第 1 章,共 5 章30% 占考试比重

Sterilization Methods and Parameters

Sterilization is the largest single area on the CRCST exam, and it is the part of reprocessing where a small procedural shortcut produces an invisible failure. Sterility cannot be seen, smelled, or tested at the point of use, so the technician's job is to reproduce a validated process exactly. This chapter covers steam sterilization and its cycle types, the low-temperature methods used for heat-sensitive devices, immediate-use steam sterilization and its strict limits, and the loading, drying, and cooling practices that separate a usable load from a wet pack.

How Steam Sterilization Works

Steam sterilization kills microorganisms through moist heat, which coagulates and denatures cellular protein. The killing power comes from condensation: when saturated steam contacts a cooler surface it condenses and releases latent heat directly onto that surface. This is why four conditions must all be satisfied at once. There must be enough time, the correct temperature, moisture in the form of saturated steam, and direct contact between steam and every surface of the device. Pressure is not an independent parameter; it exists only to raise the boiling point of water so that steam can reach 250 or 270 degrees F. Steam quality matters as well. Steam should be roughly 97 percent dry with about 3 percent moisture. Wet steam carries too much water and causes wet packs; superheated steam behaves like hot dry air and loses the condensation mechanism entirely. Steam is the preferred method for any device that tolerates heat and moisture because it is nontoxic, inexpensive, rapid, and the most thoroughly validated process available.

Four parameters must all be met: time, temperature, moisture, and direct contact
Any one of the four failing means the load is not sterile, regardless of what the other three did. Residual soil, a closed box lock, or trapped air all defeat the contact requirement.
AAMI ST79
Time and temperature are inversely related
Higher temperature permits shorter exposure. A gravity cycle needs about 30 minutes at 250 degrees F (121 degrees C) but only about 15 minutes at 270 degrees F (132 degrees C).
AAMI ST79
Steam must be saturated, approximately 97 percent dry
Excess moisture produces wet packs and reduced penetration; superheat destroys the condensation mechanism and dramatically lengthens the time needed for lethality.
AAMI ST79
Sterility assurance level is 10 to the minus 6
This means no more than a one in one million probability that a single processed item remains nonsterile. It is a probability statement, not a count of organisms killed.
AAMI ST79

Gravity vs Dynamic-Air-Removal Cycles

Air is the enemy of steam sterilization because any pocket of residual air is a space steam never reaches. The two main steam cycle types differ entirely in how they remove that air. In a gravity displacement cycle, steam enters the chamber and pushes the cooler, heavier air downward and out through the drain. This works but it is passive and slow, and it struggles with porous loads, lumens, and dense sets. In a dynamic-air-removal cycle, often called prevacuum, the sterilizer uses a vacuum pump to actively pull air out through a series of pulses before steam is admitted, or it uses pressurized steam flushes to achieve the same result. Because air is removed first, steam contacts every surface almost immediately and exposure times drop sharply. A wrapped set that needs 15 minutes in a gravity cycle at 270 degrees F typically needs only about 4 minutes in a dynamic-air-removal cycle at the same temperature. The device manufacturer's written instructions for use always define the required cycle for a specific instrument, and those instructions must be reconciled with what the facility's sterilizer can actually deliver before the device goes into service.

Gravity wrapped set: about 30 minutes at 250 degrees F (121 degrees C), or about 15 minutes at 270 degrees F (132 degrees C)
Passive air removal takes longer. Drying time is added on top of exposure time and is commonly 30 minutes or more for wrapped goods.
AAMI ST79
Dynamic-air-removal wrapped set: about 4 minutes at 270 degrees F (132 degrees C), or about 3 minutes at 275 degrees F (135 degrees C)
Active air evacuation lets steam reach surfaces immediately, which is why exposure is so much shorter than gravity at the same temperature.
AAMI ST79
The device manufacturer instructions for use set the required minimum parameters
Exposure parameters may never be shortened below the validated minimum for local convenience or turnaround pressure. Conflicts are resolved before the device is placed into service.
AAMI ST79
An aborted cycle means the load is unsterile
If the sterilizer cancels, alarms on an air leak, or fails to reach a specified parameter on the printout, the entire load is quarantined and reprocessed, no matter what the chemical indicators show.
AAMI ST79

Low-Temperature Sterilization

Many modern devices contain plastics, optics, adhesives, or electronics that steam would destroy, so low-temperature methods exist to fill that gap. Ethylene oxide is a gas that sterilizes at low temperature and penetrates extremely well, which makes it the option for long, narrow lumens and complex heat-sensitive assemblies. Its trade-offs are severe: it is a recognized carcinogen, requires strict engineering controls and monitoring, and every load must undergo mechanical aeration to drive absorbed residuals out of plastics and rubber before items are safe to handle or use. Hydrogen peroxide gas plasma is much faster and leaves no toxic residue because the sterilant breaks down into water vapor and oxygen, so items are available immediately with no aeration. Its limitation is material compatibility: cellulose materials such as paper, linen, and cotton absorb hydrogen peroxide and will abort the cycle, so only nonwoven polypropylene wrap and approved trays and pouches may be used, and lumen restrictions apply. Ozone sterilizers generate the sterilant on demand from medical-grade oxygen and water and revert to oxygen at the end of the cycle. Dry heat remains the method for anhydrous materials such as oils, ointments, and powders that steam cannot penetrate, using long exposures around 320 degrees F for 2 hours or 340 degrees F for 1 hour. Liquid chemical sterilants such as peracetic acid process immersible devices in circulating solution, but the item emerges wet and unwrapped, so there is no shelf life and it must be used immediately.

