Heka Dental Unicline S, Operating And Technical Instructions

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12.3 Regulatory Standards Compliance
Standard: Title:
EN 60601-1:2006
EN 60601-1/ corr.1
EN 60601-1/A1
Medical electrical equipment
Generel safety w. corrections
A1
EN 55011
Industrial, scientific and medical equipment – Radio
frequency disturbance characteristic.
EN 1041:2009
+A1:2013 Information supplied by the manufacturer of medical
devices
EN 1640 Dentistry – Medical device for dentistry - equipment
EN ISO 14971:2012
Medical device – application of risk management to
medical devices
EN 980
Erstattet af
DS/ISO15223-1
Medical equipment,
Symbols to be used with medical device labels
EN ISO 7494-1
Dentistry Dental units Part 1: General requirements
and test methods.
EN ISO 7494-2 Dentistry Dental units Part 2: Air, Water, Suction
and waste system
EN ISO 1942 Dentistry - Terms
EN ISO 9687:2015 Dentistry Graphical symbols
EN ISO 10993-1
Biological evaluation of medical devices - Del 1:
Evaluation and testing within a risk management
process.
EN ISO 10993-5
Biological evaluation of medical devices - Del 5: Test
for in vitro cytotoxicity
EN ISO 10993-10
Biological evaluation of medical devices - Del 10:
Tests for irritation and skin sensitization
EN 60601-1-2: 2015
Medical electrical equipment-
Part 1-2: EMC
EN 62304
EN 62304_2006_A1_2015 Medical device software – software life-cycle
+ A1
EN ISO 15223-1:2016
Medical equipment,
Symbols to be used with medical device labels
IEC 60601-1-6:2010
+A1:2015 Medical electrical equipment – Part 1-6: General
Requirements for basic safety and essential
performance – Collateral standard: Usability
EN 62366-1:2015 Application of usability engineering to medical device
EN ISO 6875:2011
Dentistry
Patient chair
EN ISO 21530:2004
Dentistry – Materials used for dental equipment
surfaces – Determination of resistance to chemical
disinfectants
EN ISO 80601-2-60
Medical electrical equipment – Part 2: Particular
requirements for basic safety and essential
performance of dental equipment