Explanation of the revisions to the ISO 11138 series regarding the manufacture of biological indicators.
This document presents a review of the revisions related to the ISO 11138 series concerning the manufacturing of biological indicators. It explains the changes in the newly revised AAMI/ANSI/ISO 11138 series. Additionally, it details the manufacturing/performance of biological indicators used for sterilization of healthcare products. For any questions, inquiries, or product-related matters, please feel free to contact Leben Japan Co., Ltd. [Contents (Example)] ■ Biological Indicators, Part 1 ■ Biological Indicators, Part 2 ■ Biological Indicators, Part 3 ■ Biological Indicators, Part 4 ■ Biological Indicators, Part 5 *For more details, please refer to the PDF document or feel free to contact us.
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Our company is the importer and distributor of Mesa Labs and Microbiologics in the United States. We handle biological indicators and freeze-dried microbial strains, and we also conduct various tests such as D-value measurement tests, bacterial tests, and sterility tests. Please feel free to contact us if you have any requests.