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BSI - BS ISO 15198

Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer

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Organization: BSI
Publication Date: 26 July 2004
Status: active
Page Count: 18
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

BS ISO 15198
July 26, 2004
Clinical laboratory medicine In vitro diagnostic medical devices Validation of user quality control procedures by the manufacturer
A description is not available for this item.

References

This document references:
ISO 10005 - Quality management - Guidelines for quality plans
Published by ISO on June 1, 2018
This document gives guidelines for establishing, reviewing, accepting, applying and revising quality plans. This document is applicable to quality plans for any intended output, whether a process,...
This document references:
BS ISO 10005 - Quality management — Guidelines for quality plans
Published by BSI on June 30, 2018
A description is not available for this item.
This document references:
BS EN ISO 15194 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
Published by BSI on May 31, 2009
A description is not available for this item.
This document references:
BS ISO 5725-1 - Accuracy (trueness and precision) of measurement methods and results Part 1: General principles and definitions
Published by BSI on July 31, 2023
A description is not available for this item.
This document references:
BS EN ISO 9000 - Quality management systems - Fundamentals and vocabulary
Published by BSI on September 30, 2015
A description is not available for this item.
This document references:
BS EN ISO 15194 - In vitro diagnostic medical devices - Measurement of quantities in samples of biological origin - Requirements for certified reference materials and the content of supporting documentation
Published by BSI on May 31, 2009
A description is not available for this item.
This document is referenced by:
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 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.
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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