|US FDA sec. 880.6880 Steam sterilizer.|
|(a) Identification. A steam sterilizer (autoclave) is a device that is intended for use by a health care provider to sterilize medical products by means of pressurized steam.
(b) Classification. Class II (performance standards).
Acme Revival has specific procedures, refurbishment guidelines, and quality testing protocols for Steam Sterilizers / Autoclaves
All Steam Sterilizers (Autoclaves) undergo specific quality controls to ensure your refurbished device is safe, effective, and operating to the specifications designated by the manufacturer.
1). The chamber is inspected, polished, and cleaned:
Acme Revival does not fulfill devices with chambers showing signs of corrosion, pitting or other defects that could jeopardize the integrity of the chamber’s structure.
The inner chamber is polished to a high luster finish and any dried media on the surface is removed with orbital rotary power tools at 6700 revolutions per minute. We then use highly concentrated Citric Acid to clean and descale the chamber reservoir, chamber itself, and tubing. We then flush the system using distilled water prior to preparing for shipment.
2). Hydrostatic Testing (Pressure + Temperature)
We pressurize the system to at least ¹51 psi for 30 consecutive minutes and ensure steady temperature and consistent pressure to ensure a leak-free system, operating to factory specifications.
3). Chemical Spore Testing
We use in-facility chemical spore testing to ensure all internals are free from highly resistant bacteria and fungus. All Steam Sterilizers have been out of use for at least 7 days prior to refurbishment.
4). ASME Certification (issued to original manufacturer)
Any container that can be pressurized can be dangerous—and that includes Autoclaves. For decades, the American Society of Mechanical Engineers (ASME) has maintained a rigorous set of technical standards to assure the safety of all sorts of pressure vessels and fittings. These apply to every step of that item’s manufacturing and testing, and have become the accepted hallmark of safety and reliability.
In order to earn an ASME stamp, an item must be manufactured in a facility, and using a process, that third-party inspectors have verified conforms to the ASME Boiler and Pressure Vessel Code. That inspection starts with the sourcing of individual components and base materials, and culminates with final hydrostatic testing to demonstrate that the ASME-stamped pressure chamber will actually perform as expected under real-world conditions.
Acme Revival only sells ASME certified Autoclaves and Steam Sterilizers. If you are unsure whether the device you’re looking at purchasing is ASME certified, please contact the Acme Help Desk.
5). All electronic components are tested and verified
Acme Revival only uses original, authentic parts to replace electronic components that are in need of replacement. We verify that every aspect of the steam sterilizer is operating to factory specifications.
¹Maximum pressure values may depend on type, size, shape, age, and/or manufacturer of sterilizer.
²Acme Revival may not perform any additional refurbishment, repair, or cleaning than what is listed above. It is ultimately the responsibility and duty of the clinician to verify, daily, that their device is properly working and to ensure safe patient use per the manufacturer’s specifications. Regular maintenance should be performed as detailed in the manufacturer’s official operator/user manual, and, as indicated by this official document, regular self-calibrations, cleanings, and self-checks should be performed.