BTC Safety & Regulatory Compliance 3

Question 1

Which ANSI/AAMI standard provides guidance on safe current limits and testing methods for electromedical equipment?

Accepted Answer

ANSI/AAMI ES60601-1

Answer

ANSI/AAMI ES60601-1 is the U.S. adoption of IEC 60601-1 and establishes safety requirements including current limits for electromedical equipment.

Question 2

When performing an electrical safety inspection, a technician measures 120 µA of patient leakage current in a device connected to a patient. What action is required?

Accepted Answer

Tag the device out of service immediately

Answer

Patient leakage current exceeding 100 µA (the NFPA 99 / AAMI limit for patient-connected equipment) requires the device to be removed from service.

Question 3

What is the primary purpose of equipotential grounding in a hospital patient care area?

Accepted Answer

To ensure all conductive surfaces near the patient are at the same electrical potential

Answer

Equipotential grounding connects all conductive surfaces to the same reference potential, eliminating voltage differences that could cause microshock.

Question 4

A hospital biomedical department uses an Alternative Equipment Management (AEM) program. Which criterion is NOT typically required to qualify a device for a non-standard PM interval?

Accepted Answer

Device has not been recalled by the manufacturer in the past 10 years

Answer

AEM eligibility is based on current risk assessment criteria; a past recall does not automatically disqualify a device if current risk criteria are met.

Question 5

Under FDA's Medical Device Reporting (MDR) regulation (21 CFR Part 803), within how many days must a device manufacturer report a death associated with its device?

Accepted Answer

30 calendar days

Answer

Manufacturers must report device-related deaths to the FDA within 30 calendar days of becoming aware of the event.

(BTC) Biomedical Technician Certification Practice Test

(BTC) Biomedical Technician Certification Practice Test

BTC Safety & Regulatory Compliance 3