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BSI - BS ISO 17593

Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy

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Organization: BSI
Publication Date: 31 May 2007
Status: active
Page Count: 64
ICS Code (In vitro diagnostic test systems): 11.100.10
ICS Code (Biological evaluation of medical devices): 11.100.20

Document History

BS ISO 17593
March 31, 2022
Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
A description is not available for this item.
BS ISO 17593
May 31, 2007
Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
A description is not available for this item.

References

This document references:
BS EN ISO 18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Published by BSI on November 30, 2011
A description is not available for this item.
This document references:
IEC 61000-4-3 - Electromagnetic compatibility (EMC) – Part 4-3: Testing and measurement techniques – Radiated, radio-frequency electromagnetic field immunity test
Published by IEC on September 1, 2020
This part of IEC 61000 is applicable to the immunity requirements of electrical and electronic equipment to radiated electromagnetic energy. It establishes test levels and the required test...
This document references:
IEC 61010-2-101 - Safety requirements for electrical equipment for measurement, control and laboratory use – Part 2-101: Particular requirements for in vitro diagnostic (IVD) medical equipment
Published by IEC on October 1, 2018
Equipment included in scope This part of IEC 61010 applies to equipment intended for in vitro diagnostic (IVD) medical purposes, including self-test IVD medical purposes. IVD medical equipment,...
This document references:
BS EN ISO 18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) -Part 1: Terms, definitions and general requirements
Published by BSI on October 31, 2011
A description is not available for this item.
This document references:
BS EN ISO 18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
Published by BSI on November 30, 2011
A description is not available for this item.
This document references:
IEC 60068-2-64 - Environmental testing – Part 2-64: Tests – Test Fh: Vibration, broadband random and guidance
Published by IEC on October 1, 2019
This part of IEC 60068 demonstrates the adequacy of specimens to resist dynamic loads without unacceptable degradation of its functional and/or structural integrity when subjected to the specified...
This document references:
BS EN ISO 18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) -Part 1: Terms, definitions and general requirements
Published by BSI on October 31, 2011
A description is not available for this item.
This document references:
BS EN ISO 18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
Published by BSI on November 30, 2011
A description is not available for this item.
This document references:
BS EN ISO 18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Published by BSI on November 30, 2011
A description is not available for this item.
This document references:
BS EN ISO 18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) -Part 1: Terms, definitions and general requirements
Published by BSI on October 31, 2011
A description is not available for this item.
This document references:
BS EN ISO 18113-4 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
Published by BSI on November 30, 2011
A description is not available for this item.
This document references:
BS EN ISO 18113-5 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
Published by BSI on November 30, 2011
A description is not available for this item.
This document is referenced by:
BS EN ISO 14971 + A11 - Medical devices - Application of risk management to medical devices
Published by BSI on December 31, 2019
A description is not available for this item.
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