KYAMBOGO UNIVERSITY

FACULTY OF ENGINEERING
ELECTRICAL DEPARTMENT
BACHELOR OF MECHATRONICS AND BIOMEDICAL
ENGINEERING
COURSE WORK 1
NAME REGISTRATION NUMBER
NYERO STEPHEN 20/U/BIO/7658/PD
ALOBO OLING TIMOTHY 20/U/BIO/7678/PD
AYUGI MARY KEVINAH 20/U/BIO/7666/PD

ELECTRICAL SAFETY TESTING OF MEDICAL EQUIPMENT

Safety testing ensures the safety of clinicians, visitors or patients who may come in contact with any
electrical devices. It is always part of the preventive maintenance procedures and designed or
developed to prevent danger to anyone through electric shock. The international standard, IEC 60601-1,
states the safety requirements for manufacturers of medical devices but this standard has also been
adapted for routine testing medical devices.

WHY PERFORM ELECTRICAL SAFETY TESTS?

This ensures medical equipment is electrically safe for use in healthcare environment by testing for
breakdown and damage.

MEDICAL EQUIPMENT CLASSES;

Class 1:
These are low risk medical devices, i.e. these devices present minimal potential for harm to the user.
47% of devices fall under this category. Examples; handheld instruments, syringe, gloves, sun glasses

Class 2:
These are medium risk medical devices. 43% of medical equipment fall under this category. Require
special labeling requirements, mandatory performance standards and post market research.

Wheel chair, x-ray machines, dental implants, catheters.

Class 3:
High risk devices that support or sustain human life. Examples include pacemakers, breast implants.

Heat valves.

SAFETY STANDARDS AND QUALITY ASSURANCE.

Safety standards
This establishes a framework by which hospitals, doctors and other health care
providers may voluntarily report information to the right patient safety organization e.g.
blood borne pathogens, viral blood disease transfers.

Quality assurance prevents flaws in the way a medical device is manufactured. This happens
throughout the production the medical device manufacturing process.

Quality assurance responsibilities can be summarized in these primary steps:

 Plan by setting quality objectives and determining how they will meet them.
 Do by implementing new processes or changing older processes.
 Study by monitoring these processes and modifying them if they aren’t meeting the predefined
objectives.
 Act by implementing any of the improvements they found necessary.

EQUIPMENTS USED FOR PERFORMING EST

 Electrical safety analyzers
 Patient monitor testers
 Incubator/ radiant warmer analyzers
 Infusion device analyzers
 Electrical surgical unit testers
 Ventilator analyzers
 Pressure/ flow meters
 multimeters