ANSI AAMI ST21-1999 pdf download Sterilization of health care products Biological indicators- Part 2: Biological indicators for ethylene oxide sterilization
This American National Standard provides specific requirements for test organisms and biological indicators (BIs) intended for use in assessing the performance of sterilizers employing pure ethylene oxide gas or admixtures of the gas with diluent gases at sterllizing temperatures within the range of 20° C to 65° C. Compliance with this standard necessitates compliance with ST59, Sterilization of health care products Biological indicators Part 1: General.
2 Normative references
The fllwing standards contain provisions which, through reference in this text, constitute provisions of ANSI/AAMI ST21. At the time of publication, the editions indicated were valid. All standards are subject to revision, and parties to agreements based on ANSI/AAMI ST21 are encouraged to investigate the possibility of applying the most recent edition of the standard indicated below.
The American National Standards Institute maintains a register of currently valid American National Standards. ANSI/AAMI ST59:1999, Sterilization of health care products Biological indicators- Part 1: General ANSIAAMI ST44:1992, BIER/EO gas vessels
3 Definitions For the purposes of this American National Standard, the definitions given in ANSI/AAMI ST59 apply.
4 General The requirements of ANSI/AAMI ST59 shall apply, except as modified in the subsequent clauses of this American National Standard.
5 Test organisms The test organisms shall be spores of Bacillus subtilis or other strains or organisms of demonstrated equivalent performance as required by this part of ANSIAAMI ST21. NOTES- 1. Bailus subtiis 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 (Northerm Regional Research Laboratory [of the Northern Uillization Research and Development Division of the U.S. Department of Agriculturel]) B 4418 have been found to be suitable. 2. If an organism other than B. subilis is used, then the suitability of the resistance of the test organism chosen should be determined during process qualification.
6 Suspensions Replicate determinations of the viable test organism count on the same batch of suspension shall be within t 35% of the nominal population.
7 Carrier and primary packaging For specific requirements for the carrier and primary packaging, see ANSI/AAMI ST59, subclause 4.4.