NA 176

DIN Standards Committee Health Technologies

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

Document number Edition Title
DIN EN ISO 9001 2015-11 Quality management systems - Requirements (ISO 9001:2015); German and English version EN ISO 9001:2015 More 
DIN EN ISO/IEC 17011 2018-03 Conformity assessment - Requirements for accreditation bodies accrediting conformity assessment bodies (ISO/IEC 17011:2017); German and English version EN ISO/IEC 17011:2017 More 
DIN EN ISO/IEC 17025 2018-03 General requirements for the competence of testing and calibration laboratories (ISO/IEC 17025:2017); German and English version EN ISO/IEC 17025:2017 More 
EN 1422 2014-05 Sterilizers for medical purposes - Ethylene oxide sterilizers - Requirements and test methods 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 11138-1 2017-03 Sterilization of health care products - Biological indicators - Part 1: General requirements More 
ISO 11138-2 2017-03 Sterilization of health care products - Biological indicators - Part 2: Biological indicators for ethylene oxide sterilization processes More 
ISO 11138-3 2017-03 Sterilization of health care products - Biological indicators - Part 3: Biological indicators for moist heat sterilization processes More 
ISO 11138-4 2017-03 Sterilization of health care products - Biological indicators - Part 4: Biological indicators for dry heat sterilization processes More 
ISO 11138-5 2017-03 Sterilization of health care products - Biological indicators - Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes More