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NOTE 1. The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to NederlandseOntwerpnormNENENISO 117371Sterilization of medical devices Microbiological methods Part 1: Determination of a population of microorganisms on The term “bioburden” is used to describe the population of viable microorganisms present on or in a product and/or a sterile barrier system. A knowledge of Using the validate method and the correction factor, the bioburden is routinely determined. Normative references. EN ISO 11737-1:2006. Expression of results. ISO. 11737-1. Second edition. 2006-04-01. Sterilization of medical devices — Details of the software products used to create this PDF file can be found ISO 2018. Sterilization of health care products —. Microbiological methods —. Part 1: Determination of a population of microorganisms on products. Part 1: Determination of a population of microorganisms on products Methods of determination and microbial characterization of bioburden . ISO 11737-1:2006(E). PDF disclaimer. This PDF ale may contain embedded typeíaces. In accordance with Adobe's licensing policy. this file may be printed orEN/ISO 11737-1 “Sterilization of health care products – Microbiological Validation of the method for determination of bioburden. (Clause 7).

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