How-To Guide

P48

Wireless

ET S IEN 300 328 V2.1.1(2016-11)

Safety Conformance

Conforms to the following safety standards

P erform ance

IEC 60601-1:2005+AM D1:2012 CS V M edicalelectricalequipm ent-P art1: Generalrequirementsforbasicsafety

andessentialperform ance

IEC 60601-1-2 2014 M edicalelectricalequipm ent-P art1-2:General requirem entsforbasicsafety and essential

perform ance-C ollateralS tandard: Electrom agneticCapability-R equirem entsandtests

IEC 60601-2-37 2007M edicalelectricalequipm ent-P art2-37:P articular requirem entsforthebasicsafety and

essentialperformanceofultrasonic m edicaldiagnosticandm onitoringequipm ent

IS O 10993-1 2009 Biologicalevaluation ofm edicaldevices-P art1:Evaluation andtestingw ithinariskm anagement

process

AIU M /N EM A U D 2-2004 2009 N EM A S tandardsP ublicationU D 2-2004 (R 2009) AcousticO utputM easurem ent

S tandard forDiagnosticU ltrasound Equipment, R evision3.(R adiology)

AIU M /N EM A U D 3-2004 2009 N EM A S tandardsP ublicationU D 3-2004 (R 2009) S tandard forR eal-T imeDisplay

ofT herm alandM echanicalAcousticO utput IndicesonDiagnosticU ltrasoundEquipm ent

P roductS pecification,DesignR eview,Verification/ValidationandR isk,

IEC 62304 2006 M edicaldevicesoftw are-S oftw arelifecycleprocesses

IEC 62366 2014 M edicaldevices-Application ofusability engineeringtom edicaldevices

IEC 60601-1-6 U sability

IS O 15223-1 2016 M edicaldevices-S ym bolstobeusedw ithmedicaldevicelabels,labelingandinform ationto be

supplied

IS O 13485 2003 M edicalDevices-Q uality M anagem entS ystems-R equirem entsforR egulatoryP urposes

IS O 14971 2007 M edicalDevices-ApplicationofR iskM anagem enttoM edicalDevices

M DD 1993 M edicalDeviceDirective93/42/EEC AN N EX II