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Sterilization of health care products. Biological indicators. Guidance for the selection, use and interpretation of results
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Available format(s): Hardcopy, PDF
Superseded date: 01-05-2019
Language(s): English
Published date: 31-01-2010
Publisher: British Standards Institution
Foreword Introduction1 Scope2 Normative references3 Terms and definitions4 General5 Characteristics of biological indicators6 Selection of supplier7 Biological indicators in process development8 Biological indicators in sterilization validation9 Biological indicators in routine monitoring10 Results11 Application of biological indicator standards12 Culture conditions13 Third-party requirements14 Personnel training15 Storage and handling16 Disposal of biological indicatorsAnnex A (informative) - Microbiological inactivation kinetics and enumeration techniquesAnnex B (informative) - Process challenge devicesAnnex C (informative) - Formulae for fraction negative methods for D value calculationsAnnex D (informative) - Examples of documentation for biological indicators prepared by the userAnnex E (informative) - Calculation of z valueAnnex F (informative) - D value determination by survivor curve methodAnnex G (informative) - Survival-kill response characteristicsBibliography
Specifies guidance for the selection, use and interpretation of results from application of biological indicators when used in the development, validation and routine monitoring of sterilization processes.
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