• Hydrogen Technologies Standards form the basic framework for market ramp-up

    More information
  • Climate change Standards and specifications support climate targets

    More information
  • Smart Farming Standards and specifications are drivers for the digitalization of agriculture

    More information

Publications of ISO/TC 215/JWG 7

DIN CEN ISO/TS 82304-2 2022-04 Technical Specification Health software - Part 2: Health and wellness apps - Quality and reliability (ISO/TS 82304-2:2021); German version CEN ISO/TS 82304-2:2021 More  Order from DIN Media
DIN EN 82304-1 ; VDE 0750-102-1:2018-04 2018-04 Standards Health Software - Part 1: General requirements for product safety (IEC 82304-1:2016); German version EN 82304-1:2017 More  Order from DIN Media
DIN IEC/TR 80001-2-5 ; VDE 0756-2-5:2016-03 2016-03 Technical Report Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems (IEC/TR 80001-2-5:2014) More  Order from DIN Media
IEC/TR 80001-2-8 2016-05 Technical rule 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 More  Order from DIN Media
IEC 80001-1 2021-09 Standards Safety, effectiveness and security in the implementation and use of connected medical devices or connected health software - Part 1: Application of risk management More  Order from DIN Media
IEC 81001-5-1 2021-12 Standards Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle More  Order from DIN Media
IEC 82304-1 2016-10 Standards Health software - Part 1: General requirements for product safety More  Order from DIN Media
ISO/TR 80001-2-6 2014-12 Technical rule Application of risk management for IT-networks incorporating medical devices - Part 2-6: Application guidance - Guidance for responsibility agreements More  Order from DIN Media
ISO/TR 80001-2-7 2015-04 Technical rule 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 More  Order from DIN Media
ISO/TS 82304-2 2021-07 Pre-standard Health software - Part 2: Health and wellness apps - Quality and reliability More  Order from DIN Media

TOP