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BSI - BS EN ISO 15197 - TC

Tracked Changes (Redline) - In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus

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Organization: BSI
Publication Date: 25 February 2020
Status: active
Page Count: 131
ICS Code (In vitro diagnostic test systems): 11.100.10
ICS Code (Diagnostic equipment): 11.040.55

Document History

BS EN ISO 15197 - TC
February 25, 2020
Tracked Changes (Redline) - In vitro diagnostic test systems - Requirements for bloodglucose monitoring systems for self-testing in managing diabetes mellitus
A description is not available for this item.

References

This document references:
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
Published by ISO on December 1, 2019
This document — amplifies the general principles for designing experiments for the numerical estimation of the precision of measurement methods by means of a collaborative interlaboratory experiment;...
This document references:
18113-5 - In vitro diagnostic medical devices — Information supplied by the manufacturer (labelling) — Part 5: In vitro diagnostic instruments for self-testing
Published by ISO on October 1, 2022
This document specifies requirements for information supplied by the manufacturer of in vitro diagnostic (IVD) instruments intended for self-testing. This document is also applicable to apparatus and...
This document references:
ISO 18113-1 - In vitro diagnostic medical devices - Information supplied by the manufacturer (labelling) - Part 1: Terms, definitions and general requirements
Published by ISO on December 15, 2009
This part of ISO 18113 defines concepts, establishes general principles and specifies essential requirements for information supplied by the manufacturer of IVD medical devices. This part of ISO...
This document references:
ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by ISO on March 1, 2016
This International Standard specifies requirements for a quality management system where an organization needs to demonstrate its ability to provide medical devices and related services that...
This document references:
ISO 14971 - Medical devices - Application of risk management to medical devices
Published by ISO on December 1, 2019
This document specifies terminology, principles and a process for risk management of medical devices, including software as a medical device and in vitro diagnostic medical devices. The process...
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