CRCST Chapter 5 Regulations and Standards || WELL-
ENLIGHTENED QUESTIONS & ANSWERS!!
Statue correct answers A written law adopted by a legislative body that governs a city,
county, state or country
Regulation correct answers Rules issued by administrative agencies that have the force of
law.
Standard correct answers A uniform method of defining basic parameters for processes,
products, services and measurements.
Regulatory Standards correct answers A comparison benchmark that is mandated by a
governing agency. Noncompliance with regulatory standards may lead to citations and legal
penalties.
Voluntary Standards correct answers Guidelines or recommendations for best practices to
provide better patient care. Industry, nonprofit organizations, trade associations and others
develop these.
Best Practice correct answers A method or technique that has consistently shown results
superior to those achieved by other means.
Occupational Safety and Health Administration (OSHA) correct answers The agency that
may intervene in a matter of worker protection even if there are no specific regulations
covering the situation.
Environmental Protection Agency (EPA) correct answers Clean Air Act is administered
through this agency. They also impose very strict labeling requirements on manufacturers of
disinfectants used by the CS department.
minimal levels of quality and safety. correct answers Healthcare regulations and standards
provide:
U.S Food and Drug Administration (FDA) correct answers Under current regulations, the
device manufactuer and hospitals are required to report suspected medical device-related
deaths to what organization?
Class I Medical Devices correct answers Are low-risk devices such as most hand-held
surgical instruments and ultrasonic cleaners.
Class II Medical Devices correct answers Are considered to pose potential risks great enough
to warrant a higher level of regulation. 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.
Class III Medical Devices correct answers Are the most stringently regulated devices that
include heart valves, pacemakers, and other life-sustaining devices. Manufacturers must
ENLIGHTENED QUESTIONS & ANSWERS!!
Statue correct answers A written law adopted by a legislative body that governs a city,
county, state or country
Regulation correct answers Rules issued by administrative agencies that have the force of
law.
Standard correct answers A uniform method of defining basic parameters for processes,
products, services and measurements.
Regulatory Standards correct answers A comparison benchmark that is mandated by a
governing agency. Noncompliance with regulatory standards may lead to citations and legal
penalties.
Voluntary Standards correct answers Guidelines or recommendations for best practices to
provide better patient care. Industry, nonprofit organizations, trade associations and others
develop these.
Best Practice correct answers A method or technique that has consistently shown results
superior to those achieved by other means.
Occupational Safety and Health Administration (OSHA) correct answers The agency that
may intervene in a matter of worker protection even if there are no specific regulations
covering the situation.
Environmental Protection Agency (EPA) correct answers Clean Air Act is administered
through this agency. They also impose very strict labeling requirements on manufacturers of
disinfectants used by the CS department.
minimal levels of quality and safety. correct answers Healthcare regulations and standards
provide:
U.S Food and Drug Administration (FDA) correct answers Under current regulations, the
device manufactuer and hospitals are required to report suspected medical device-related
deaths to what organization?
Class I Medical Devices correct answers Are low-risk devices such as most hand-held
surgical instruments and ultrasonic cleaners.
Class II Medical Devices correct answers Are considered to pose potential risks great enough
to warrant a higher level of regulation. 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.
Class III Medical Devices correct answers Are the most stringently regulated devices that
include heart valves, pacemakers, and other life-sustaining devices. Manufacturers must
