Projects

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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

60.60 Standard published

ISO/TC 215

Health software and health IT systems safety, effectiveness and security — Part 5-1: Security — Activities in the product life cycle

60.60 Standard published

ISO/TC 215

Health software — Part 1: General requirements for product safety

90.93 Standard confirmed

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

10.99 New project approved

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

10.99 New project approved

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 Standard published

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 Standard to be revised

ISO/TC 215

Application of risk management for IT-networks incorporating medical devices — Part 2-3: Guidance for wireless networks

60.60 Standard published

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 Standard published

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 Standard published

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 Standard to be revised

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 Standard published

ISO/TC 215

Health informatics — Messages and communication — Web access reference manifest

90.20 Standard under periodical review

ISO/TC 215

Health informatics — Point-of-care medical device communication — Part 90101: Analytical instruments — Point-of-care test

90.93 Standard confirmed

ISO/TC 215

Health informatics — Standard communication protocol — Part 91064: Computer-assisted electrocardiography

90.92 Standard to be revised

ISO/TC 215

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on substances

60.60 Standard published

ISO/TC 215

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of regulated information on pharmaceutical dose forms, units of presentation, routes of administration and packaging

90.92 Standard to be revised

ISO/TC 215

Health informatics — Identification of medicinal products — Data elements and structures for the unique identification and exchange of units of measurement

90.93 Standard confirmed

ISO/TC 215