IEC 60601-1-10:2007+AMD1:2013+AMD2:2020 CSV (Consolidated Version)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
370,00 €
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IEC 60601-1-11:2015+AMD1:2020 CSV (Consolidated Version)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
450,00 €
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IEC 60601-1-12:2014+AMD1:2020 CSV (Consolidated Version)Medical electrical equipment - Part 1-12: General requirements for basic safety and essential performance - Collateral Standard: Requirements for medical electrical equipment and medical electrical systems intended for use in the emergency medical services environment
400,00 €
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IEC 62366-1:2015+AMD1:2020 CSV (Consolidated Version)Medical devices - Part 1: Application of usability engineering to medical devices
500,00 €
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IEC 62366-1:2015/AMD1:2020Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices
110,00 €
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IEC TR 60601-4-3:2018Medical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
365,00 €
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IEC TR 60601-4-3:2018 RLVMedical electrical equipment - Part 4-3: Guidance and interpretation - Considerations of unaddressed safety aspects in the third edition of IEC 60601-1 and proposals for new requirements
475,01 €
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IEC TR 60601-4-4:2017Medical electrical equipment - Part 4-4: Guidance and interpretation - Guidance for writers of particular standards when creating alarm system-related requirements
145,00 €
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ISO TR 80002-2:2017Medical device software - Part 2: Validation of software for medical device quality systems
198,00 €
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IEC TR 60601-4-1:2017Medical electrical equipment - Part 4-1: Guidance and interpretation - Medical electrical equipment and medical electrical systems employing a degree of autonomy
320,00 €
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IEC TR 80001-2-9:2017Application of risk management for IT-networks incorporating medical devices - Part 2-9: Application guidance - Guidance for use of security assurance cases to demonstrate confidence in IEC TR 80001-2-2 security capabilities
215,00 €
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IEC 62366-1:2015/COR1:2016Corrigendum 1 - Medical devices - Part 1: Application of usability engineering to medical devices
0,00 €
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IEC TR 80001-2-8:2016Application 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 TR 80001-2-2
285,01 €
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IEC TR 60601-4-2:2016Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
285,01 €
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IEC TR 62366-2:2016Medical devices - Part 2: Guidance on the application of usability engineering to medical devices
345,00 €
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IEC 62304:2006/AMD1:2015Amendment 1 - Medical device software - Software life cycle processes
255,00 €
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