11.100.10 In vitro diagnostic test systems

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Released: 2020-02-24
BS EN ISO 23640:2015 - TC
Tracked Changes. In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
LANGUAGE
English
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Released: 2015-06-30
BS EN ISO 23640:2015
In vitro diagnostic medical devices. Evaluation of stability of in vitro diagnostic reagents
LANGUAGE
English
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Released: 2010-10-31
BS EN ISO 29701:2010
Nanotechnologies. Endotoxin test on nanomaterial samples for in vitro systems. Limulus amebocyte lysate (LAL) test
LANGUAGE
English
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Released: 2004-07-23
BS ISO 15198:2004
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
LANGUAGE
English
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Released: 2007-05-31
BS ISO 17593:2007
Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
LANGUAGE
English
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Released: 2019-06-06
BS ISO 20916:2019
In vitro diagnostic medical devices. Clinical performance studies using specimens from human subjects. Good study practice
LANGUAGE
English
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Released: 2020-05-27
BS ISO 21151:2020
In vitro diagnostic medical devices. Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
LANGUAGE
English
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Released: 2020-08-24
BS ISO 21474-1:2020
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Terminology and general requirements for nucleic acid quality evaluation
LANGUAGE
English
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Released: 2018-07-23
PD CEN/TS 16826-3:2018
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for snap frozen tissue Isolated DNA
LANGUAGE
English
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Released: 2016-05-31
PD CEN/TS 16945:2016
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for metabolomics in urine, venous blood serum and plasma
LANGUAGE
English
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Released: 2019-04-15
PD CEN/TS 17305:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for saliva. Isolated human DNA
LANGUAGE
English
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Released: 2020-01-24
PD CEN/TS 17390-1:2020
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for circulating tumor cells (CTCs) in venous whole blood Isolated RNA
LANGUAGE
English