ANSI AAMI ISO 11138-3-2017 pdf download
ANSI AAMI ISO 11138-3-2017 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 sterilization processes employing moist heat as the sterilizing agent.
NOTE 1 Requirements for validation and control of moist heat sterilization processes are provided by the ISO 1 7665 series.
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 1 1 1 38-1 :201 7, Sterilization of health care products—Biological indicators—Part 1: General requirements
ISO 1 8472, 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 http://www.iso.org/obp
4 General requirements
The requirements of ISO 1 11 38-1 apply.
5 Test organism
5.1 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganism of demonstrated equivalent performance as required by this document.
NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus.
NOTE 2 Geobacillus stearothermophilus ATCC 7953 (NCTC 1 0007, DSM 22 and CIP 52.81 ),
ATCC 1 2980 (equivalent to NRRL B-441 9) have been found to be suitable 1
[1 ][2] .
5.2 If a test organism other than Geobacillus stearothermophilus or Bacillus subtilis ATCC 35021 (5230) is used,the suitability of the resistance of that test organism shall be determined.
NOTE For processes at less than 1 21 °C, microorganisms such as Bacillus subtilis ATCC 35021 (5230) could be used, particularly in sterilization of heat-sensitive liquids.
6 Suspension
The requirements of ISO 1 11 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 moist heat sterilization processes shall be demonstrated in accordance with the requirements of ISO 1 1 1 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 5 °C above the manufacturer’s stated maximum exposure temperature,
b) sterilizing agent: dry saturated steam; if the biological indicator is intended for use in a moist heat process not using dry saturated steam, e.g. an air/steam mixture, the appropriate air steam mixture should be used and noted as an exception to this document,
c) maximum exposure temperature: as stated by the manufacturer; if not stated by the manufacturer, a temperature of 1 40 °C shall be used, and
d) exposure time: greater than or equal to 30 min.
NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a moist heat sterilization process.
9.4 The resistance shall be expressed as the D value in minutes at 1 21 °C. Additional temperature(s) may be selected by the manufacturer. The D value of each batch/lot of biological indicators or inoculated carriers shall be stated in minutes to one decimal place at 1 21 °C.
9.5 Suspensions, inoculated carriers or biological indicators containing Geobacillus stearothermophilus spores shall have a D 121 value of greater than or equal to 1 ,5 min when tested according to the conditions given in Annex A. Other microorganisms shall have D values supporting the application. The z value of the test organisms in the suspension, on the inoculated carrier or in the biological indicator shall be determined at not less than three temperatures, in the range of 1 1 0 °C to 1 38 °C. These data shall be used to calculate the z value, which shall be greater than or equal to 6 °C (see Annex B).
9.6 The resistance characteristics specified in this document and any other part of ISO 1 1 138 shall be defined using the specific critical variables associated with the referenced sterilization process.
