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BSI - BS EN 13612

Performance evaluation of in vitro diagnostic medical devices

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Organization: BSI
Publication Date: 7 May 2002
Status: active
Page Count: 18
ICS Code (In vitro diagnostic test systems): 11.100.10

Document History

BS EN 13612
May 7, 2002
Performance evaluation of in vitro diagnostic medical devices
A description is not available for this item.
BS EN 13612
May 7, 2002
Performance Evaluation of in Vitro Diagnostic Medical Devices
A description is not available for this item.

References

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 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:
EN 12287 - In Vitro Diagnostic Medical Devices - Measurement of Quantities in Samples of Biological Origin - Description of Reference Materials
Published by CEN on June 1, 1999
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 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 13532 - General Requirements for in Vitro Diagnostic Medical Devices for Self-Testing
Published by BSI on May 8, 2002
A description is not available for this item.
This document is referenced by:
BS EN ISO 20776-2 - Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices Part 2: Evaluation of performance of antimicrobial susceptibility test devices against reference broth micro-dilution
Published by BSI on January 31, 2022
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.
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