11.040.01 : Medical equipment in general

IEC 60601-1-9:2007/AMD2:2020

IEC 60601-1-9:2007/AMD2:2020

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IEC 60601-1-9:2007/AMD2:2020 Amendment 2 - Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

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IEC 80001-1:2021

IEC 80001-1:2021

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IEC 80001-1:2021 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

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IEC 80601-2-26:2019/COR1:2021

IEC 80601-2-26:2019/COR1:2021

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IEC 80601-2-26:2019/COR1:2021 Corrigendum 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

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IEC 81001-5-1:2021

IEC 81001-5-1:2021

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IEC 81001-5-1:2021 Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

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IEC 60601-1:2005/COR3:2022

IEC 60601-1:2005/COR3:2022

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IEC 60601-1:2005/COR3:2022 Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

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IEC 60601-2-75:2017/AMD1:2023

IEC 60601-2-75:2017/AMD1:2023

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IEC 60601-2-75:2017/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-75: Particular requirements for the basic safety and essential performance of photodynamic therapy and photodynamic diagnosis equipment

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IEC 80601-2-77:2019/AMD1:2023

IEC 80601-2-77:2019/AMD1:2023

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IEC 80601-2-77:2019/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-77: Particular requirements for the basic safety and essential performance of robotically assisted surgical equipment

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IEC 60601-2-35:2020/AMD1:2023

IEC 60601-2-35:2020/AMD1:2023

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IEC 60601-2-35:2020/AMD1:2023 Amendment 1 - Medical electrical equipment - Part 2-35: Particular requirements for the basic safety and essential performance of heating devices using blankets, pads or mattresses and intended for heating in medical use

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IEC 80601-2-78:2019/AMD1:2024

IEC 80601-2-78:2019/AMD1:2024

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IEC 80601-2-78:2019/AMD1:2024 Amendment 1 - Medical electrical equipment - Part 2-78: Particular requirements for basic safety and essential performance of medical robots for rehabilitation, assessment, compensation or alleviation

€133.00

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IEC 80601-2-26:2019/AMD1:2024

IEC 80601-2-26:2019/AMD1:2024

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IEC 80601-2-26:2019/AMD1:2024 Amendment 1 - Medical electrical equipment - Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs

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IEEE 2802:2022

IEEE 2802:2022

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IEEE Standard for Performance and Safety Evaluation of Artificial Intelligence Based Medical Devices: Terminology

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ISO/TR 80002-2:2017

ISO/TR 80002-2:2017

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

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ISO/TR 80001-2-6:2014

ISO/TR 80001-2-6:2014

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

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ISO/TR 80001-2-7:2015

ISO/TR 80001-2-7:2015

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Application of risk management for IT-networks incorporating medical devices Application guidance

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NBN - Handbook ISO 13485:2016

NBN - Handbook ISO 13485:2016

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ISO 13485:2016 - Medical devices - A practical guide

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