Обозначение | Заглавие на русском языке | Статус | Язык документа | Цена (с НДС 20%) в рублях |
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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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In vitro diagnostic test systems - Requirements and recommendations for detection of severe acute respiratory syndrome coronavirus 2(SARS-CoV-2) by nucleic acid amplification methods
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Biological evaluation of medical devices - Part 19: Physico-chemical, morphological and topographical characterization of materials
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Clinical laboratory testing в”Ђ Criteria for acceptable lots of dehydrated Mueller-Hinton agar and broth for antimicrobial susceptibility testing
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Medical laboratories в”Ђ Reagents for staining biological material в”Ђ Guidance for users
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