Medical products. Evaluation of the biological effect of medical devices. Part 18. Investigation of the chemical properties of materials as part of the risk management process
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In vitro diagnostic medical devices. Measurement of quantities in biological samples. Metrological traceability of values assigned to calibrators and control materials
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Clinical laboratory testing and in vitro medical devices. Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy
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Means of medical and biological provision of a person's vital activity and of viability of biological objects at special units. Terms and definitions
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Kits of reagents for clinical laboratory diagnostics. General specifications
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Kits of reagents for clinical laboratory diagnostics. Test methods
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Medical laboratories. Requirements for safety
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In vitro diagnostics medical devices. Part 1. Automatic analysers for biochemical assays. Technical requirements for public procurement
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In vitro diagnostics medical devices. Part 2. Automatic analyser for immunoassays. Technical requirements for public procurement
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In vitro diagnostics medical devices. Part 3. Automatic analysers for bimolecular assays. Technical requirements for public procurement
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In vitro diagnostics medical devices. Part 4. Automatic analysers for coagulation tests. Technical requirements for public procurement
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In vitro diagnostic medical devices for fluorescent and immunofluorescent analysis of «dried spot» of newborn’s blood. Part 1. Instruments and accessories for fluorescent and immunofluorescent analysis of «dried spot» of newborn’s blood. Technical requirements for state to buy in
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