CTF

FLEXTRONICS DESIGN S.R.L.

 
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Standards in Scope

Category
Standard
Tests/Clauses
Acceptance Date
Responsible National Certification Body(s)
MEDIEC 60601-1:2005
5.7 - Humidity Conditioning 5.9.2 - Determination of Accessible Parts 7.1.2 - Legibility of Markings 7.1.3 - Durability of Markings 8.7 - Leakage Current Tests 8.7.4.6 - Touch Leakage Current 8.7.4.7 a) - Patient Leakage Current 8.7.3 e) - Non-Frequency-Weighted Leakage Current 8.8.3 - Dielectric Voltage Withstand 8.8.4.1 - Ball Pressure 11 - Temperature 11.6.5 - Harmful Ingress (Water and Particulates) 11.6.6 - Cleaning and Disinfection 15.3.2 - Enclosure Force 15.3.3 - Enclosure Impact 15.3.4 - Drop Impact 15.3.6 - Mold Stress Relief
2020-01-20
MEDIEC 60601-1:2005/AMD1:2012
5.7 - Humidity Conditioning 5.9.2 - Determination of Accessible Parts 7.1.2 - Legibility of Markings 7.1.3 - Durability of Markings 8.7 - Leakage Current Tests 8.7.4.6 - Touch Leakage Current 8.7.4.7 a) - Patient Leakage Current 8.7.3 e) - Non-Frequency-Weighted Leakage Current 8.8.3 - Dielectric Voltage Withstand 8.8.4.1 - Ball Pressure 11 - Temperature 11.6.5 - Harmful Ingress (Water and Particulates) 11.6.6 - Cleaning and Disinfection 15.3.2 - Enclosure Force 15.3.3 - Enclosure Impact 15.3.4 - Drop Impact 15.3.6 - Mold Stress Relief
2020-01-20
MEDIEC 60601-1-11:2015
4.2.2 - ENVIRONMENTAL CONDITIONS OF TRANSPORT AND STORAGE BETWEEN USES 4.2.3.1 - ENVIRONMENTAL OPERATING CONDITIONS 4.2.3.2 - ENVIRONMENTAL SHOCK TO TRANSIT-OPERABLE ME EQUIPMENT 10.1.2 b) and 10.1.3 c) - BROAD-BAND RANDOM VIBRATION TEST (IEC 60068-2-64:2008) 10.1.2 a) and 10.1.3 a) - SHOCK TEST (IEC 60068-2-27:2008)
2020-01-20
MEDISO 80601-2-56:2017
201.12.1.101 - Additional requirements for accuracy of controls and instruments 201.101.2 - Laboratory accuracy 201.101.3 - Time response for a continuous CLINICAL THERMOMETER
2020-01-20
MEDISO 80601-2-56:2017/AMD1:2018
201.12.1.101 - Additional requirements for accuracy of controls and instruments 201.101.2 - Laboratory accuracy 201.101.3 - Time response for a continuous CLINICAL THERMOMETER
2020-01-20