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STN EN 13612 (851013)

Performance evaluation of in vitro diagnostic medical devices

Standard published on 1.10.2003

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ČSN EN 13612 (01.11.2002)
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STN EN ISO 23640 (851014)

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

Standard published on 1.11.2015

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ČSN EN ISO 23640 (01.10.2013)
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STN EN 13640 (851014) WITHDRAWN

Stability testing of in vitro diagnostic reagents

WITHDRAWN published on 1.10.2003

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ČSN EN 13640 (01.11.2002)
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STN EN ISO 23640 (851014) WITHDRAWN

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

WITHDRAWN published on 1.5.2012

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ČSN EN ISO 23640 (01.10.2013)
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STN EN ISO 23640 (851014) WITHDRAWN

In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents (ISO 23640:2011)

WITHDRAWN published on 1.6.2013

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ČSN EN ISO 23640 (01.10.2013)
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STN EN 13641 (851015)

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

Standard published on 1.10.2003

We recommend simillar standard:!
ČSN EN 13641 (01.12.2002)
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STN EN ISO 18153 (851016)

In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

Standard published on 1.5.2004

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ČSN EN ISO 18153 (01.06.2004)
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STN EN ISO 18153 (851016) WITHDRAWN

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values for catalytic concentration of enzymes assigned to calibrators and control materials (ISO 18153:2003)

WITHDRAWN published on 1.2.2004

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ČSN EN ISO 18153 (01.06.2004)
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STN EN ISO 17511 (851017)

In vitro diagnostic medical devices - Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples (ISO 17511:2020)

Standard published on 1.9.2021

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ČSN EN ISO 17511 (01.06.2004)
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STN EN ISO 17511 (851017) WITHDRAWN

In vitro diagnostic medical devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials (ISO 17511:2003)

WITHDRAWN published on 1.2.2004

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ČSN EN ISO 17511 (01.06.2004)
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