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BSI - BS EN ISO 15197

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

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Organization: BSI
Publication Date: 30 June 2015
Status: active
Page Count: 60
ICS Code (In vitro diagnostic test systems): 11.100.10
ICS Code (Diagnostic equipment): 11.040.55

Document History

BS EN ISO 15197
June 30, 2015
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
A description is not available for this item.
BS EN ISO 15197
June 30, 2013
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
A description is not available for this item.
BS EN ISO 15197
May 27, 2003
In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
A description is not available for this item.
BS EN ISO 15197
May 27, 2003
In vitro diagnostic test systems - Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
A description is not available for this item.
BS EN ISO 15197
May 27, 2003
In vitro diagnostic test systems Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
This International Standard specifies requirements for in vitro glucose monitoring systems that measure glucose concentrations in capillary blood samples and procedures for the verification and the...

References

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 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.
This document references:
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 CEN on October 1, 2011
This part of ISO 18113 specifies requirements for information supplied by the manufacturer of IVD reagents for self-testing. This part of ISO 18113 also applies to information supplied by the...
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 61000-4-2 - Electromagnetic compatibility (EMC) – Part 4-2: Testing and measurement techniques – Electrostatic discharge immunity test
Published by IEC on December 1, 2008
This International Standard relates to the immunity requirements and test methods for electrical and electronic equipment subjected to static electricity discharges, from operators directly, and to...
This document references:
Z316.4-94 - Performance Specifications for Portable Whole Blood Glucose Monitor Systems for Use in Diabetes Management
Published by CSA on March 1, 1994
Scope This Standard specifies requirements for portable whole blood glucose monitor systems, as defined in Clause 3.3 of this Standard, hereinafter referred to as blood glucose monitor system(s),...
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 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.
This document is referenced by:
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.
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