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Classified Examples of Medical Devices

 
Risk Class III
 

Device Description

Anaesthesia machine
Anaesthesia vaporiser
Apnea monitor
Blood warmer
Bone cement
Brachytherapy device
Cardiac output unit, direct fick
Cardiotocograph
Condom
Contact lens care solution
Diagnostic X-ray equipment
Dialysate delivery system
Dressings for chronic ulcerated wounds
Dressings for severe burns
Electrocautery equipment
Electroconvulsive therapy equipment
External defibrillator
External pacemaker
Heart-lung bypass equipment
Hemodialysis concentrates
Hemodialysis equipment
Hemodialyzer
Hip implant
Hyperbaric chamber
Hyperthermia system
Implantable staple
Infant incubator
Infusion port
Infusion pump
Insulin pen
Intensive care cardiac monitor
Intra-ocular lenses
Linear accelerator
Lithotriptor
Lung ventilator
Maxillo-facial implant
Non-absorbable suture
Pressure regulator for medical gases
Prosthetic joint replacement
RF electrosurgical generator
RF lesion generator
Surgical laser
Therapeutic cyclotron
Therapeutic X-ray equipment
Urethral stent
Warming blanket


Remarks:
1. The above examples of medical devices are for reference only.
2. The actual classification of a particular device must be considered individually, taking account of its design and use intended by the manufacturer.
3. Where a medical device has features that place it into more than one class, conformity assessment should be based on the highest class indicated.
 
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2005 copyright | Important notices

Last revision date: 27 May 2005