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Home >> Learning Center >> Medical Device >> Sterilization Validations


A common goal of medical device manufacturers is to produce safe products. Sterility is essential to the safety of many medical devices. Most single use devices are terminally sterilized by ethylene oxide gas, gamma radiation, or electron beam radiation.

What are Sterilization Validations?

Every product that is to be sterilized must have the chosen sterilization method validated to ensure that is does, in fact, reliably reduce bioburden on the pre-sterilized product to an acceptable level. This process is called a sterilization validation.

This is a different process from sterility testing, which are routine tests done to ensure sterility of a lot of product.

Bioburden and Sterilization Validations

To help device engineers better understand how a sterilization validation is performed, and how bioburden and sterilization are connected, Pacific Biolabs and Nutek Corporation created a webinar on bioburden and sterilization validations.

The recorded version of the webinar is available here.

FDA Requirements

By means of the cGMP medical device regulations, FDA has established some of the requirements for an acceptable sterility assurance program. More specific guidelines for validation of the sterilization processes are developed and published by AAMI in conjunction with ISO. We recommend that clients review current AAMI publications which pertain to the method of sterilization used for their products. Some of the more relevant publications are listed below. To obtain these documents, contact AAMI by phone at 703-525-4890 or 800-332-2264, or email www.aami.org.

The FDA Center for Devices and Radiological Health (CDRH) can provide assistance to medical device manufacturers. The CDRH Section of the FDA website has extensive information on a variety of topics, including the following:

  • GMP issues
  • Sterility and Biocompatibility
  • 510K, PMA, IDE
  • Electronic Docket /Facts-on-Demand
  • Publications only
  • In Vitro Diagnostic Products
FDA CDRH – Rockville, MD
800-638-2041 or 301-443-6597
Fax: 301-443-8818

Download printable version of our booklet Sterility Assurance Compliance - A Guide for Medical Device Manufacturers (PDF).


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