NA 176

DIN Standards Committee Health Technologies

DIN EN 14683 [CURRENT] references following documents:

Document number Edition Title
EN ISO 10993-7/A1 2022-01 Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals - Amendment 1: Applicability of allowable limits for neonates and infants (ISO 10993-7:2008/Amd 1:2019) More 
EN ISO 10993-9 2021-09 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products (ISO 10993-9:2019) More 
EN ISO 13485 2016-03 Medical devices - Quality management systems - Requirements for regulatory purposes (ISO 13485:2016) More 
EN ISO 139 2005-01 Textiles - Standard atmospheres for conditioning and testing (ISO 139:2005) More 
EN ISO 15223-1 2021-09 Medical devices - Symbols to be used with information to be supplied by the manufacturer - Part 1: General requirements (ISO 15223-1:2021) More 
EN ISO 16972 2020-03 Respiratory protective devices - Vocabulary and graphical symbols (ISO 16972:2020) More 
EN ISO 22610 2006-07 Surgical drapes, gowns and clean air suits, used as medical devices, for patients, clinical staff and equipment - Test method to determine the resistance to wet bacterial penetration (ISO 22610:2006) More 
EN 14065 2016-05 Textiles - Laundry processed textiles - Biocontamination control system More 
EN 149+A1 2009-05 Respiratory protective devices - Filtering half masks to protect against particles - Requirements, testing, marking More 
EUV 2017/745 2017-04-05 Regulation (EU) 2017/745 of the European Parliament and of the Council of 5 April 2017 on medical devices, amending Directive 2001/83/EC, Regulation (EC) No 178/2002 and Regulation (EC) No 1223/2009 and repealing Council Directives 90/385/EEC and 93/42/EEC More