STERILE PROCESSING 2026 EXAMINERS SET
QUESTIONS AND ANSWERS SURE A+
✔✔What is the classification of medical devices? What is the risk? Does it require a
510k or pre-market approval? Please explain and give an example of each. - ✔✔1.
Class I Medical devices-low risk, no pre-market approval. Ex:Ultrasonic cleaners
2. Class II Medical devices- medium risk, needs 510k.
Ex: Sterilizers
3. Class III Medical devices-high risk, requires pre-market approval.
Ex: Heart valves
✔✔What is a 510k application vs Pre-market approval ? - ✔✔-510k application is used
when there are changes in the product.
-Pre-market approval is done when there is a new product being released.
✔✔Due to the Safe Medical Devices Act of 1990, healthcare facilities are required to
report events to the FDA and manufacturer within ___ working days. - ✔✔10
✔✔What are the categories for FDA recalls ? What is their risk? What can it cause? -
✔✔Class I-High risk, causes serious health/death
Class II-medium risk, causes temporary health problems
Class III-low risk, low chance of causing health issues
✔✔What is the Umbrella? Please illustrate. - ✔✔(U.N.S.A.F.E.J.O.E)
, ✔✔CDC - ✔✔Centers for Disease Control. Federal agency that issues infection control
guidelines.
✔✔EPA - ✔✔Environmental Protection Agency. Establishes in 1970 to enforce federal
laws pertaining to air and water pollution and other environmentally related statues.
✔✔DOT - ✔✔Department of Transportation. Federal agency that regulates labeling and
containment of hazardous waste, biohazard items and minimally processed items for
transport.
✔✔OSHA - ✔✔Occupational Safety and Health Administration. Primary role is to protect
workers from conditionally caused illnesses and injuries.
✔✔AAMI - ✔✔Association for the Advancement of Medical Instrumentation. Develops
recommended practices and standards.
✔✔ANSI - ✔✔American National Standards Institute. Standards are submitted to ANSI
for approval, such as AAMI.
✔✔AORN - ✔✔Association of Operating Room Nurses. Dedicated to providing optimal
care to the surgical patient.
✔✔APIC - ✔✔Association for professionals in Infection Control and Epidemiology.
Voluntary international organization dedicated to the prevention and control of infections
and related outcomes.
✔✔ISO - ✔✔International Standards Organization. Globally based non-governmental
standards organization.
✔✔Joint Commission - ✔✔Independent non-profit organization, sets healthcare quality
standards and protects patients and visitors, conducts inspections of healthcare
facilities.
✔✔NFPA - ✔✔National Fire Protection Association. International association that works
to reduce the burden of fire and other hazards; sets fire safety standards.
✔✔USP-NF - ✔✔United States Pharmacopeia-National Formulary. Sets standards for
packaging, labeling, bacteriological purity, pH, and mineral content.
✔✔WHO - ✔✔World Health Organization. Combats infectious diseases and promotes
the general health of the people of the world.
QUESTIONS AND ANSWERS SURE A+
✔✔What is the classification of medical devices? What is the risk? Does it require a
510k or pre-market approval? Please explain and give an example of each. - ✔✔1.
Class I Medical devices-low risk, no pre-market approval. Ex:Ultrasonic cleaners
2. Class II Medical devices- medium risk, needs 510k.
Ex: Sterilizers
3. Class III Medical devices-high risk, requires pre-market approval.
Ex: Heart valves
✔✔What is a 510k application vs Pre-market approval ? - ✔✔-510k application is used
when there are changes in the product.
-Pre-market approval is done when there is a new product being released.
✔✔Due to the Safe Medical Devices Act of 1990, healthcare facilities are required to
report events to the FDA and manufacturer within ___ working days. - ✔✔10
✔✔What are the categories for FDA recalls ? What is their risk? What can it cause? -
✔✔Class I-High risk, causes serious health/death
Class II-medium risk, causes temporary health problems
Class III-low risk, low chance of causing health issues
✔✔What is the Umbrella? Please illustrate. - ✔✔(U.N.S.A.F.E.J.O.E)
, ✔✔CDC - ✔✔Centers for Disease Control. Federal agency that issues infection control
guidelines.
✔✔EPA - ✔✔Environmental Protection Agency. Establishes in 1970 to enforce federal
laws pertaining to air and water pollution and other environmentally related statues.
✔✔DOT - ✔✔Department of Transportation. Federal agency that regulates labeling and
containment of hazardous waste, biohazard items and minimally processed items for
transport.
✔✔OSHA - ✔✔Occupational Safety and Health Administration. Primary role is to protect
workers from conditionally caused illnesses and injuries.
✔✔AAMI - ✔✔Association for the Advancement of Medical Instrumentation. Develops
recommended practices and standards.
✔✔ANSI - ✔✔American National Standards Institute. Standards are submitted to ANSI
for approval, such as AAMI.
✔✔AORN - ✔✔Association of Operating Room Nurses. Dedicated to providing optimal
care to the surgical patient.
✔✔APIC - ✔✔Association for professionals in Infection Control and Epidemiology.
Voluntary international organization dedicated to the prevention and control of infections
and related outcomes.
✔✔ISO - ✔✔International Standards Organization. Globally based non-governmental
standards organization.
✔✔Joint Commission - ✔✔Independent non-profit organization, sets healthcare quality
standards and protects patients and visitors, conducts inspections of healthcare
facilities.
✔✔NFPA - ✔✔National Fire Protection Association. International association that works
to reduce the burden of fire and other hazards; sets fire safety standards.
✔✔USP-NF - ✔✔United States Pharmacopeia-National Formulary. Sets standards for
packaging, labeling, bacteriological purity, pH, and mineral content.
✔✔WHO - ✔✔World Health Organization. Combats infectious diseases and promotes
the general health of the people of the world.
