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Division Whole system failure rateF1

United Kingdom

Original text. Later amendments are not shown.

The whole system failure rate means the frequency of failures when the entire process is performed as prescribed by the manufacturer.

Annotations

Textual amendments

F1

Substituted by Commission Decision of 27 November 2009 amending Decision 2002/364/EC on common technical specifications for in vitro diagnostic medical devices (notified under document C(2009) 9464) (Text with EEA relevance) (2009/886/EC).