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.”
The American National Standards Institute Inc. (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.
The International Organization for Standardization (ISO) is a network of national standards institutes from 165 countries working in partnership with international organizations, governments, and industry, business, and consumer representatives. It provides a bridge between public and private sectors with the goal of establishing state-of-the-art specifications for products, services, and good practice.
BERKSHIRE CORPORATION was the first US manufacturer of contamination control products to receive the certificate of registration to an ISO 9001 standard. Berkshire prides itself on its ongoing commitment to quality.
ISO 9001 is an international standard of quality management and quality assurance. It lays the foundation for companies to effectively document the quality system elements to be implemented for an efficient quality system.
This process ensures Berkshire customers are using world’s cleanest, most consistent products — products that are truly “Engineered Clean.”
Certificates Of Registration
Download copies of Berkshire’s respective Certificates of Registration using the links below.