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Have a question? Call us: 
+1 (801) 290-7500
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New Guidance on Product Family Adoption for Radiation Sterilization: TIR 35:2016

Event

Apr 26, 2018 to Oct 20, 2018

Location

Online

Contact Information

Customer Service
801-290-7500




Product family grouping is discussed in Clause 4 of ANSI/AAMI/ISO 11137-2:2013 entitled ‘Sterilization of health care products – Radiation – Part 2: Establishing the sterilization dose’. This document is designed to provide general requirements and guidance for establishing a product family for radiation sterilization. Family grouping is commonly used in the industry so that not every product type manufactured needs to be tested. AAMI’s Technical Information Report (TIR) 35 originally addressed alternative sampling plans for radiation sterilization using Method 1 and Method 2. When it was due for revision, the AAMI committee decided it would be an opportunity to provide additional guidance to the industry regarding different approaches that could be used for product family adoption. In 2016, AAMI TIR35 was published and entitled ‘Sterilization of health care products— Radiation sterilization— Product adoption and alternative sampling plans for verification dose experiments and sterilization dose audits’. This TIR contains additional information on how to adopt a product into an existing family. This webinar will discuss the concepts found in this document and provide examples of how the guidance might be applied.

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