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STERILIZATION OF HEALTH CARE PRODUCTS - CHEMICAL INDICATORS - PART 4: CLASS 2 INDICATORS AS AN ALTERNATIVE TO THE BOWIE AND DICK-TYPE TEST FOR DETECTION OF STEAM PENETRATION
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Available format(s): Hardcopy, PDF
Language(s): English
Published date: 01-01-2007
Publisher: National Standards Authority of Ireland
For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.Only cited Standards give presumption of conformance to New Approach Directives/Regulations.Dates of withdrawal of national standards are available from NSAI.
ForewordIntroduction1 Scope2 Normative references3 Terms and definitions4 General requirements5 Indicator system format6 Performance requirements7 Packaging and labelling8 Quality assuranceAnnex A (normative) Determination of indicator strength during and after steam sterilizationAnnex B (normative) Standard test cyclesAnnex C (normative) Estimation of visual difference between colour of the substrate and of the changed or unchanged indicator system by determination of relative reflectance densityAnnex D (normative) Determination of uniform colour change on exposure to saturated steamAnnex E (normative) Determination of equivalence of the alternative indicator to the Bowie and Dick testAnnex F (normative) Determination of reproducibility of fail conditions created in a standard test pack by air injection, air leak and retained air systemsAnnex G (normative) Determination of indicator colour change on exposure to dry heatAnnex H (normative) Determination of shelf life of productAnnex I (normative) Accelerated ageing of test samplesAnnex J (normative) Steam exposure apparatus and steam for test purposesAnnex K (normative) Standard test packAnnex L (normative) Air injection systemBibliography
Describes the performance for a Class 2 indicator to be used as an alternative to the Bowie and Dick-type test for steam sterilizers for wrapped health care goods (instruments, etc., and porous loads).
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