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283 publications found under ""

TR 67:2018 [Current]

Connected medical device security

IEC 62304:2006 [Current]

Medical device software — Software life cycle processes

IEC 62304:2006/Amd 1:2015 [Current]

Medical device software — Software life cycle processes — Amendment 1

IEC 63203-801-1:2022 [Current]

Wearable electronic devices and technologies - Part 801-1: Smart body area network (SmartBAN) - Enhanced ultra-low power physical layer

IEC 63203-801-2:2022 [Current]

Wearable electronic devices and technologies - Part 801-2: Smart body area network (SmartBAN) - Low complexity medium access control (MAC) for SmartBAN

IEC 80001-1:2010 [Withdrawn]

Application of risk management for IT-networks incorporating medical devices — Part 1: Roles, responsibilities and activities

IEC 80001-1:2021 [Current]

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

IEC 81001-5-1:2021 [Current]

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

IEC 82304-1:2016 [Current]

Health software — Part 1: General requirements for product safety

IEC TR 80001-2-5:2014 [Current]

Application of risk management for IT-networks incorporating medical devices - Part 2-5: Application guidance - Guidance on distributed alarm systems

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