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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: inactive
Page Count: 18
ICS Code (Laboratory medicine): 11.100

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:
EN ISO 13485 - Medical devices - Quality management systems - Requirements for regulatory purposes
Published by CEN 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:
EN ISO 9001 - Quality management systems - Requirements
Published by CEN on September 1, 2015
This International Standard specifies requirements for a quality management system when an organization: a) needs to demonstrate its ability to consistently provide products and services that meet...
This document references:
5725-1 - Accuracy (trueness and precision) of measurement methods and results — Part 1: General principles and definitions
Published by ISO on July 1, 2023
This document — introduces conditions, constraints and resources necessary to evaluate a measurement method or a result; — defines an organizational scheme for the acquisition of trueness and...
This document references:
EN 376 - Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Self-Testing
Published by CEN on February 1, 2002
A description is not available for this item.
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