ANSI AAMI 11138-5-2017 pdf download.
ANSI AAMI ID54-1996 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 low-temperature steam and formaldehyde as the sterilizing agent.
NOTE 1 Requirements for validation and control of low-temperature steam and formaldehyde sterilization processes are provided by ISO 1 4937.
NOTE 2 Requirements for work place safety can be provided by national or regional regulations.
1 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
2 Terms and definitions
For the purposes of this document, the terms and definitions given in ISO 1 1 1 38-1 and the following 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/
3.1 low-temperature steam and formaldehyde sterilization
process incorporating forced air removal, which allows exposure of wrapped goods to steam at sub-atmospheric pressure, and thus at temperatures less than 100 °C, with the admission of formaldehyde gas, keeping the sterilizing agent in a steady state throughout the hold time
4 Test organism
5.1 The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganisms of
demonstrated equivalent performance as required by this document.
NOTE 1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus.
NOTE 2 Geobacillus stearothermophilus NCIB 8224, DSM 6790, ATCC 7953, ATCC 1 01 49 and
ATCC 1 2980 have been found to be suitable 1 .
5.2 If a test organism other than Geobacillus stearothermophilus is used, the suitability of the resistance of that
test organism shall be determined.
5 Suspension
The requirements of ISO 1 11 38-1 apply.
6 Carrier and primary packaging
7.1 The suitability of the carrier and primary packaging materials for biological indicators for use in low-temperature steam and formaldehyde sterilization processes shall be demonstrated in accordance with the requirements of ISO 11 1 38-1 :201 7, 5.2 and Annex B.
NOTE Carriers based on filter paper might not be suitable because of the chemisorption of
formaldehyde on cellulose surfaces.
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 exposure temperature;
b) 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 00 °C;
c) exposure time: greater than or equal to 1 60 min.
NOTE These conditions have been selected to represent a realistic challenge to the carrier while remaining within the practical limits of a low-temperature steam and formaldehyde sterilization process.
7 Inoculated carriers and biological indicators
The requirements of ISO 1 11 38-1 apply.
8 Population and resistance
9.1 The resistance characteristics shall be stated according to ISO 1 1 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 5 .
9.4 The resistance shall be expressed as the D value in mins at 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 60 °C.
9.5 Suspensions, inoculated carriers or biological indicators containing Geobacillus stearothermophilus spores shall have a D 60 value of greater than or equal to 6 min when tested according to the conditions in Annex A. Other microorganisms shall have D values supporting the application.
9.6 The resistance characteristics specified in this document and any other part of ISO 1 1 1 38 shall be defined using the specific critical variables associated with the referenced sterilization process.
