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
€23.00
IEC 60601-2-31:2020 Medical electrical equipment - Part 2-31: Particular requirements for the basic safety and essential performance of external cardiac pacemakers with internal power source
€389.00
IEC 62366-1:2015/AMD1:2020 Amendment 1 - Medical devices - Part 1: Application of usability engineering to medical devices
€133.00
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
€46.00
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
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
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
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
€12.00
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
€302.00
Medical devices - Application of risk management to medical devices (ISO 14971:2000); German version EN ISO 14971:2000
€111.40
Filter elements - Particle filtration in fluids - Part 1: Characterisation of the particle retention
€41.78
Medical devices - Application of risk management to medical devices (ISO 14971:2007, Corrected version 2007-10-01); English version FprEN ISO 14971:2009, Amendment 1
Quality systems - Medical devices - System requirements for regulatory purposes (ISO/DIS 13485:2002)
€134.02
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9002 (Revision of EN 46002:1996) (Identical to ISO 13488:1996); German version EN ISO 13488:2000.
€77.20
Quality systems - Medical devices - Particular requirements for the application of EN ISO 9001 (Revision of EN 46001:1996) (Identical to ISO 13485:1996); German version EN ISO 13485:2000.
