISO 18113-5 In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing*， 2022-10-06 Update
ISO 23640 In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
ISO 5725-1 Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions*， 2023-07-01 Update
ISO 5725-2 Accuracy (trueness and precision) of measurement methods and results — Part 2: Basic method for the determination of repeatability and reproducibility of a standard measurement method*， 2019-12-06 Update
ISO 5725-3 Accuracy (trueness and precision) of measurement methods and results — Part 3: Intermediate precision and alternative designs for collaborative studies*， 2023-06-01 Update
ISO/IEC Guide 99:2007 International vocabulary of metrology - Basic and general concepts and associated terms (VIM)

BS EN ISO 15197:2015 history

2015 BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
2013 BS EN ISO 15197:2013 In vitro diagnostic test systems. Requirements for blood-glucosemonitoring systems for self-testing in managing diabetes mellitus
2003 BS EN ISO 15197:2003 In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

BS EN ISO 15197:2015 In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

BS EN ISO 15197:2015 Referenced Document

BS EN ISO 15197:2015 history

BS EN ISO 15197:2015
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus