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Direct comparison
Sterilization vs Pasteurization for Devices
Sterilization vs pasteurization for medical devices: spores, sterility assurance level, Spaulding categories and the CDC efficacy caveat, side by side.
Written and maintained by CASRAI Editorial Board
Last updated
How do Sterilization and Pasteurization compare side by side?
The table below compares Sterilization and Pasteurization across 10 dimensions, from what it is (cdc definition) to when to pick each.
Side-by-side comparison
| Dimension | Sterilization | Pasteurization |
|---|---|---|
| What it is (CDC definition) | A validated process used to render a product free of all forms of viable microorganisms. | Heating of milk, wine or other liquids to 65-77 °C (or the equivalent) for about 30 minutes to kill or markedly reduce pathogenic and spoilage organisms other than bacterial spores. CDC: "not a sterilization process". |
| Bacterial spores | Within the process goal: the endpoint is the absence of all viable microorganisms. | Not destroyed. CDC: pasteurization "does not destroy bacterial spores". |
| Stated purpose | Make the item sterile. | Destroy pathogenic microorganisms. In health care it counts as disinfection, not sterilization. |
| Sterility assurance level (SAL) | SAL is the probability of a single viable microorganism on a product after sterilization, written 10^-n. CDC describes dual SALs: 10^-6 (for example scalpels, implants) and 10^-3 (for example blood culture tubes, drainage bags). The probability can never be reduced to zero. | No SAL applies; the CDC treats it as a disinfection process that leaves spores. |
| Methods named by the regulator | FDA lists moist heat (steam), dry heat, radiation, ethylene oxide (EtO) gas and vaporized hydrogen peroxide, plus others such as chlorine dioxide gas, vaporized peracetic acid and nitrogen dioxide. | Wet (hot-water) pasteurization; CDC lists it with liquid chemicals as the usual ways health-care objects are disinfected. |
| Time and temperature for devices | The FDA page lists the method families but gives no single time-temperature figure for them. | CDC: hot-water pasteurization is generally about 70 °C (158 °F) for 30 minutes, with water temperature and time monitored as part of a quality-assurance program. |
| Spaulding category it serves | Critical items (enter sterile tissue or the vascular system, such as surgical instruments, cardiac and urinary catheters, implants) "must be sterile". | Semicritical items (mucous membranes or nonintact skin) "minimally require high-level disinfection"; small numbers of bacterial spores are permissible. |
| Device examples in the CDC guideline | Critical items are purchased sterile or steam sterilized if possible; heat-sensitive ones use EtO, hydrogen peroxide gas plasma or liquid chemical sterilants. | Pasteurization of respiratory therapy and anesthesia equipment is "a recognized alternative to chemical disinfection". |
| Efficacy caveat | CDC defines sterilization as a validated process; the probability of a surviving organism can never be reduced to zero. | CDC reports a study with a large inoculum (10^7) of P. aeruginosa and Acinetobacter in respiratory tubing: disinfection failure 6% (machine-assisted chemical) versus 83% (machine-assisted pasteurization). Other investigators found hot-water disinfection effective (more than 5 log10 inactivation). CDC: "Some data challenge the efficacy of some pasteurization units." |
| When to pick each | Choose sterilization when the item is critical (enters sterile tissue or the vascular system) or the requirement is a sterile product. | Pasteurization fits only where high-level disinfection is the requirement, such as respiratory therapy and anesthesia equipment,with monitored time and temperature. |
Sources
- CDC, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008, last update June 2024), https://www.cdc.gov/infection-control/media/pdfs/Guideline-Disinfection-H.pdf
- FDA, Sterilization for Medical Devices, https://www.fda.gov/medical-devices/general-hospital-devices-and-supplies/sterilization-medical-devices
- both read 2026-10-30
- CDC, Guideline for Disinfection and Sterilization in Healthcare Facilities (2008, last update June 2024), https://www.cdc.gov/infection-control/media/pdfs/Guideline-Disinfection-H.pdf , read 2026-10-30
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Common questions
Common questions about Sterilization vs Pasteurization
What is the difference between sterilization and pasteurization?
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Sterilization is a validated process that renders a product free of all forms of viable microorganisms. Pasteurization uses heat to destroy pathogenic organisms but does not destroy bacterial spores, so the CDC says it is not a sterilization process (CDC, read 2026-10-30).
Does pasteurization kill bacterial spores?
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No. The CDC guideline states that pasteurization does not destroy bacterial spores, which is why it is classed as disinfection rather than sterilization.
Is pasteurization ever used on medical equipment?
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Yes, for some semicritical items. The CDC calls pasteurization of respiratory therapy and anesthesia equipment a recognized alternative to chemical disinfection, generally about 70 °C (158 °F) for 30 minutes with monitoring, while noting that some data challenge the efficacy of some pasteurization units.
Which medical devices must be sterile?
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Under the Spaulding classification in the CDC guideline, critical items that enter sterile tissue or the vascular system, such as surgical instruments, cardiac and urinary catheters and implants, must be sterile.
Going deeper
