ANSI AAMI ST21 pdf free download

ANSI AAMI ST21 pdf free download.Sterilization of health care products-Biological indicators- Part 2: Biological indicators for ethylene oxide sterilization.
5 Test organisms The test organisms shall be spores of Bacilus subtilis or other strains or organisms of demonstrated equivalent performance as required by this part of ANSI/AAMI ST21. NOTES- Bacillus subtilis NCTC (National Collection of Type Cultures [of the U.K. Central Public Health Laboratory]) 10073 and CIP (Collection of the Institut Pasteur) 7718, and B. subilis ATCC (American Type Culture Collection) 9372 and NRRL (Northern Regional Research L .aboratory [of the Northern Utilization Research and Development Division of the U.S. Department of Agriculture]) B 4418 have been found to be suitable. 2. If an organism other than B. subtilis is used, then the suitability of the resistance of the test organism chosen should be determined during process qualification.
8 Biological indicators (Bis)
8.1 The number of recoverable test organisms on each BI shall be controlled during manufacture to be either within ± 50% of the nominal population stated by the manufacturer or within the minimum and maximum populations stated by the manufacturer.
8.2 Retrospective determination of the count shall be made by performing a viable test organism count under the manufacturer’s stated culture conditions on a suspension of test organisms obtained by physical removal of the test organisms from the carrier through ultrasonication, shaking with glass beads, or other appropriate validated methods. Counts obtained shall be regarded as acceptable if they are within — 50% and + 300% of the stated value or, if minimum and maximum populations are stated by the manufacturer, within those stated minimum and maximum populations.
8.3 For inoculated carriers and BIs intended for use in routine monitoring, the nominal population shall not be less than 1 x 106 stated in increments no greater than 0.1 x 106.
NOTE—Inoculated carriers and BIs intended for other purposes (e.g., qualification, validation, or other specific tests) could require other nominal populations. Other inoculum levels may be utilized for routine monitoring of industrial ethylene oxide processes, provided that level has been shown to be appropriate during process qualification.
9 Resistance
9.1 Resistance performance testing shall be performed as required in ANSI/AAMI ST59, Sterilization of health care products—Biological indicators—Part 1: General, section 5.
9.2 The manufacturer shall state the D-value of each batch of BIs or inoculated carriers to an accuracy of ± 0.5 minutes.
9.3 Determination of the resistance characteristics of each batch of BIs shall be performed according to ANSI/AAMI ST44:1 992, BIER/EQ gas vessels.
9.4 The D-values obtained by either the survivor curve method and/or by the fraction negative analysis using the Most Portable Number (MPN) procedure (see ANSI/AAMI ST59, annexes B, C, D, and G) for test organism populations on the BI shall be not less than 12.5 minutes (mm) when exposed to 600 mg/I ± 30 mg/I ethylene oxide at 60% ± 10% relative humidity and 30° C ± 10 C, and/or 2.5 mm if the test conditions are the same except temperature is controlled to 54° C ± 10 C.
NOTE—If an organism other than B. subtillis is used, then the resistance of that organism at the sterilizing conditions should be known, and the suitability of the resistance determined. This determination should be made by the user during process qualification.
10 Test methods
Test methods given in this standard are reference methods. When alternative method(s) are used, these shall be defined, validated, and have proven correlation with the reference method(s).
ANSI AAMI ST21 pdf download.