ANSI AAMI 11138-5 pdf free download

ANSI AAMI 11138-5 pdf free download.Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes.
4 Test organism 5.1 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganisms of demonstrated equivalent performance as required by this document. NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus. NOTE 2 Geobacillus stearothermophilus NCIB 8224, DSM 6790, ATCC 7953, ATCC 1 01 49 and ATCC 1 2980 have been found to be suitable 1 . 5.2 If a test organism other than Geobacillus stearothermophilus is used, the suitability of the resistance of that test organism shall be determined. 5 Suspension The requirements of ISO 1 11 38-1 apply. 6 Carrier and primary packaging 7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in low- temperature steam and formaldehyde sterilization processes shall be demonstrated in accordance with the requirements of ISO 11 1 38-1 :201 7, 5.2 and Annex B. NOTE Carriers based on filter paper might not be suitable because of the chemisorption of formaldehyde on cellulose surfaces.7.2 The exposure conditions to determine compliance shall be the following: a) minimum exposure temperature: greater than or equal to 5 °C above the manufacturer’s stated maximum exposure temperature; b) maximum exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, the maximum exposure temperature shall be greater than or equal to 1 00 °C; c) exposure time: greater than or equal to 1 60 min. NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a low-temperature steam and formaldehyde sterilization process. 7 Inoculated carriers and biological indicators The requirements of ISO 1 11 38-1 apply. 8 Population and resistance 9.1 The resistance characteristics shall be stated according to ISO 1 1 1 38-1 :201 7, 6.4. 9.2 The viable count shall be stated with increments less than or equal to 0,1 × 1 0 n per unit (e.g. per ml of suspension, per inoculated carrier or per biological indicator).
9.3 For inoculated carriers and biological indicators, the viable count shall be greater than or equal to 1 ,0 × 1 0 5 . 9.4 The resistance shall be expressed as the D value in mins at 60 °C. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 60 °C. 9.5 Suspensions, inoculated carriers or biological indicators containing Geobacillus stearothermophilus spores shall have a D 60 value of greater than or equal to 6 min when tested according to the conditions in Annex A. Other microorganisms shall have D values supporting the application. 9.6 The resistance characteristics specified in this document and any other part of ISO 1 1 1 38 shall be defined using the specific critical variables associated with the referenced sterilization process. 9.7 D values are determined according to methods given in ISO 1 1 1 38-1 :201 7, Annexes C and D. 9.8 Determination of D value and survival-kill response characteristics are based on the process parameters in Annex A. 9.9 The survival-kill window should be calculated using the formulae in ISO 1 1 1 38-1 :201 7, Annex E. NOTE This information can be of value to the user when comparing different batches from the same manufacturer. EXAMPLE Using the formulae in ISO 1 1 1 38-1 :201 7, Annex E, with the minimum population and minimum D value requirements specified in this document, the survival-kill response characteristics are — at 60 °C: survival time greater than or equal to 1 8 min and kill time less than or equal to 54 min.ANSI AAMI 11138-5 pdf download.