Projects and standards

Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

60.60 Standard published

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 Standard published

Medical device software - Part 2: Validation of software for medical device quality systems

60.60 Standard published

Guide to the development and inclusion of aspects of safety in International Standards for medical devices

60.60 Standard published

Guidance on transition periods for standards developed by ISO/TC 84 — Devices for administration of medicinal products and catheters

60.60 Standard published

Medical devices — Post-market surveillance for manufacturers

60.60 Standard published

Medical devices — Guidance on the application of ISO 14971

60.60 Standard published

Application of risk management for IT-networks incorporating medical devices — Part 2-6: Application guidance — Guidance for responsibility agreements

60.60 Standard published

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 Standard published

Medical device software — Part 2: Validation of software for medical device quality systems

60.60 Standard published