NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 14160 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 13408-5 2011-09 Aseptic processing of health care products - Part 5: Sterilization in place (ISO 13408-5:2006); German version EN ISO 13408-5:2011 More 
DIN EN ISO 13408-6 2021-11 Aseptic processing of health care products - Part 6: Isolator systems (ISO 13408-6:2021); German version EN ISO 13408-6:2021 More 
DIN EN ISO 13408-7 2015-11 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products (ISO 13408-7:2012); German version EN ISO 13408-7:2015 More 
DIN EN ISO 14937 2010-03 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 (ISO 14937:2009); German version EN ISO 14937:2009 More 
DIN EN ISO 17665-1 2006-11 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (ISO 17665-1:2006); German version EN ISO 17665-1:2006 More 
DIN EN ISO 18362 2018-11 Manufacture of cell-based health care products - Control of microbial risks during processing (ISO 18362:2016); German and English version prEN ISO 18362:2018 More 
DIN EN ISO 22442-1 2021-08 Medical devices utilizing animal tissues and their derivatives - Part 1: Application of risk management (ISO 22442-1:2020); German version EN ISO 22442-1:2020 More 
DIN EN ISO 22442-2 2021-04 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (ISO 22442-2:2020); German version EN ISO 22442-2:2020 More 
DIN EN ISO 22442-3 2008-03 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy (TSE) agents (ISO 22442-3:2007); German version EN ISO 22442-3:2007 More 
DIN EN ISO 9004 2018-08 Quality management - Quality of an organization - Guidance to achieve sustained success (ISO 9004:2018); German and English version EN ISO 9004:2018 More