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ISO 81001-1:2021

Health software and health IT systems safety, effectiveness and security - Part 1: Principles and concepts

178,01 € 

IEC 60601-1:2021 SER

Medical electrical equipment - ALL PARTS

4.084,00 € 

IEC 60601-1:2005/AMD1:2012/ISH1:2021

Interpretation Sheet 1 - Amendment 1 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

0,00 € 

IEC TR 60601-4-5:2021

Medical electrical equipment - Part 4-5: Guidance and interpretation - Safety-related technical security specifications

280,00 € 

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

700,00 € 

IEC 60601-1-2:2014/AMD1:2020

Amendment 1 - Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests

205,00 € 

IEC 60601-1:2005/AMD2:2020

Amendment 2 - Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

280,00 € 

IEC 60601-1:2005+AMD1:2012+AMD2:2020 CSV (Consolidated Version)

Medical electrical equipment - Part 1: General requirements for basic safety and essential performance

1.100,00 € 

IEC 60601-1-8:2006/AMD2:2020

Amendment 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

280,00 € 

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

900,00 € 

IEC 60601-1-10:2007/AMD2:2020

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

40,00 € 

IEC 60601-1-11:2015/AMD1:2020

Amendment 1 - 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

20,00 € 

IEC 60601-1-12:2014/AMD1:2020

Amendment 1 - 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

20,00 € 

IEC 60601-1-6:2010/AMD2:2020

Amendment 2 - Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

40,00 € 

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

10,00 € 

IEC 60601-1-6:2010+AMD1:2013+AMD2:2020 CSV (Consolidated Version)

Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability

300,00 € 

IEC 60601-1-9:2007+AMD1:2013+AMD2:2020 CSV (Consolidated Version)

Medical electrical equipment - Part 1-9: General requirements for basic safety and essential performance - Collateral Standard: Requirements for environmentally conscious design

255,00 € 

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

350,00 € 

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 € 

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 €