CBA CBA Biomedical Equipment & Technology Assessment 3

Question 1

Electrical safety testing of medical equipment in the US most commonly references which standard to determine leakage current limits?

Accepted Answer

ANSI/AAMI ES60601-1

Answer

ANSI/AAMI ES60601-1 is the US-adopted version of IEC 60601-1, specifying safety requirements and leakage current limits for medical electrical equipment.

Question 2

A biomedical auditor finds that a hospital performs no electromagnetic compatibility (EMC) assessments when placing new wireless devices near existing medical equipment. This is a nonconformance because:

Accepted Answer

EMC assessments are required to prevent device interference that could compromise patient safety

Answer

EMC assessments are essential to ensure wireless devices do not interfere with nearby medical equipment, a requirement addressed in IEC 60601-1-2 and FDA guidance.

Question 3

When auditing end-of-life (EOL) medical device management, the auditor's MAIN concern should be:

Accepted Answer

Whether EOL devices are identified, segregated, and disposed of per regulatory and environmental requirements

Answer

EOL management must ensure that retired medical devices are properly identified, removed from service, and disposed of in compliance with regulatory and environmental regulations.

Question 4

Which metric is MOST useful for a biomedical auditor evaluating the effectiveness of a preventive maintenance program?

Accepted Answer

PM completion rate (percentage of scheduled PMs completed on time)

Answer

PM completion rate directly measures whether scheduled maintenance is being executed as planned, making it the primary KPI for PM program effectiveness.

Question 5

A hospital biomedical department outsources service on complex imaging equipment to an OEM. During an audit, which document is MOST critical to review?

Accepted Answer

The service contract, qualification records, and access to service reports

Answer

When service is outsourced, auditors must verify that service contracts define scope, that service providers are qualified, and that service records are accessible to the hospital.

(CBA) Certified Biomedical Auditor Practice Test

(CBA) Certified Biomedical Auditor Practice Test

CBA CBA Biomedical Equipment & Technology Assessment 3