International Classification

Question 1

If you were classifying a Non-Invasive Medical device using the international Rules, which group of rules would you reference?
A) Rules 1-4
B) Rules 5-8
C) Rules 9-12
D) Rules 13-17

Answer 1

Answer: A) Rules 1-4

Rules 1-4 are setup to classify Non-invasive devices
Rules 5-8 are setup to classify Invasive devices
Rules 9-12 are setup to classify Active Devices
Rules 13-17 are setup to classify any additional devices that don’t fall into the above categories

Question 2

If you are classifying an active device that is intended for diagnosis using ionizing radiation, which rule would you follow?
A) Rule 9
B) Rule 10
C) Rule 11
D) Rule 12

Answer 2

Answer: Rule 10

Rule 9 covers therapeutic and therapeutic monitoring devices.
Rule 10 cover all active devices intended for diagnosis
Rule 11 covers active devices intended to administer or remove medicinal products/bodily fluids/substances
Rule 12 catches all other active medical devices

Question 3

If you were to classify a tube used for blood transfusion, which rule would you follow?
A) Rule 1
B) Rule 2
C) Rule 3 
D) Rule 4

Answer 3

Answer: Rule 2

Rule 1 covers non-invasive devices that come in contact with injured skin
Rule 2 covers non-invasive devices that store or channel liquid or gas
Rule 3 covers non-invasive devices intended to modify the biological or chemical composition of blood or other liquids for infusion
Rule 4 covers all other non-invasive devices

Question 4

What rule would you reference if you were trying to classify dentures to be removed by the patient?
A) Rule 5
B) Rule 6
C) Rule 7
D) Rule 8

Answer 4

Answer: Rule 5

Rule 5  all invasive devices not connected to an active device or connected to class A device ONLY
Rule 6 all surgically invasive devices intended for transient use
Rule 7 all surgically invasive devices intended for short term use
Rule 8 all long term surgically invasive device or implants

Question 5

What rule would use you use to classify a heart valve?
A) Rule 13
B) Rule 14
C) Rule 15
D) Rule 16
E) Rule 17

Answer 5

Answer: Rule 14

Rule 13 devices incorporating medicine
Rule 14 devices manufactured with human or animal cells/tissue
Rule 15 devices to be used to sterilize other devices
Rule 16 devices intended for disinfecting or cleaning
Rule 17 devices for contraception or transmission of STD’s