Sterilization

This area has been designed specifically for sterilization professionals in the medical device community.  It serves as a resource on educational offerings, standards and publications, and contacts for other groups involved in medical device sterilization activities.  The site also provides information on FDA and regulations affecting medical device manufacturers.

Resources

Kilmer Conference Proceedings

Johnson & Johnson (J & J) has donated the following published proceedings from the Kilmer Conferences. These conferences brought together leaders in sterility assurance and sterilization. Held every two to three years between 1976 and 2003, the Kilmer Conferences were organized and hosted by J & J. The proceedings from the Kilmer Conferences have been published in eight separate volumes, and they are rich in what they cover. Link here to open and download the Kilmer Collection.

Sterilization Standards

Standards Collections

Get involved in AAMI’s Sterilization Committees

Committees of volunteers are the heart of the AAMI Standards Program. Committee members make recommendations on the need for new standards and other technical publications, determine when a document needs to be revised, draft new documents, and develop committee and public consensus on drafts.

To join:

Resources: Code of Federal Regulations Reference Documents

  • 21 CFR 880.2800, Sterilization process indicator
  • 21 CFR 880.6860, Ethylene oxide gas sterilizer
  • 21 CFR 880.6870, Dry-heat sterilizer
  • 21 CFR 880.6880, Steam sterilizer
  • 21 CFR 880.6885, Liquid chemical sterilants/high level disinfectants
  • 21 CFR 880.6890, General purpose disinfectants