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DIN EN ISO 14155
Clinical investigation of medical devices for human subjects - Good clinical practice (ISO/DIS 14155:2024); German and English version prEN ISO 14155:2024
ISO/CD 11135
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
DIN EN ISO 11135 rev
Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices
DIN SPEC 13285
Standardized method for the determination of the area coverage of ready-to-use for single-use disinfection wipes for use in the medical sector
ISO 10993-23 DAM 1
Biological evaluation of medical devices - Part 23: Tests for irritation - Amendment 1: Additional in vitro reconstructed human epidermis models
prEN ISO 8536-16
Infusion equipment for medical use - Part 16: Infusion sets for single use with volumetric infusion controllers (ISO/DIS 8536-16:2024)
DIN EN 17180
Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
DIN EN 14180
Sterilizers for medical purposes - Low temperature steam and formaldehyde sterilizers - Requirements and testing; German and English version prEN 14180:2023
FprEN ISO 8536-13
Infusion equipment for medical use - Part 13: Graduated flow regulators for single use with fluid contact (ISO/FDIS 8536-13:2024)
IEC 62D/758/CDV
Medical electrical equipment - Part 2-25: Particular requirements for basic safety and essential performance of electrocardiographs
