BS EN ISO 10993 looks at the biological analysis and testing of sterile equipment by specifying the allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrins (ECH). The standard also focuses on measurement procedures and methods to show compliance before the medical equipment is released. By following the specifications of BS EN ISO 10993, organizations can reduce biological and chemical hazards, and implement best practice safety measures. Additional background information, with guidance and a flowchart to demonstrate how to use this standard, is also included.
BS EN ISO 10993 first categorises the medical equipment before looking at the allowable limits and determination of EO and ECH residuals. It explains factors that should be taken into account when releasing products and defines the evaluation of gas chromatograms. Other topics include solvent extraction methods, aqueous extraction methods and the ideal testing conditions.
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EN ISO 10993-7:2008/AC:2009
ISO 10993-7:2008/Cor 1:2009