Sterile Processing Standards and Regulations
Updated October 27, 2026
Sterile processing work is guided by standards and regulations from several organizations. The CRCST exam expects you to know who does what. Here’s a quick reference, followed by free practice questions.
Who does what
| Organization | Role in sterile processing |
|---|---|
| AAMI (Association for the Advancement of Medical Instrumentation) | Writes the standards and practices for reprocessing, such as ST79 for steam sterilization and ST91 for flexible endoscopes |
| OSHA (Occupational Safety and Health Administration) | Protects workers, for example through the Bloodborne Pathogens Standard and rules on chemical hazards |
| FDA (Food and Drug Administration) | Regulates medical devices, sterilizers, sterilization packaging and high-level disinfectants, and clears device instructions for use |
| EPA (Environmental Protection Agency) | Registers many disinfectants for environmental surfaces, and regulates some sterilant emissions |
| CDC (Centers for Disease Control and Prevention) | Publishes infection prevention guidelines, such as its guideline on disinfection and sterilization |
| The Joint Commission | Accredits hospitals and surveys how they follow standards |
Instructions for use (IFU)
The device manufacturer’s instructions for use explain how to clean, inspect, package and sterilize each device. Following the IFU is essential, and it comes before general habits or shortcuts.
Free practice questions
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Which organization writes standards such as ST79 for steam sterilization?Answer: BAAMI develops sterile processing standards, including ST79 for steam sterilization and ST91 for flexible endoscopes.
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Which agency's rules focus on protecting workers, such as the Bloodborne Pathogens Standard?Answer: AOSHA protects worker safety, including through the Bloodborne Pathogens Standard and chemical hazard rules.
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Which agency regulates medical devices and sterilizers?Answer: DThe FDA regulates medical devices, including sterilizers, packaging and high-level disinfectants.
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What does a device's IFU provide?Answer: BThe instructions for use explain exactly how to reprocess the device, and following them is essential.
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Which organization accredits hospitals and surveys their compliance with standards?Answer: AThe Joint Commission accredits health care organizations and surveys how they meet standards, including in sterile processing.
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Which agency publishes infection prevention guidelines, such as a guideline on disinfection and sterilization?Answer: CThe CDC publishes infection prevention guidelines that sterile processing departments use alongside AAMI standards.
Pass the CRCST exam on your first try
- All 207 questions on decontamination, disinfection, instruments, packaging, sterilization, storage, patient care equipment and professional skills
- An explanation for every answer, with the AAMI standard, CDC guideline or OSHA rule behind it
- Unlimited full 125-question practice exams, with each domain in its real share