council direct septemb approxim law member state relat electro medic equip human veterinari medicin eec council european commun regard treati establish european econom commun articl thereof regard propos commiss regard opinion european parliament regard opinion econom social committe member state electro medic equip human veterinari medicin meet high defin degre safeti user equip receiv treatment mean equip member state sought ensur degre safeti mandatori specif relat technic safeti regul inspect procedur specif differ member state obstacl establish oper common market reduc elimin specif adopt member state addit place present legisl advis instanc harmon commun level section equip question adequ form harmon refer standard drawn european committe electrotechn standard cenelec order ensur equip compli harmon standard manufactur acknowledg respons mark declar conform technic progress requir prompt adapt technic specif laid direct respect electro medic equip order facilit implement measur requir provis made procedur establish dose cooper member state commiss committe adapt technic progress direct remov technic barrier trade electro medic equip electro medic equip conform requir direct endang public safeti health procedur laid obviat risk adopt direct articl direct appli electro medic equip list annex ii hereinaft call quot equip quot intend natur human veterinari medicin articl member state ground safeti relat manufactur refus prohibit restrict sale free movement intend purpos equip refer articl direct conform requir direct annex technic requir equip conform oj oj oj conform equip requir direct attest manufactur import respons affix mark conform specimen shown annex iii declar conform specimen shown annex iv articl member state ensur servic provid equip meet requir direct reimburs term servic provid equip meet criteria requir provis forc territori author applic minimum requir equip articl adopt accord procedur laid articl amend annex made adapt technic progress harmon standard relev standard organ amend annex desir adapt technic progress relev standard organ made amend harmon standard case amend notifi compet standard organ articl committe adapt technic progress direct remov technic barrier trade electro medic equip hereinaft call quot committe quot set consist repres member state chair commiss repres committe draw rule procedur articl refer made procedur laid articl matter refer committe chairman initi request repres member state commiss repres submit committe draft measur committe give opinion draft time limit set chairman regard urgenc matter opinion deliv major vote vote member state weight provid articl treati chairman vote propos measur accord opinion committe commiss adopt propos measur accord opinion committe opinion deliv commiss delai submit council propos measur council act qualifi major month propos submit council act propos measur adopt commiss articl member state determin basi substanti justif applianc compli requir direct repres hazard safeti provision prohibit sale free movement applianc applianc territori make subject special condit immedi inform member state commiss thereof state ground decis commiss week consult member state concern deliv opinion delai step commiss opinion technic adapt direct adapt adopt commiss council accord procedur laid articl case member state adopt safeguard measur maintain entri forc adapt articl member state measur ensur mark declar conform refer articl issu manufactur import condit laid direct member state make arrang ensur adequ surveil manufactur equip articl member state measur prevent equip mark mark confus eec mark annex iii articl member state bring forc measur compli direct month notif forthwith inform commiss thereof member state commun commiss text provis nation law adopt field govern direct articl direct address member state brussel septemb council presid barri direct notifi member state septemb annex technic requir equip refer articl conform harmon document european committe electrotechn standard cenelec hd gener requir edit document base iec intern electrotechn commiss standard applic subject amend case equip refer annex ii requir hd amend claus equip minim type bf claus patient auxiliari current normal condit ma singl fault condit ma annex ii list equip refer articl diagnost equip exclud equip subject defibril discharg protect equip procur inform live influenc extern sourc equip procur biopotenti equip accessori diagnost monitor purpos studi monitor electr activ electr characterist live be electroencephalograph electrocorticograph electromyograph electroretinograph electronystagmograph equip accessori equip procur paramet equip accessori studi infra red radiat produc live organ diagnost purpos thermoscann thermograph radiat thermomet equip accessori studi acoust activ sensit live be electron stethoscop phonocardioscop phonocardiograph intend cardiovascular intervent audiomet audiophon equip accessori ballistocardiograph electron thermomet intend cardiovascular intervent equip procur inform live influenc extern sourc equip electron sourc equip accessori appli directli electr current live organ equip measur skin resist equip pulmonari vascular imped rheographi equip sourc equip accessori ophthalmolog diagnosi equip illumin ey slit lamp ey mirror spectral light sourc ophthalmoscop equip view imag measur ey ophthalmomet refractomet tonomet photomet retinoscop cornea microscop ophthalmolog diagnost unit consist ophthalmolog equip mention combin auxiliari devic stand column chair equip accessori intend support visibl monocular binocular enlarg diagnost purpos view surgic procedur exclud high frequenc surgic equip surgic microscop colposcop otoscop dermatoscop equip accessori intend local illumin area examin treat head lamp illumin head mirror fluoresc hand lamp mouth lamp therapeut equip specif therapeut equip equip electr energi equip accessori produc electr charg ioniz air vapour mist charg ioniz achiev high voltag electron emiss hot metal equip appli form energi equip accessori produc mechan effect medicin vibrat equip pressur water massag equip extracorpor cardiac massag equip accessori produc hot air steam vapour medic therapeut purpos equip solid liquid materi evapor heat mechan mean inhal purpos hot air bath section includ ultrason equip electro surgic equip equip electr energi equip accessori low frequenc electr energi produc heat electrocauteri equip electrocauteri part combin medic electr equip intend electrocauteri equip form energi equip accessori ophthalmolog therapeut purpos equip treatment ey ey magnet equip accessori equip accessori produc mechan effect medicin drill saw polish equip dentistri surgeri water driven equip equip support replac bodi function exclud implant cardiac stimul implant devic equip support replac mean equip accessori intend support replac bodi function artifici limb aid paralyz artifici speech equip equip accessori intend assist human sensor aid blind equip equip accessori handl posit patient surgic dental purpos oper tabl oper chair oper unit dental chair dental unit annex iii specimen mark conform affix manufactur gt pic file quot quot gt annex iv specimen declar conform applic council direct eec septemb gt pic file quot quot gt