CRCST Chapter 5 Practice Test: Regulations and Standards
About this chapter
Central service departments operate under a complex web of regulations, standards, and guidelines from multiple organizations. This chapter distinguishes between mandatory regulations (OSHA, FDA, EPA) and voluntary standards (AAMI, AORN, TJC). OSHA enforces workplace safety including the Bloodborne Pathogens Standard that governs PPE use in decontamination. The FDA regulates medical devices and requires tracking of implantable instruments. The EPA registers disinfectant chemicals and oversees proper waste disposal. AAMI publishes technical standards (like ST79 for steam sterilization), while The Joint Commission surveys facilities for compliance. Understanding who enforces what — and the difference between a regulation you must follow and a standard you should follow — is essential for daily decision-making and audit readiness.
AAMI (Association for the Advancement of Medical Instrumentation) is best described as: