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Quality management system standards our company follow;

ISO 9001:2015 Quality Management System
EN ISO 13485:2016 Quality Management System for Medical Devices

The standard, regulation and guidelines we follow for medical device disinfectants and biocidal products:

Standard No	Standard Name	Published Date
93/42/EEC	Medical Device Directive	07.06.2011
EN 14348:2005	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants. Test methods and requirements (phase 2, step 1).	09.02.2005
EN 14476:2013+A1:2015	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1).	31.12.2013
EN 13727:2012+A2:2015	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of bactericidal activity in the medical area. Test method and requirements (phase 2, step 1).	31.10.2012
EN 13624:2013	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of fungicidal or yeasticidal activity in the medical area. Test method and requirements (phase 2, step 1).	31.10.2013
EN 14561:2006	Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of bactericidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2).	30.06.2006
EN 14562:2006	Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of fungicidal or yeasticidal activity for instruments used in the medical area. Test method and requirements (phase 2, step 2).	30.06.2006
EN 14563:2008	Chemical disinfectants and antiseptics. Quantitative carrier test for the evaluation of mycobactericidal or tuberculocidal activity of chemical disinfectants used for instruments in the medical area. Test method and requirements (phase 2, step 2).	31.12.2008
EN 14348:2005	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of mycobactericidal activity of chemical disinfectants in the medical area including instrument disinfectants. Test methods and requirements (phase 2, step 1).	09.02.2005
EN 14476:2013+A1:2015.	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of virucidal activity in the medical area. Test method and requirements (Phase 2/Step 1).	31.12.2013
MEDDEV 2.7/1 Rev.4	Clinical evaluation: Guide for manufacturers and notified bodies	June 2016
MEDDEV 2.12/1 Rev.8	Medical devices vigilance system	Jan 2013
MEDDEV 2.12/2 Rev.2	Post Market Clinical Follow-up studies	Jan 2012
ASTM F1980-16	Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices	15.09.2016
EN 1040:2005	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of basic bactericidal activity of chemical disinfectants and antiseptics. Test method and requirements (phase 1).	16.01.2006
EN 1275:2005	Chemical disinfectants and antiseptics. Quantitative suspension test for the evaluation of basic fungicidal or basic yeasticidal activity of chemical disinfectants and antiseptics. Test method and requirements (phase 1).	16.01.2006
EN 1500:2013	Chemical disinfectants and antiseptics. Hygienic handrub. Test method and requirements (phase 2/step 2).	31.05.2013
EN 12791:2016+A1:2017	Chemical disinfectants and antiseptics. Surgical hand disinfection. Test method and requirements (phase 2, step 2).	29.02.2016