8/16/25, 10:57
AM
CRCST CHAPTER 5 REGULATIONS AND STANDARDS EXAM
QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS
VERIFIED LATEST UPDATE GRADED A++ 2025/2025
Terms in this set (32)
Statue A written law adopted by a legislative body that
governs a city, county, state or country
Regulation Rules issued by administrative agencies that have the
force of law.
Standard A uniform method of defining basic parameters
for processes, products, services and
measurements.
Regulatory Standards A comparison benchmark that is mandated by
a governing agency. Noncompliance with
regulatory standards may lead to citations
and legal penalties.
Voluntary Standards Guidelines or recommendations for best
practices to provide better patient care.
Industry, nonprofit organizations, trade
associations and others develop these.
Best Practice A method or technique that has consistently
shown results superior to those achieved by
other means.
Occupational Safety and The agency that may intervene in a matter of
1/
5
, 8/16/25, 10:57
AM
Health Administration worker protection even if there are no specific
(OSHA) regulations covering the situation.
Environmental Protection Clean Air Act is administered through this agency. They
Agency (EPA) also impose very strict
labeling requirements on manufacturers of
disinfectants used by the CS department.
minimal levels of quality Healthcare regulations and standards provide:
and safety.
U.S Food and Drug Under current regulations, the device
Administration (FDA) manufactuer and hospitals are required to
report suspected medical device-related
deaths to what organization?
Class I Medical Devices Are low-risk devices such as most hand-held
surgical instruments and ultrasonic cleaners.
Are considered to pose potential risks great
enough to warrant a higher level of regulation.
Class II Medical Devices Most of the sterilization and biologic and
chemical indicators.
Manufacturers are required to submit a
premarket notification application 510(k)
before they can sell these devices.
Are the most stringently regulated devices that
Class III Medical Devices include heart valves, pacemakers, and other
life-sustaining devices. Manufacturers must
obtain a premarket approval (PMA) from the
FDA to demonstrate product safety and
efficacy.
The Safe Medical Act of Requires healthcare facilities to report medical device
1990 malfunctions to the FDA.
2/
5
AM
CRCST CHAPTER 5 REGULATIONS AND STANDARDS EXAM
QUESTIONS AND ANSWERS WITH COMPLETE SOLUTIONS
VERIFIED LATEST UPDATE GRADED A++ 2025/2025
Terms in this set (32)
Statue A written law adopted by a legislative body that
governs a city, county, state or country
Regulation Rules issued by administrative agencies that have the
force of law.
Standard A uniform method of defining basic parameters
for processes, products, services and
measurements.
Regulatory Standards A comparison benchmark that is mandated by
a governing agency. Noncompliance with
regulatory standards may lead to citations
and legal penalties.
Voluntary Standards Guidelines or recommendations for best
practices to provide better patient care.
Industry, nonprofit organizations, trade
associations and others develop these.
Best Practice A method or technique that has consistently
shown results superior to those achieved by
other means.
Occupational Safety and The agency that may intervene in a matter of
1/
5
, 8/16/25, 10:57
AM
Health Administration worker protection even if there are no specific
(OSHA) regulations covering the situation.
Environmental Protection Clean Air Act is administered through this agency. They
Agency (EPA) also impose very strict
labeling requirements on manufacturers of
disinfectants used by the CS department.
minimal levels of quality Healthcare regulations and standards provide:
and safety.
U.S Food and Drug Under current regulations, the device
Administration (FDA) manufactuer and hospitals are required to
report suspected medical device-related
deaths to what organization?
Class I Medical Devices Are low-risk devices such as most hand-held
surgical instruments and ultrasonic cleaners.
Are considered to pose potential risks great
enough to warrant a higher level of regulation.
Class II Medical Devices Most of the sterilization and biologic and
chemical indicators.
Manufacturers are required to submit a
premarket notification application 510(k)
before they can sell these devices.
Are the most stringently regulated devices that
Class III Medical Devices include heart valves, pacemakers, and other
life-sustaining devices. Manufacturers must
obtain a premarket approval (PMA) from the
FDA to demonstrate product safety and
efficacy.
The Safe Medical Act of Requires healthcare facilities to report medical device
1990 malfunctions to the FDA.
2/
5
