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11.100.10 In vitro diagnostic test systems
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25/30487902 DC
BS ISO 24884 Electronic Instructions for Use for In Vitro Diagnostic Medical Devices — Minimum required information and means of delivery
BS ISO 24884 Electronic Instructions for Use for In Vitro Diagnostic Medical Devices — Minimum required information and means of delivery
Released: 2025-10-13
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22.40 EUR
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365.12 EUR
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BS ISO 21474-3:2024
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Interpretation and reports
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Interpretation and reports
Released: 2024-11-19
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BS EN ISO 5649:2024
Medical laboratories. Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
Medical laboratories. Concepts and specifications for the design, development, implementation, and use of laboratory-developed tests
Released: 2024-12-13
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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
Use of external quality assessment schemes in the assessment of the performance of in vitro diagnostic examination procedures
Released: 2004-05-26
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159.04 EUR
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BS ISO 15198:2004
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
Clinical laboratory medicine. In vitro diagnostic medical devices. Validation of user quality control procedures by the manufacturer
Released: 2004-07-23
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185.92 EUR
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BS EN ISO 20166-1:2018
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue Isolated RNA
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue Isolated RNA
Released: 2019-02-22
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BS EN ISO 15197:2015
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
In vitro diagnostic test systems. Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus
Released: 2015-06-30
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BS EN 13975:2003
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
Sampling procedures used for acceptance testing of in vitro diagnostic medical devices. Statistical aspects
Released: 2003-03-28
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BS EN ISO 20186-1:2019
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated cellular RNA
Molecular in vitro diagnostic examinations. Specifications for pre-examination processes for venous whole blood Isolated cellular RNA
Released: 2019-04-02
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