NA 027

DIN Standards Committee Optics and Precision Mechanics

DIN EN ISO 5840-1 [CURRENT] references following documents:

Document number Edition Title
DIN EN ISO 11137-1 2020-04 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (ISO 11137-1:2006, including Amd.1:2013 + Amd.2:2018); German version EN ISO 11137-1:2015 + A2:2019 More 
DIN EN ISO 11137-3 2017-11 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control (ISO 11137-3:2017); German version EN ISO 11137-3:2017 More 
DIN EN ISO 14630 2013-03 Non-active surgical implants - General requirements (ISO 14630:2012); German version EN ISO 14630:2012 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 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 25539-1 2018-05 Cardiovascular implants - Endovascular devices - Part 1: Endovascular prostheses (ISO 25539-1:2017); German version EN ISO 25539-1:2017 More 
DIN EN ISO 5840-2 2021-05 Cardiovascular implants - Cardiac valve prostheses - Part 2: Surgically implanted heart valve substitutes (ISO 5840-2:2021); German version EN ISO 5840-2:2021 More 
DIN EN ISO 5840-3 2021-05 Cardiovascular implants - Cardiac valve prostheses - Part 3: Heart valve substitutes implanted by transcatheter techniques (ISO 5840-3:2021); German version EN ISO 5840-3:2021 More