NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 11138-7 [CURRENT] references following documents:

Document number Edition Title
ISO 11138-7 2019-03 Sterilization of health care products - Biological indicators - Part 7: Guidance for the selection, use and interpretation of results More 
ISO 11139 2018-08 Sterilization of health care products - Vocabulary of terms used in sterilization and related equipment and process standards More 
ISO 11737-1 2018-01 Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products More 
ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes 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 
ISO 18472 2018-08 Sterilization of health care products - Biological and chemical indicators - Test equipment More 
ISO 19011 2018-07 Guidelines for auditing management systems 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 9001 2015-09 Quality management systems - Requirements More 
ISO/IEC Guide 2 2004-11 Standardization and related activities - General vocabulary More