EUROLAB laboratory provides testing and compliance services within the scope of the AAMI TIR33 standard. This standard describes a method of confirming a dose selected for a sterility assurance level (SAL).
This sterilization dose verification method can be used to meet product qualification requirements set out in ANSI/AAMI/ISO 11137.
This TIR is considered informative and the use of terms, etc. should only be considered in the context of this TIR. That is, if it is decided to use this method of proof, it must be followed in accordance with the requirements (will be done) and recommendations (must) set out in this TIR.
This standard, as described, is for verification of stated doses only and cannot be used to justify other sterilization doses. The method cannot be used to validate a selected dose when the average bioburden estimate of the entire product unit does not meet the requirements for the selected dose.
EUROLAB assists manufacturers with AAMI TIR33 test compliance. Our test experts, with their professional working mission and principles, provide you, our manufacturers and suppliers, the best service and controlled testing process in our laboratories. Thanks to these services, businesses receive more effective, high-performance and quality testing services and provide safe, fast and uninterrupted service to their customers.
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EUROLABreporting and certification activities, United Accreditation Foundation (UAF), Turkish Accreditation Agency (TÜRKAK) ve Enterprise Accreditation Foundation (EAF) based on the accreditation provided by the accreditation body. The Enterprise Accreditation Foundation (EAF) accreditation body is also a signatory of the United Nations (UN GLOBAL COMPACT) organization.
