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In vitro diagnostic test systems

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BS EN 1658:1997

Requirements for marking of in vitro diagnostic instruments

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BS EN 12376:1999

In vitro diagnostic medical devices. Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology

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BS EN 13640:2002

Stability testing of in vitro diagnostic reagents

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BS EN 13641:2002

Elimination or reduction of risk of infection related to in vitro diagnostic reagents

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BS EN 14136:2004

Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures

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BS EN 13532:2002

General requirements for in vitro diagnostic medical devices for self-testing

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BS EN 13975:2003

Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects

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BS EN ISO 17511:2003

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and ...

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BS EN ISO 18153:2003

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration ...

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BS EN 13612:2002

Performance evaluation of in vitro diagnostic medical devices

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ISO/TR18112 : 2006 EDTN1

ISO18112 : 2006 Clinical laboratory testing and in vitro diagnostic test systems - In vitro diagnostic medical devices for professional use - Summary ...

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BS EN ISO 15197:2003

In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus

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