NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 11139 [CURRENT] references following documents:

Document number Edition Title
ISO 17664-2 2021-02 Processing of health care products - Information to be provided by the medical device manufacturer for the processing of medical devices - Part 2: Non-critical medical devices More 
ISO 17665 2024-03 Sterilization of health care products - Moist heat - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 18362 2016-02 Manufacture of cell-based health care products - Control of microbial risks during processing More 
ISO 18472 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment More 
ISO 20417 2021-04 Medical devices - Information to be supplied by the manufacturer More 
ISO 20857 2010-08 Sterilization of health care products - Dry heat - Requirements for the development, validation and routine control of a sterilization process for medical devices More 
ISO 25424 2018-10 Sterilization of health care products - Low temperature steam and formaldehyde - Requirements for development, validation and routine control of a sterilization process for medical devices More 
ISO 9000 2015-09 Quality management systems - Fundamentals and vocabulary More 
ISO/ASTM 52303 2015-07 Guide for absorbed-dose mapping in radiation processing facilities More 
ISO/IEC Guide 51 2014-04 Safety aspects - Guidelines for their inclusion in standards More