The purpose of the Statim cassette chamber is to provide a sterile barrier system

Statim unwrapped sterilization is safely practiced worldwide by professional body piercers. Outside the practice of medicine, jewelers are using the Statim for steam sterilization for ear and body piercing. The new, cleaned jewelry and other items needed for the procedure are selected for the customer and sterilized unwrapped in the Statim along with a class … Read more The purpose of the Statim cassette chamber is to provide a sterile barrier system

Processing Devices

Standards are useful, and guidance based on evidence is often even more so.

Scope

This guidance provides recommendations regarding reuse instructions in labeling for reusable medical devices and the validation of the recommended reprocessing process in the instructions. The recommendations are applicable to the three device reprocessing situations below.

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