| Обозначение | Заглавие на русском языке | Статус | Язык документа | Цена (с НДС 20%)
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 1: Isolated cellular RNA
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Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Part 3: Isolated circulating cell free DNA from plasma
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Medical laboratories - Requirements for collection, transport,receipt, and handling of samples
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Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 1: Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases
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Clinical laboratory testing and in vitro diagnostic test systems - Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices - Part 2: Evaluation of performance of antimicrobial susceptibility test devices
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In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice
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In vitro diagnostic medical devices - Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples
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In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 1: Terminology and general requirements for nucleic acid quality evaluation
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In vitro diagnostic medical devices - Multiplex molecular testing for nucleic acids - Part 2: Validation and verification
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Medical laboratories - Application of risk management to medical laboratories
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Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management
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Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling
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Medical devices utilizing animal tissues and their derivatives - Part 3:Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy(TSE) agents
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Point-of-care testing(POCT) - Requirements for quality and competence
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In vitro diagnostic medical devices - Evaluation of stability of in vitro diagnostic reagents
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Biorisk management for laboratories and other related organisations
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Biological evaluation of medical devices - Part 22: Guidance on nanomaterials
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Biological evaluation of medical devices - Part 33: Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3
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Medical devices utilizing animal tissues and their derivatives - Part 4: Principles for elimination and/or inactivation of transmissible spongiform encephalopathy(TSE) agents and validation assays for those processes
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Medical laboratories - Guidance on laboratory implementation of KS P ISO 15189:2006
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