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DIN EN ISO 9001 rev
Quality management systems - Requirements with guidance for use
prEN ISO 9001 rev
Quality management systems - Requirements with guidance for use
DIN EN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO/FDIS 11137-1:2023); German and English version FprEN ISO 11137-1:2023
prEN ISO 11137-1
Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO/DIS 11137-1:2023)
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 EN 17180
Sterilizers for medical purposes - Low temperature vapourized hydrogen peroxide sterilizers - Requirements and testing; German and English version prEN 17180:2023
FprEN ISO 14630
Non-active surgical implants - General requirements (ISO/FDIS 14630:2024)
prEN ISO 21762
Medical devices utilizing human tissues and their derivatives - Application of risk management
DIN EN ISO 21762
Medical devices utilizing human tissues and their derivatives - Application of risk management
EN 285/FprA1
Sterilization - Steam sterilizers - Large sterilizers