Berkshire follows ANSI/AAMI/ISO 11137-2006 American National Standards for our Sterilization Validation Process.

Berkshire Process Validation Flow Chart

The standards document, ANSI/AAMI/ISO 11137 - 2006 , Sterilization of health care products-Requirements for validation and routine control-Radiation sterilization, incorporates the sterilization methodologies of the International Standards Organization (ISO) and the American National Standards Institute, Inc. (ANSI). The document, published by the Association for the Advancement of Medical Instrumentation (AAMI), provides unanimity between the international standards for medical device sterilization and the guidelines for gamma and electron beam radiation previously followed by device manufacturers in the United States.

The American National Standards Institute (ANSI) is a private, non-profit organization (501(c)3) that administers and coordinates the U.S. voluntary standardization and conformity assessment system. The Institute's mission is to enhance both the global competitiveness of U.S. business and the U.S. quality of life by promoting and facilitating voluntary consensus standards and conformity assessment systems, and safeguarding their integrity.

The Association for the Advancement of Medical Instrumentation (AAMI) is a unique alliance of professionals and organizations dedicated to the understanding and beneficial use of medical device technology. AAMI members include health care institutions, research and teaching facilities, government agencies, manufacturers, test houses, trade associations and individual health care professionals.

A network of national standards institutes from 148 countries working in partnership with international organizations, governments, industry, business and consumer representatives. A bridge between public and private sectors.