Waste

Question 1

What is a medical device?

Answer 1

Any device intended to be used for medical purposes

Question 2

What are the properties of Class I (Low risk) medical devices?

Answer 2

• CONTROLS REQUIRED: General controls
• EXAMPLES: bandages, wheelchairs

Question 3

What are the properties of Class II (Moderate risk) medical devices?

Answer 3

• CONTROLS REQUIRED: General controls and special controls
• EXAMPLES: catheters, needles, contact lenses

Question 4

What are the properties of Class III (High risk) medical devices?

Answer 4

• CONTROLS REQUIRED: General controls and Premarket approval
• EXAMPLES: pacemakers, coronary stents

Question 5

What is medical waste?

Answer 5

Any substance or object the holder discards, intends to discard or is required to discard