Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
Assess and designate Notified Bodies - TOPRA
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Conformity <strong>Assess</strong>ment:<br />
Examples for Risk Classification<br />
• Class I<br />
– wheel chairs, patient beds, non-invasive electrodes<br />
• Class I*<br />
– sterile wound dressings, thermometer<br />
• Class IIa<br />
– ultrasound diagnostic device, respiration tubes, blood<br />
pressure monitoring devices, products for transition of<br />
blood<br />
• Class IIb<br />
– Lithotripthers, ablation devices, ventilators<br />
• Class III<br />
– prosthetic heart valves, neurologic catheters, artificial<br />
joints, breast implants, combination products
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