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11.100.10 Systémy diagnostických zkoušek in vitro
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BS EN ISO 18113-2:2024
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
In vitro diagnostic medical devices. Information supplied by the manufacturer (labelling) In vitro diagnostic reagents for professional use
Vydáno: 2024-06-12
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PAS 2600:2025
Continuous glucose monitoring systems. Design verification and validation of performance. Specification
Continuous glucose monitoring systems. Design verification and validation of performance. Specification
Vydáno: 2025-11-20
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BS EN ISO 15193:2026
In vitro diagnostic medical devices. Requirements for reference measurement procedures
In vitro diagnostic medical devices. Requirements for reference measurement procedures
Vydáno: 2026-07-22
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26/30488671 DC
BS EN ISO 23640 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
BS EN ISO 23640 In vitro diagnostic medical devices — Evaluation of stability of in vitro diagnostic reagents
Vydáno: 2026-05-06
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BS ISO 21474-2:2022
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Validation and verification
In vitro diagnostic medical devices. Multiplex molecular testing for nucleic acids Validation and verification
Vydáno: 2022-05-17
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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
Vydáno: 2024-12-13
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