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1
Regulation
Declaration of Conformity(Europe only)
(FarmScan® M30,FarmScan® M50,FarmScan® L60 ,FarmScan® L70)
BMV Technology Co., Ltd
declare that this product is in compliance with the essential requirements of Directives
93/42/EEC As amended by 2007/47/EC:
ENISO14971:2009
ISO10993-1:2009
EC60601-2-37:2008EN1041:1998
EN980:2008
EN62304:2006
EN60601-1:1988+A1:1991+A2:1995
IEC60601-1-2: 2007I
EN60601-1-4:1996+A1:1999
The declaration of Conformity(DoC) is on our website.
Execution Standard(Safety)
Standard Number
Standard Name
EN60601-1
Medical Electronic Device, Part I:General safety requirements
IEC60601-1-2:2007
Medical Electronic Device, Part I to II: General Safety Requirement --
Parallel Standard: Requirement and Testing of Electromagnetism
Compatibility
IEC60601-1-4:2000
Medical Electronic Device, Section I to IV: A Program-controlled
Medical Electronic System
IEC60601-2-37
Medical Electronic Device, Specialized Safety Requirements for
Medical Ultrasound Diagnosis and Custodial Care Facility
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