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BSI - 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

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Organization: BSI
Publication Date: 30 November 2011
Status: active
Page Count: 22
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

21/30416045 DC
August 11, 2021
Draft 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
A description is not available for this item.
BS EN ISO 18113-5
November 30, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 5: In vitro diagnostic instruments for self-testing
A description is not available for this item.
BS EN ISO 18113-5
November 30, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing
A description is not available for this item.
BS EN ISO 18113-5
February 28, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 5: In vitro diagnostic instruments for self-testing
A description is not available for this item.

References

This document references:
BS ISO 17593 - Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Published by BSI on May 31, 2007
A description is not available for this item.
This document references:
IEC 61010-1 - Safety requirements for electrical equipment for measurement, control, and laboratory use – Part 1: General requirements
Published by IEC on January 1, 2017
Equipment included in scope This group safety publication is primarily intended to be used as a product safety standard for the products mentioned in the scope, but shall also be used by technical...
This document references:
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
Published by IEC on October 1, 2020
In addition to the scope of IEC 61326-1, this part of IEC 61326 specifies minimum requirements for immunity and emissions regarding electromagnetic compatibility for IN VITRO DIAGNOSTIC (IVD) MEDICAL...
This document references:
ISO 15223-1 FRENCH - Dispositifs médicaux - Symboles à utiliser avec les étiquettes, l’étiquetage et les informations à fournir relatifs aux dispositifs médicaux - Partie 1: Exigences générales
Published by ISO on November 1, 2016
A description is not available for this item.
This document references:
BS ISO 17593 - Clinical laboratory testing and in vitro medical devices - Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
Published by BSI on May 31, 2007
A description is not available for this item.
This document references:
BS EN ISO 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by BSI on June 30, 2015
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 18113-4 - 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 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by BSI on June 30, 2015
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 15197 - In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Published by BSI on June 30, 2015
A description is not available for this item.
This document is referenced by:
BS EN ISO 15223-1 CD + PDF - Medical devices. Symbols to be used with medical device labels, labelling and information to be supplied General requirementsts
Published by BSI on January 1, 2021
A description is not available for this item.
This document is referenced by:
BS EN ISO 15223-1 - Medical devices - Symbols to be used with medical device labels, labelling and information to be supplied Part 1: General requirements
Published by BSI on December 31, 2016
A description is not available for this item.
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