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Conformité aux normes réglementaires
Standard:
IEC 60601-1:2005
IEC 60601-1/ corr.1:2006
IEC 60601-1/corr.2: 2007
IEC 60601-1/A1:2012
EN 55011
DS/EN 1041:2009
+A1:2013
DS/EN ISO 20417:2021
EN 1640
EN ISO 14971:2019
EN ISO 7494-1
EN ISO 7494-2
EN ISO 1942
DS/EN ISO 9687:2015
+ A1:2018
EN ISO 10993-1
EN ISO 10993-5
EN ISO 10993-10
DS/EN 60601-1-2: 2015
+ A1:2021
EN 62304
EN 62304_2006_A1_2015
EN ISO 15223-1:2021
IEC 60601-1-6:2010
+A1:2015
+A2:2021
IEC 62366
IEC 62366-1
+AC 2016
EN ISO 21530:2004
Title:
Medical electrical equipment
General safety w. corrections
A1
Industrial, scientific and medical equipment – Radio
frequency disturbance characteristic.
Information supplied by the manufacturer of medical
devices
Dentistry – Medical device for dentistry - equipment
Medical device – application of risk management to
medical devices
Dentistry Dental units and Patient Chairs Part 1: General
requirements.
Dentistry Dental units Part 2: Air, Water, Suction and
waste system
Dentistry - Terms
Dentistry Graphical symbols
Biological evaluation of medical devices - Part 1:
Evaluation and testing within a risk management process.
Biological evaluation of medical devices - Part 5: Test for
in vitro cytotoxicity
Biological evaluation of medical devices - Part 10: Tests
for irritation and skin sensitization
Medical electrical equipment-
Part 1-2: EMC
Medical device software – software life-cycle
+ A1
Medical equipment,
Symbols to be used with medical device labels
Medical electrical equipment – Part 1-6: General
Requirements for basic safety and essential performance
– Collateral standard: Usability
Application of usability engineering to medical device
Dentistry – Materials used for dental equipment surfaces
– Determination of resistance to chemical disinfectants
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