Ethylene oxide requires mandatory aeration after every load
Residual EO absorbed into polymers is toxic and must be driven off, typically for 8 to 12 hours or longer at elevated temperature, per the sterilizer and device manufacturer instructions.
OSHA
No cellulose in hydrogen peroxide sterilizers
Paper, linen, cotton, and cellulose-based wraps absorb hydrogen peroxide and cause cycle cancellation. Use only compatible polypropylene wrap, pouches, and containers.
AAMI ST79
Hydrogen peroxide byproducts are water and oxygen
Because there is no toxic residual, loads may be used immediately with no aeration phase, which is the method's major operational advantage over ethylene oxide.
AAMI ST79
Liquid chemical sterilization produces no shelf life
The device comes out wet and unpackaged, so it is transferred aseptically and used right away. It can never be stored for a later case.
AAMI ST79
Choose steam whenever the device tolerates heat and moisture
Low-temperature methods are reserved for devices that cannot survive steam, because every one of them carries cost, cycle time, material restriction, or worker safety burdens.
AAMI ST79

Immediate-Use Steam Sterilization (IUSS)

IUSS is a steam process for items that are needed right away and will be transported directly to the point of use without storage. It is not a shortcut around cleaning. Every item processed by IUSS must first be fully decontaminated using the same cleaning steps as any other device, because a soiled instrument cannot be sterilized by any cycle. IUSS should never be used for reasons of convenience, insufficient instrument inventory, or to save turnaround time. A common IUSS gravity cycle for nonporous metal instruments only is 270 degrees F (132 degrees C) for 3 minutes, while porous items, cannulated devices, and instruments with lumens typically require a longer exposure such as 10 minutes in a gravity cycle, always as specified by the device manufacturer. Implants deserve special attention. Because a failed implant sterilization has permanent consequences for the patient, implants should be terminally sterilized and quarantined until the biological indicator result is known. When an emergency makes IUSS of an implant unavoidable, a process challenge device containing a rapid-readout biological indicator plus a Class 5 integrating indicator is used, the surgeon is informed, the exception is documented, and the biological result is tracked to completion.

IUSS never shortens cleaning
Full decontamination is required first. IUSS shortens only the packaging, drying, and storage steps of the workflow.
AAMI ST79
IUSS items are used immediately and never stored
The item is transported directly to the point of use in a validated containment device. There is no shelf life and no sterile storage for IUSS items.
AAMI ST79
Avoid IUSS for implants
If unavoidable in a documented emergency, use a PCD with a rapid-readout biological indicator and a Class 5 integrating indicator, notify the surgeon, and document the event.
AAMI ST79
Every IUSS cycle is monitored
Physical monitors are reviewed and a chemical indicator is used with each cycle, and the sterilizer is biologically monitored on the schedule set by the standard and facility policy.
AAMI ST79

Loading, Drying, Cooling, and Wet Packs

How a load is arranged determines whether a technically correct cycle actually reaches the instruments. Packages need space so steam can circulate freely, and nothing should touch the chamber walls, where scorching and condensate collection occur. Metal and basin items go on lower shelves and textile packs on upper shelves, because condensate drips down and absorbent textiles beneath metal is a classic wet pack cause. Peel pouches are placed on edge in a rack with paper facing plastic so steam can enter through the porous side and condensate can drain. Rigid containers sit flat and are not stacked unless the container manufacturer has validated stacking. Hinged instruments are placed open on stringers so steam reaches the mating surfaces of the ratchets and box locks. After the cycle, drying and cooling are part of the process, not an afterthought. The load stays undisturbed on the cart in a low-traffic, draft-free area away from air vents until it is fully cool, commonly 30 minutes to an hour or more depending on load density. A package that is damp when handled is considered contaminated, because moisture creates a wicking path from the outer surface to the contents. A wet pack is never dried, wiped, or re-run through a drying phase and then released; the contents are rewrapped and fully reprocessed, and the cause is investigated.

Metal below, textiles above
Condensate drips downward. Placing absorbent textile packs beneath metal trays reliably produces soaked wrappers.
AAMI ST79
Peel pouches go on edge, paper to plastic
Stacking pouches flat or overlapping them traps air and moisture between layers and blocks steam from reaching the porous side.
AAMI ST79
Hinged instruments are sterilized open and unlocked
A closed ratchet creates a shielded metal-to-metal interface that steam cannot penetrate. Use stringers, racks, or instrument pins.
AAMI ST79
A wet pack is a contaminated pack
Moisture wicks microorganisms from the outside of the package to the contents. Reprocess from the beginning; do not air dry, wipe, or re-run only the drying phase.
AAMI ST79
Common wet pack causes
Overloading, dense packing, insufficient drying time, opening the door too early, clogged drains, faulty steam traps, wet incoming steam, and cooling on a cold surface or in a draft.
AAMI ST79
Do not touch or move a load until it has cooled
Handling hot, damp packages drives contamination through the packaging. Cool on the cart, away from vents and traffic, for 30 minutes or longer.
AAMI ST79
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Last updated: July 2026

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