FDA guidance on sterilizers

A bit of light reading in FDA guidance documents on sterilizers and validation for hollow items which is critical to their use for tattoo and piercing facilities:

Simulated Use Tests

6steps artificial test soilSterilizer microbicidal performance must be tested under simulated use conditions. The applicant must justify how the simulation correlates to in-use worst case conditions.

Select a representative sample of medical products indicated in labeling. The tests must consist of replicates of devices and types of materials that are indicated for sterilization, e-g., metals, polymers, elastomers, adhesive resins, paper, and fabrics. The articles.selected for each material should exhibit design configurations that will provide the greatest challenge to ‘penetration of the sterilant, e-g., lumens, mated surfaces, hinges, gnarled surfaces. Test loads should be as noted in labeling, packaged properly, and oriented according to labeling.

The test articles must be inoculated with a 106 CFU/unit of the most resistant test organism prepared with an inorganic and orqanic load. Allow the inoculum to dry on the article before placement in the sterilizer. The inocula must be placed in various locations on the test articles including those least favorable to penetration and contact with the sterilant, e.g., lumens, mated surfaces, hinges. Include controls for each type of article.

In Use Tests

Sterilizer performance must also be verified under in-use conditions. Articles sampled.after use should be precleaned (or decontaminated) according to the normal operational reprocessing protocol of the health care facility where the samples are obtained. Assurance of meeting a stringent precleaning protocol is not a precondition since the robustness of the sterilization process is part of this evaluation. Multiple tests with differing load conditions as indicated in labeling should be reported.

After processing, the test articles are neutralized, if necessary. The articles are immersed in the growth media, if possible, or subjected to an extraction method with the extract placed in growth media. Publications and the literature contain suitable extraction methods.


Did you know that all of the steam sterilizers approved for use on the market in the US are listed here?

  • Search: “steam sterilizer” in the device field.
  • For more information search: Regulation Number 880.6880


In this you’ll find useful information such as if the sterilizer is approved for items with lumens: hollow instruments.

This autoclave can not sterilize hollow instruments.
This autoclave can not sterilize hollow instruments.

Device Name:  Prestige Medical Series 2100 Clinical Autoclaves

Indications for Use:

The Models 2100 06 and 2100 07 Clinical Autoclaves are intended to sterilize unwrapped solid instruments (i.e., excluding lumened instruments and dental handpieces) and non-porous loads at cycle parameters of 121° Celsius saturated steam process for 18 minutes


Nice to know that this and many other popular economy autoclaves are clearly not approved for sterilizing hollow items.

Another reason to choose the Statim and Bravo autoclaves: they are designed and approved for sterilizing devices with lumens, meaning that they are appropriate for hollow body art instruments.

Get a STATIM or BRAVO autoclave

The STATIM autoclaves are approved for sterilizing hollow items
The STATIM autoclaves are approved for sterilizing hollow items

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