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BSI - 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

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Organization: BSI
Publication Date: 28 February 2010
Status: inactive
Page Count: 22
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

21/30416041 DC
August 11, 2021
Draft 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
A description is not available for this item.
BS EN ISO 18113-4
November 30, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 4: In vitro diagnostic reagents for self-testing
A description is not available for this item.
BS EN ISO 18113-4
November 30, 2011
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing
A description is not available for this item.
BS EN ISO 18113-4
February 28, 2010
In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) Part 4: In vitro diagnostic reagents for self-testing
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:
15223-1 - Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
Published by ISO on July 1, 2021
This document specifies symbols used to express information supplied for a medical device. This document is applicable to symbols used in a broad spectrum of medical devices, that are available...
This document references:
GP10-A - Assessment of the Clinical Accuracy of Laboratory Tests Using Receiver Operating Characteristic (ROC) Plots; Approved Guideline
Published by CLSI on December 1, 1995
This guideline outlines the steps and principles for designing a prospective study to evaluate the intrinsic diagnostic accuracy of a clinical laboratory test, i.e., its fundamental ability to...
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:
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 18113-5 - 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 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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