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    Common aspects of electrical equipment used in medical practice

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    Health software and health IT systems safety, effectiveness and security - Part 2-1: Coordination - Guidance for the use of assurance cases for safety and security
    ISO TS 81001-2-1:2025 forword
    Health software and health IT systems safety, effectiveness and security - Part 2-1: Coordination - Guidance for the use of assurance cases for safety and security

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    • $ 190.87 200.91 | PDF |
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    Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances
    IEC TS 60601-4-6:2024 forword
    Medical electrical equipment - Part 4-6: Guidance and interpretation - Voluntary guidance to help achieve basic safety and essential performance with regard to the possible effects of electromagnetic disturbances

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    • $ 442.12 465.39 | PDF |
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    Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
    IEC TS 60601-4-2:2024 forword
    Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems

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    • $ 345.07 363.23 | PDF |
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    Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices
    IEC 62366-1:2015/COR1:2016 forword
    Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices
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    Corrigendum 1 - Graphical symbols for electrical equipment in medical practice
    IEC TR 60878:2022/COR1:2023 forword
    Corrigendum 1 - Graphical symbols for electrical equipment in medical practice
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    Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005/ISH2:2009 forword
    Interpretation sheet 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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    Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005/AMD1:2012/ISH1:2021 forword
    Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
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    Interpretation sheet 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005/ISH3:2013 forword
    Interpretation sheet 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    • $ 0.00 | PDF |
    Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005/AMD1:2012/COR1:2014 forword
    Corrigendum 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    • $ 0.00 | PDF |
    Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005/COR3:2022 forword
    Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    • $ 0.00 | PDF |
    Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005/COR1:2006 forword
    Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    • $ 0.00 | PDF |
    Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005+AMD1:2012 CSV/COR1:2012 forword
    Corrigendum 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    • $ 0.00 | PDF |
    Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005/ISH1:2008 forword
    Interpretation sheet 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    • $ 0.00 | PDF |
    Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    IEC 60601-1:2005/COR2:2007 forword
    Corrigendum 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
    • $ 0.00 | PDF |
    Medical device software - Part 2: Validation of software for medical device quality systems
    ISO TR 80002-2:2017 forword
    Medical device software - Part 2: Validation of software for medical device quality systems

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    • $ 238.31 250.86 | PDF |
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    Medical devices - Application of risk management to medical devices
    ISO 14971:2019 forword
    Medical devices - Application of risk management to medical devices

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    • $ 190.87 200.91 | PDF |
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    Health informatics -- Guidance on standards for enabling safety in health software
    ISO TR 17791:2013 forword
    Health informatics -- Guidance on standards for enabling safety in health software

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    • $ 190.87 200.91 | PDF |
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    Health software - Part 1: General requirements for product safety
    IEC 82304-1:2016 (EN-FR) forword
    Health software - Part 1: General requirements for product safety

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    • $ 215.67 227.02 | PDF |
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    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
    ISO TR 80001-2-7:2015 forword
    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

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    • $ 238.31 250.86 | PDF |
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    Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements
    ISO TR 80001-2-6:2014 forword
    Application of risk management for IT-networks incorporating medical devices -- Part 2-6: Application guidance -- Guidance for responsibility agreements

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    • $ 105.68 111.24 | PDF |
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    Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
    IEC 81001-5-1:2021 (EN-FR) forword
    Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle

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    • $ 345.07 363.23 | PDF |
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    Health software - Part 2: Health and wellness apps - Quality and reliability
    ISO TS 82304-2:2021 forword
    Health software - Part 2: Health and wellness apps - Quality and reliability

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    • $ 214.59 225.88 | PDF |
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    Guidelines for the development and use of medical electrical equipment educational materials
    IEC TR 61258:2008 forword
    Guidelines for the development and use of medical electrical equipment educational materials

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    • $ 86.27 90.81 | PDF |
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    Amendment 2 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers
    IEC 60601-1-10:2007/AMD2:2020 (EN-FR) forword
    Amendment 2 - Medical electrical equipment - Part 1-10: General requirements for basic safety and essential performance - Collateral Standard: Requirements for the development of physiologic closed-loop controllers

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    • $ 43.13 45.40 | PDF |
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    Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
    IEC 60601-1-11:2015 RLV forword
    Medical electrical equipment - Part 1-11: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment

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    • $ 669.65 704.90 | PDF |
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