ISO TS 81001-2-1:2025Health software and health IT systems safety, effectiveness and security - Part 2-1: Coordination - Guidance for the use of assurance cases for safety and security
177,00 €
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IEC TS 60601-4-6:2024Medical 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
410,00 €
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IEC TS 60601-4-2:2024Medical electrical equipment - Part 4-2: Guidance and interpretation - Electromagnetic immunity: performance of medical electrical equipment and medical electrical systems
320,00 €
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IEC TR 60878:2022/COR1:2023Corrigendum 1 - Graphical symbols for electrical equipment in medical practice
0,00 €
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IEC 60601-1:2005/COR3:2022Corrigendum 3 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
0,00 €
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IEC 81001-5-1:2021Health software and health IT systems safety, effectiveness and security - Part 5-1: Security - Activities in the product life cycle
320,00 €
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IEC 80001-1:2021Application 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
249,99 €
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ISO TS 82304-2:2021Health software - Part 2: Health and wellness apps - Quality and reliability
199,00 €
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ISO 81001-1:2021Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts
199,00 €
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IEC 60601-1:2005/AMD1:2012/ISH1:2021Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
0,00 €
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IEC TR 60601-4-5:2021Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications
320,00 €
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IEC 60601-1-2:2014+AMD1:2020 CSV (Consolidated Version)Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
1.110,00 €
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IEC 60601-1-2:2014/AMD1:2020Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests
249,99 €
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IEC 60601-1:2005/AMD2:2020Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
320,00 €
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IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV (Consolidated Version)Medical electrical equipment - Part 1: General requirements for basic safety and essential performance
1.960,00 €
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IEC 60601-1-8:2006/AMD2:2020Amendment 2 - Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
320,00 €
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IEC 60601-1-8:2006+AMD1:2012+AMD2:2020 CSV (Consolidated Version)Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems
1.530,00 €
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IEC 60601-1-10:2007/AMD2:2020Amendment 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
40,00 €
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