ANSI AAMI 11138-2-2017 pdf download.
ANSI AAMI 11138-2-2017 pdf download.Sterilization of health care products—Biological indicators
1 Scope
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators and test methods intended for use in assessing the performance of sterilizers and sterilization processes employing ethylene oxide gas as the sterilizing agent, either as pure ethylene oxide gas or mixtures of this gas with diluent gases, at sterilizing temperatures within the range of 29 °C to 65 °C.
NOTE 1 Requirements for validation and control of ethylene oxide sterilization processes are provided by ISO 1 1 1 35 and ISO 1 4937.
NOTE 2 National or regional regulations can provide requirements for work place safety.
2 Normative references
The following documents are referred to in the text in such a way that some or all of their content constitutes requirements of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
ISO 11 1 38-1:201 7, Sterilization of health care products—Biological indicators—Part 1: General requirements
ISO 18472, Sterilization of health care products—Biological and chemical indicators—Test equipment
3 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1 1 1 38-1 apply.
ISO and IEC maintain terminological databases for use in standardization at the following addresses:
— IEC Electropedia: available at http://www.electropedia.org/
— ISO Online browsing platform: available at https://www.iso.org/obp/
4 General requirements
The requirements of ISO 1 1 1 38-1 apply.
5 Test organism
5.1 The test organisms shall be spores of Bacillus atrophaeus, Bacillus subtilis or other strains of microorganisms of demonstrated equivalent performance as required by this document.
NOTE 1 Some strains of Bacillus subtilis have been reclassified as Bacillus atrophaeus.
NOTE 2 Bacillus atrophaeus ATCC 9372, NCTC 1 0073, NCIMB 8058, DSM 2277, NRRL B-441 8 and CIP 77.1 8 have been found to be suitable 1 .
5.2 If a test organism other than Bacillus atrophaeus is used, the suitability of the resistance of that test organism
shall be determined.
6 Suspension
The requirements of ISO 1 1 1 38-1 apply.
7 Carrier and primary packaging
7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in ethylene oxide sterilization processes shall be demonstrated in accordance with the requirements of ISO 1 11 38-1 :201 7, 5.2 and Annex B.
7.2 The exposure conditions to determine compliance shall be
a) minimum exposure temperature: greater than or equal to 55 °C,
b) sterilizing agent: ethylene oxide gas at a concentration not less than 800 mg/l in air at greater than or equal to 70 % RH,
c) maximum exposure temperature: as stated by the biological indicator manufacturer, and
d) exposure time: greater than or equal to 6h.
NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of an ethylene oxide sterilization process.
8 Inoculated carriers and biological indicators
The requirements of ISO 1 1 1 38-1 apply.
9 Population and resistance
9.1 The manufacturer shall state the resistance characteristics in accordance with ISO 1 1 1 38-1 :2017, 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 6 .
9.4 The resistance shall be expressed as the D value in minutes, at 54 °C. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes, to one decimal place at 54 °C.
9.5 Suspensions, inoculated carriers or biological indicators containing Bacillus atrophaeus spores shall have a D value of not less than 2,5 min at 54 °C when tested according to the conditions in Annex A using test gas mixtures (see Annex B). Other microorganisms shall have D values supporting the application.
