CBA CBA Biomedical Equipment & Technology Assessment

Question 1

Which standard provides the primary framework for managing medical device quality in the US and is enforced by the FDA?

Accepted Answer

21 CFR Part 820

Answer

ISO 9001

Answer

ISO 13485

Answer

IEC 62353

Question 2

A biomedical auditor reviewing preventive maintenance records finds no evidence of scheduled PM for a critical patient monitor for 18 months. The BEST immediate action is to:

Accepted Answer

Issue a major nonconformance and recommend device quarantine

Answer

Document a minor finding and schedule follow-up

Answer

Retrain the biomedical technician

Answer

Update the PM schedule going forward

Question 3

IEC 62353 is the international standard specifically governing:

Accepted Answer

Recurring testing of medical electrical equipment

Answer

Electromagnetic compatibility of medical devices

Answer

Sterilization of healthcare products

Answer

Software lifecycle for medical devices

Question 4

When auditing a hospital's biomedical equipment inventory, which attribute is MOST critical for traceability?

Accepted Answer

Unique device identifier (UDI) and service history

Answer

Device color and location

Answer

Manufacturer's suggested retail price

Answer

Number of staff trained on the device

Question 5

Which of the following BEST describes a 'risk-based' approach to biomedical equipment inspection frequency?

Accepted Answer

Assign inspection intervals based on device criticality, failure risk, and patient impact

Answer

Inspect all devices on the same annual schedule

Answer

Inspect devices only after a reported failure

Answer

Defer to the manufacturer's recommended schedule regardless of clinical use

Question 6

A biomedical auditor discovers that calibration stickers on infusion pumps have expired dates. Which standard is MOST likely cited as nonconformant?

Accepted Answer

21 CFR Part 820.72

Answer

NFPA 99

Answer

ISO 14971

Answer

ANSI/AAMI ES60601-1