NA 176

DIN Standards Committee Health Technologies

DIN EN ISO 14160 [CURRENT] references following documents:

Document number Edition Title
ISO 10993-1 2018-08 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process 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 13408-2 2018-01 Aseptic processing of health care products - Part 2: Sterilizing filtration More 
ISO 13408-3 2006-09 Aseptic processing of health care products - Part 3: Lyophilization More 
ISO 13408-4 2005-11 Aseptic processing of health care products - Part 4: Clean-in-place technologies More 
ISO 13408-5 2006-11 Aseptic processing of health care products - Part 5: Sterilization in place More 
ISO 13408-6 2021-04 Aseptic processing of health care products - Part 6: Isolator systems More 
ISO 13408-7 2012-08 Aseptic processing of health care products - Part 7: Alternative processes for medical devices and combination products More 
DIN EN ISO 10012 2004-03 Measurement management systems - Requirements for measurement processes and measuring equipment (ISO 10012:2003); Trilingual version EN ISO 10012:2003 More 
DIN EN ISO 10993-1 2021-05 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (ISO 10993-1:2018, including corrected version 2018-10); German version EN ISO 10993-1:2020 More