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Medical electrical equipment - Part 2-84: Particular requirements for the basic safety and essential performance of ventilators for the emergency medical services environment
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Medical electrical equipment - Part 2-90: Particular requirements for basic safety and essential performance of respiratory high-flow therapy equipment
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Anaesthetic and respiratory equipment - Heat and moisture exchangers(HMEs) for humidifying respired gases in humans - Part 2:HMEs for use with tracheostomized patients having minimum tidal volumes of 250 mL
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Implants for surgery - Essential principles of safety and performance
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Non-active surgical implants - Implant coating - Part 2: Reference standards related to coatings
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Evaluation of CPB devices relative to their capabilities of reducing the transmission of gaseous microemboli(GME) to a patient during cardiopulmonary bypass
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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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Cardiovascular biological evaluation of medical devices - Guidance for absorbable implants
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Medical device software - Part 2: Validation of software for medical device quality systems
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General requirements of tissue-engineered medical products
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Cardiovascular implants and artificial organs - Checklists for use of extracorporeal circulation equipment
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Biological evaluation of absorbable medical devices - Part 1: General requirements
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Needle-based injection systems for medical use - Requirements and test methods - Part 2: Double-ended pen needles
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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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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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