CIT Regulatory Compliance & Standards 3

Question 1

When a dental implant is labeled 'sterile,' which sterilization validation standard most commonly applies?

Accepted Answer

All of the above depending on the method used

Answer

The applicable sterilization validation standard depends on the method used — ISO 11135 for ethylene oxide, ISO 11137 for radiation, and ANSI/AAMI ST79 for steam.

Question 2

What is a Corrective and Preventive Action (CAPA) system primarily designed to address in a dental implant facility?

Accepted Answer

Nonconformances and potential quality problems to prevent recurrence

Answer

CAPA systems identify, investigate, and eliminate the root cause of nonconformances and potential quality issues per 21 CFR 820.100.

Question 3

Which regulation requires dental implant manufacturers to submit Medical Device Reports (MDRs) for serious adverse events?

Accepted Answer

21 CFR Part 803

Answer

21 CFR Part 803 (Medical Device Reporting) mandates manufacturers to report device malfunctions and serious injuries or deaths to the FDA.

Question 4

A CIT notices implant packaging has been compromised before use. According to regulatory compliance, what is the correct action?

Accepted Answer

Discard the implant and report through the facility's nonconformance system

Answer

Compromised sterile packaging invalidates the sterility guarantee; the implant must be discarded and the event documented as a nonconformance.

Question 5

What does CE marking on a dental implant indicate in international trade contexts?

Accepted Answer

The device conforms to European Union health, safety, and environmental protection standards

Answer

CE marking indicates conformity with EU Medical Device Regulation (MDR 2017/745), allowing the product to be sold within the European Economic Area.

(CIT) Certified Implantology Technician Practice Test

(CIT) Certified Implantology Technician Practice Test

CIT Regulatory Compliance & Standards 3