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BERKSHIRE INTERNATIONAL follows ANSI/AAMI/ISO 11137 American National Standards for its Sterilization Validation Process.
The standards document, ANSI/AAMI/ISO 11137, Sterilization of Health Care Products—Radiation: Requirements for Development, Validation and Routine Control of a Sterilization Process for Medical Devices, incorporates the sterilization methodologies of the International Organization for Standardization (ISO) and the American National Standards Institute. (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.”
A network of national standards institutes from 148 countries working in partnership with international organizations, governments, industry, business and consumer representatives.