ANSI AAMI 11138-4-2017 pdf download.
ANSI AAMI 11138-4-2017 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 dry heat as the sterilizing agent at sterilizing temperatures within the range of 1 20 °C to 1 80 °C.
NOTE 1 Requirements for validation and control of dry heat sterilization processes are provided by ISO 20857.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
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 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 CIP 77.1 8, NCIMB 8058, DSM 675, NRRL B-441 8 and ATCC 9372 or Bacillus subtilis, DSM 1 301 9 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 dry heat sterilization processes shall be demonstrated in accordance with the requirements of ISO 11 1 38-1:201 7, 5.2 and Annex B.
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 temperature;
b) sterilizing agent: dry heat in ambient air;
c) 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 80 °C;
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 dry heat 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 according to ISO 11 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 6 .
9.4 The resistance shall be expressed as the D value in minute at 1 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 160 °C.
