| Обозначение | Заглавие на русском языке | Статус | Язык документа | Цена (с НДС 20%)
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Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements
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На языке оригинала
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Пишите на gost@gostinfo.ru
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Medical devices - Symbols to be used with medical device labels, labelling, and information to be supplied - Part 2: Symbol development, selection and validation
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Medical devices - Recognized essential principles of safety and performance of medical devices - Part 1: General essential principles and additional specific essential principles for all non-IVD medical devices and guidance on the selection of standards
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Medical devices - Recognized essential principles of safety and performance of medical devices - Part 2: General essential principles and additional specific essential principles for all IVD medical devices and guidance on the selection of standards
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Guidance for assessment and evaluation of changes to drug delivery systems
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Medical devices - Information to be supplied by the manufacturer
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Medical devices - Post-market surveillance for manufacturers
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Medical devices - Guidance on the application of KS P ISO 14971
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Medical device software - Part 2: Validation of software for medical device quality systems
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Application of risk management for IT-networks incorporating medical devices - Part 1: Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software
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Application of risk management for IT-networks incorporating medical devices - Part 2-1: Step by step risk management of medical IT-networks - Practical applications and examples
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Application of risk management for IT-networks incorporating medical devices - Part 2-2: Guidance for the disclosure and communication of medical device security needs, risks and controls
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Application of risk management for IT-networks incorporating medical devices - Part 2-3: Guidance for wireless networks
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На языке оригинала
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Application of risk management for IT-networks incorporating medical devices - Part 2-4: Application guidance - General implementation guidance for healthcare delivery organizations
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