NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 15378 [Withdrawn] references following documents:

Document number Edition Title
DIN EN 61025 2007-08 Fault tree analysis (FTA) (IEC 61025:2006); German version EN 61025:2007 More 
IEC 60601-1 2005-12 Medical electrical equipment - Part 1: General requirements for basic safety and essential performance More 
IEC 61025 2006-12 Fault tree analysis (FTA) More 
ISO 10012 2003-04 Measurement management systems - Requirements for measurement processes and measuring equipment More 
ISO 11135 2014-07 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-1 2006-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices More 
ISO 11137-2 2013-06 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose More 
ISO 14644-5 2004-08 Cleanrooms and associated controlled environments - Part 5: Operations More 
ISO 14644-7 2004-10 Cleanrooms and associated controlled environments - Part 7: Separative devices (clean air hoods, gloveboxes, isolators and mini-environments) More 
ISO 14937 2009-10 Sterilization of health care products - General requirements for characterization of a sterilizing agent and the development, validation and routine control of a sterilization process for medical devices More