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 |