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Standard and/or project | Stage | TC |
---|---|---|
Guide to the development and inclusion of aspects of safety in International Standards for medical devices
|
90.20 | ISO/TMBG |
Cleanliness of medical devices — Process design and test methods
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30.98 | ISO/TC 194 |
Medical supply units
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40.60 | ISO/TC 121/SC 6 |
Quality systems — Medical devices — Particular requirements for the application of ISO 9001
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95.99 | ISO/TC 210 |
Medical devices — Quality management systems — Requirements for regulatory purposes
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95.99 | ISO/TC 210 |
Medical devices — Quality management systems — Requirements for regulatory purposes — Technical Corrigendum 1
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95.99 | ISO/TC 210 |
Medical devices — Quality management systems — Requirements for regulatory purposes
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90.93 | ISO/TC 210 |
Quality systems — Medical devices — Particular requirements for the application of ISO 9002
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95.99 | ISO/TC 210 |
Quality systems — Medical devices — Guidance on the application of ISO 13485 and ISO 13488
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95.99 | ISO/TC 210 |
Medical devices — Quality management systems — Guidance on the application of ISO 13485: 2003
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95.99 | ISO/TC 210 |
Medical devices — Risk management — Part 1: Application of risk analysis
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95.99 | ISO/TC 210 |
Medical devices — Application of risk management to medical devices
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95.99 | ISO/TC 210 |
Medical devices — Application of risk management to medical devices — Amendment 1: Rationale for requirements
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95.99 | ISO/TC 210 |
Medical devices — Application of risk management to medical devices
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95.99 | ISO/TC 210 |
Medical devices — Application of risk management to medical devices
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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
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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
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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
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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
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95.99 | ISO/TC 210 |
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements
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60.60 | ISO/TC 210 |
Medical devices — Symbols to be used with information to be supplied by the manufacturer — Part 1: General requirements — Amendment 1: Addition of defined term for authorized representative and Modified EC REP symbol to not be country or region specific
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40.60 | 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
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90.92 | ISO/TC 210 |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
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95.99 | ISO/TC 210 |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied
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95.99 | ISO/TC 210 |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 1
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95.99 | ISO/TC 210 |
Medical devices — Symbols to be used with medical device labels, labelling and information to be supplied — Amendment 2
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95.99 | ISO/TC 210 |
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
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95.99 | ISO/TC 210 |
Nomenclature — Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange — Amendment 1
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95.99 | ISO/TC 210 |
Medical devices — Quality management — Medical device nomenclature data structure
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95.99 | ISO/TC 210 |
Medical devices — Quality management — Medical device nomenclature data structure
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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)
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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)
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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)
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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)
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90.93 | 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) — Amendment 1: Climate action changes
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60.60 | 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
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95.99 | 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
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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
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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
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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
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95.99 | ISO/TC 84 |
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes
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95.99 | ISO/TC 210 |
Medical devices — Hierarchical coding structure for adverse events — Part 1: Event-type codes — Amendment 1
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95.99 | ISO/TC 210 |
Medical devices — Hierarchical coding structure for adverse events — Part 2: Evaluation codes
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95.99 | ISO/TC 210 |
Medical devices — Coding structure for adverse event type and cause
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95.99 | ISO/TC 210 |
Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters
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60.60 | ISO/TC 84 |
Guidance for assessment and evaluation of changes to drug delivery systems
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90.20 | ISO/TC 84 |
Global medical device nomenclature for the purpose of regulatory data exchange
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95.99 | ISO/TC 210 |
Medical devices — Post-market surveillance for manufacturers
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60.60 | ISO/TC 210 |
Medical devices — Information to be supplied by the manufacturer
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90.92 | ISO/TC 210 |
Medical devices — Information to be supplied by the manufacturer
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40.00 | ISO/TC 210 |
Medical devices — Guidance on the application of ISO 14971
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95.99 | ISO/TC 210 |
Medical devices — Guidance on the application of ISO 14971
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60.60 | ISO/TC 210 |
Medical device software — Software life cycle processes
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90.93 | ISO/TC 210 |
Medical device software — Software life cycle processes — Amendment 1
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60.60 | ISO/TC 210 |
Medical devices — Part 1: Application of usability engineering to medical devices
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90.93 | ISO/TC 210 |
Medical devices — Part 1: Application of usability engineering to medical devices — Amendment 1
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60.60 | ISO/TC 210 |
Medical devices — Part 1: Application of usability engineering to medical devices — Technical Corrigendum 1
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60.60 | ISO/TC 210 |
Medical devices — Part 2: Guidance on the application of usability engineering to medical devices
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90.92 | ISO/TC 210 |
Medical devices — Application of usability engineering to medical devices
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95.99 | ISO/TC 210 |
Medical devices — Application of usability engineering to medical devices — Amendment 1
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95.99 | ISO/TC 210 |
Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities
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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
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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
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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
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90.92 | ISO/TC 215 |
Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks
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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
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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
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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
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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
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60.60 | ISO/TC 215 |
Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements
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90.60 | 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
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90.60 | ISO/TC 215 |
Medical device software — Part 1: Guidance on the application of ISO 14971 to medical device software
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60.60 | ISO/TC 210 |
Medical device software — Part 2: Validation of software for medical device quality systems
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60.60 | ISO/TC 210 |
Medical device software — Part 3: Process reference model of medical device software life cycle processes (IEC 62304)
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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
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90.92 | 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
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90.92 | 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
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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 — Amendment 1
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60.60 | ISO/TC 299 |
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