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Health software and health IT systems safety, effectiveness and security — Part 2-2: Guidance for the implementation, disclosure and communication of security needs, risks and controls

30.60 Close of voting/ comment period

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 — HL7 version 3 — Reference information model — Release 4

90.93 Standard confirmed

ISO/TC 215

Data Exchange Standards — Health Level Seven Version 2.5 — An application protocol for electronic data exchange in healthcare environments

90.93 Standard confirmed

ISO/TC 215

Data Exchange Standards — HL7 Clinical Document Architecture, Release 2

90.93 Standard confirmed

ISO/TC 215

Health informatics — Common terminology services, release 1

90.93 Standard confirmed

ISO/TC 215

Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 1: Framework for adverse event reporting

90.93 Standard confirmed

ISO/TC 215

Health informatics — Individual case safety reports (ICSRs) in pharmacovigilance — Part 2: Human pharmaceutical reporting requirements for ICSR

90.93 Standard confirmed

ISO/TC 215

Health informatics — Personal health device communication — Part 00103: Overview

90.93 Standard confirmed

ISO/TC 215

Health informatics — Device interoperability — Part 10101: Point-of-care medical device communication — Nomenclature

60.60 Standard published

ISO/TC 215

Health informatics — Point-of-care medical device communication — Part 10102: Nomenclature — Annotated ECG

90.93 Standard confirmed

ISO/TC 215

Health informatics — Point-of-care medical device communication — Part 10103: Nomenclature — Implantable device, cardiac

90.93 Standard confirmed

ISO/TC 215