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Dental Autoclave: What It Is and How CDC Says to Monitor It

What a dental autoclave is, its FDA Class II status, and what CDC says to monitor each load, package and week, including a positive spore test.

Written and maintained by CASRAI Editorial Board

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This page describes products and general use; it is not medical advice.

A dental autoclave is a steam sterilizer used in dental practices to sterilize heat-tolerant instruments with pressurized steam. It is used by dental clinic staff, infection-control leads and the people who buy and maintain their equipment. After reading, you should know what the device is in regulatory terms and what CDC says a dental practice must monitor on every load, every package and every week.

What a dental autoclave is

A dental autoclave is a steam sterilizer sized and used for dental instruments. Under US federal regulation, 21 CFR 880.6880 defines a steam sterilizer (autoclave) as a device intended for use by a health care provider to sterilize medical products by means of pressurized steam, and classifies it as Class II (performance standards). The terms “autoclave” and “steam sterilizer” therefore name the same kind of device. For the general principle, see what an autoclave is.

Who uses it: dental offices and other clinics that reprocess reusable instruments. CDC’s dental guidelines say that because most semicritical items in dentistry are heat-tolerant, they should be sterilized by heat (CDC, Guidelines for Infection Control in Dental Health-Care Settings, 2003, MMWR RR-17).

How it fits into instrument reprocessing

The autoclave is one step in a sequence. The same CDC guideline states that cleaning should precede all disinfection and sterilization processes, and that critical and semicritical instruments that will be stored should be wrapped or placed in containers. In practice the chamber is the middle step: clean, package, sterilize, then store. Cycle temperatures and times are set by the sterilizer manufacturer’s instructions; see autoclave sterilization temperature for the general figures. Packaging options are covered in sterilization pouches.

CDC’s dental summary also lists reported breakdowns in practice, including failure to heat-sterilize handpieces between patients and failure to monitor autoclaves, with spore testing given as the example. See dental handpiece types for the instruments most often involved.

Types and variants

Dental autoclaves are most often described by chamber type and by the EN 13060 classes (Class N, S and B) used outside the US. Rather than repeat those definitions here, see types of autoclaves and the comparison Class B vs Class N autoclave. Steam is one of several methods; sterilization technology compares them.

What the rules mean for a dental sterilizer

  • The device is regulated as a steam sterilizer, Class II, under 21 CFR 880.6880.
  • CDC calls for checking gauges, displays or printouts for pressure, temperature and exposure time on every load, against the manufacturer’s levels, so the unit needs to give a readable record of those values.
  • CDC does not provide a separate recommendation for sterilizers that are used on a part-time basis, so a lightly used unit is monitored the same way.

Monitoring and records: what CDC says

CDC’s page Best Practices for Sterilization Monitoring in Dental Settings (dated May 15, 2024) sets out three kinds of monitoring.

Monitor How often What CDC says
Mechanical (gauges, displays, printouts) Every sterilizer load Confirm pressure, temperature and exposure time met the manufacturer’s levels; document it.
Chemical indicator Inside every package Checked when the package is opened for the expected colour change.
Biological indicator (spore test) At least weekly, and with every load containing an implantable device Use a matching control from the same lot as the indicator.

Mechanical, chemical and biological records are kept long enough to meet state and local rules. This is why the chemical indicators and the Helix test pages are worth reading alongside this one.

What a positive spore test means

CDC says a single positive spore test probably does not indicate sterilizer malfunction if the mechanical and chemical indicators were normal. A repeat positive is treated as a sign the sterilizer needs inspection or repair, as set out on the CDC page above.

Common mistakes

  • Skipping the weekly spore test on a part-time unit. CDC makes no exception for part-time use.
  • Relying on the external indicator alone. CDC calls for an indicator inside every package.
  • Not heat-sterilizing handpieces between patients, one of the breakdowns CDC reports.
  • Not keeping the records long enough for state and local requirements.

FAQ

Is a dental autoclave the same as a dental sterilizer?

For steam units, yes. The US regulation names the device a “steam sterilizer (autoclave)”. “Sterilizer” is the wider word and also covers non-steam methods; see sterilization technology.

Is a podiatry autoclave different?

The device class is the same: a steam sterilizer regulated under 21 CFR 880.6880 for health care providers. CDC’s monitoring page is written for dental settings, so podiatry practices should follow the guidance that applies to their own setting and their sterilizer maker’s instructions.

How often must a dental autoclave be spore tested?

CDC says a spore test should be used at least weekly, and for every load that includes an implantable device.

Do part-time sterilizers need less testing?

CDC does not give a separate recommendation for sterilizers used part-time.

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