IAHCSMM CRCST EXAM CORRECT 100%

Statute - ANSWER A written law adopted by a legislative body that governs a city, county, state or country Regulation - ANSWER Rules issues by administrative agencies that have the force of law Standard - ANSWER A uniform method of defining basic parameters for processes, products, services, and measurements Regulatory Standards - ANSWER A comparison benchmark that is mandated by a governing agency. Noncompliance with regulatory standards may lead to citations and legal penalties Voluntary Standards - ANSWER Guidelines or recommendations for best practices to provide better patient care. Industry, nonprofit organizations, trade associations and others develop these. Best practice - ANSWER A method or technique that has consistently shown results superior to those achieved by other means. Class I Medical Devices - ANSWER low risk devices such as hand-held surgical instruments and ultrasonic cleaners; subject to "general controls" but most exempt from pre-market notification approval (501k) Class II Medical Devices - ANSWER considered to pose potential risks great enough to warrant higher regulation; includes most types of sterilizati