Фильтр :
Стандарт и/или проект Этап ТК
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
60.60 ISO/TMBG
Maintenance management program for medical equipment
30.20 ISO/TC 210
Quality systems — Medical devices — Particular requirements for the application of ISO 9001
95.99 ISO/TC 210
Medical devices — Quality management systems — Requirements for regulatory purposes
95.99 ISO/TC 210
Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1
95.99 ISO/TC 210
Medical devices — Quality management systems — Requirements for regulatory purposes
90.93 ISO/TC 210
Quality systems — Medical devices — Particular requirements for the application of ISO 9002
95.99 ISO/TC 210
Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488
95.99 ISO/TC 210
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
95.99 ISO/TC 210
Medical devices — Risk management — Part 1: Application of risk analysis
95.99 ISO/TC 210
Medical devices — Application of risk management to medical devices
95.99 ISO/TC 210
Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
95.99 ISO/TC 210
Medical devices — Application of risk management to medical devices
95.99 ISO/TC 210
Medical devices — Application of risk management to medical devices
60.60 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
95.99 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements — Amendment 1
95.99 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
95.99 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Part 1: General requirements
95.99 ISO/TC 210
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
60.60 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling, and information to be supplied — Part 2: Symbol development, selection and validation
90.92 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
95.99 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
95.99 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 1
95.99 ISO/TC 210
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 2
95.99 ISO/TC 210
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
95.99 ISO/TC 210
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange — Amendment 1
95.99 ISO/TC 210
Medical devices — Quality management — Medical device nomenclature data structure
95.99 ISO/TC 210
Medical devices — Quality management — Medical device nomenclature data structure
95.99 ISO/TC 210
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2000, with reference to Good Manufacturing Practice (GMP)
95.99 ISO/TC 76
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
95.99 ISO/TC 76
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2008, with reference to Good Manufacturing Practice (GMP)
95.99 ISO/TC 76
Primary packaging materials for medicinal products — Particular requirements for the application of ISO 9001:2015, with reference to good manufacturing practice (GMP)
90.20 ISO/TC 76
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
90.60 ISO/TC 210
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
90.20 ISO/TC 210
Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
95.99 ISO/TC 210
Medical devices — Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
95.99 ISO/TC 210
Use and handling of medical devices covered by the scope of ISO/TC 84 — Risk assessment on mucocutaneous blood exposure
95.99 ISO/TC 84
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
95.99 ISO/TC 210
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1
95.99 ISO/TC 210
Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes
95.99 ISO/TC 210
Medical devices — Coding structure for adverse event type and cause
95.99 ISO/TC 210
Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
60.60 ISO/TC 84
Guidance for assessment and evaluation of changes to drug delivery systems
60.60 ISO/TC 84
Global medical device nomenclature for the purpose of regulatory data exchange
95.99 ISO/TC 210
Medical devices — Post-market surveillance for manufacturers
60.60 ISO/TC 210
Medical devices — Information to be supplied by the manufacturer
60.60 ISO/TC 210
Medical devices — Guidance on the application of ISO 14971
95.99 ISO/TC 210
Medical devices — Guidance on the application of ISO 14971
60.60 ISO/TC 210
Medical device software — Software life cycle processes
90.93 ISO/TC 210
Medical device software — Software life cycle processes — Amendment 1
60.60 ISO/TC 210
Medical devices — Part 1: Application of usability engineering to medical devices
90.93 ISO/TC 210
Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
60.60 ISO/TC 210
Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1
60.60 ISO/TC 210
Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
60.60 ISO/TC 210
Medical devices — Application of usability engineering to medical devices
95.99 ISO/TC 210
Medical devices — Application of usability engineering to medical devices — Amendment 1
95.99 ISO/TC 210
Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities
95.99 ISO/TC 215
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
60.60 ISO/TC 215
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
60.60 ISO/TC 215
Application of risk management for IT-networks incorporating medical devices — Part 2-2: Guidance for the communication of medical device security needs, risks and controls
90.92 ISO/TC 215
Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
60.60 ISO/TC 215
Application of risk management for IT-networks incorporating medical devices — Part 2-4: General implementation guidance for Healthcare Delivery Organizations
60.60 ISO/TC 215
Application of risk management for IT-networks incorporating medical devices — Part 2-5: Application guidance — Guidance for distributed alarm systems
60.60 ISO/TC 215
Application of risk management for IT-networks incorporating medical devices — Part 2-8: Application guidance — Guidance on standards for establishing the security capabilities identified in IEC 80001-2-2
90.92 ISO/TC 215
Application of risk management for IT-networks incorporating medical devices — Part 2-9: Application guidance — Guidance for use of security assurance cases to demonstrate confidence in IEC/TR 80001-2-2 security capabilities
60.60 ISO/TC 215
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
60.60 ISO/TC 215
Application of risk management for IT-networks incorporating medical devices — Application guidance — Part 2-7: Guidance for healthcare delivery organizations (HDOs) on how to self-assess their conformance with IEC 80001-1
60.60 ISO/TC 215
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
60.60 ISO/TC 210
Medical device software — Part 2: Validation of software for medical device quality systems
60.60 ISO/TC 210
Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
60.60 ISO/TC 210
Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment
60.60 ISO/TC 299
Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation
60.60 ISO/TC 299
Medical electrical equipment — Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment — Amendment 1
40.99 ISO/TC 299
Medical electrical equipment — Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation — Amendment 1
40.99 ISO/TC 299

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