ANSI AAMI 11138-5-2017 pdf free download – Sterilization of health care products—Biological indicators—Part 5: Biological indicators for low-temperature steam and formaldehyde sterilization processes.
This document specifies requirements for test organisms, suspensions, inoculated carriers, biological indicators andtest methods intended for use in assessing the performance of sterlization processes employing low-temperaturesteam and formaldehyde as the sterilizing agent.
NOTE1 Requirements for validation and control of low-temperature steam and formaldehydesterilization processes are provided by ISO 14937.
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 constitutesrequirements of this document. For dated references, only the edition cited applies.For undated references, the latestedition of the referenced document (including any amendments) applies.
ISO 11138-1:2017, Sterilization of health care products—Biological indicators—Part 1 : General requirementsTerms and definitions
For the purposes of this document, the terms and definitions given in ISO 11138-1 and the following apply.lISO and lEC 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/obpl
3.1
low-temperature steam and formaldehyde sterilization
process incorporating forced air removal, which allows exposure of wrapped goods to steam at sub-atmosphericpressure, and thus at temperatures less than 100 C, with the admission of formaldehyde gas, keeping the sterilizingagent in a steady state throughout the hold time
3 General requirements
The requirements of lSO 11138-1 apply.
4Test organism
5.1The test organisms shall be spores of Geobacillus stearothermophilus or other strains of microorganisms ofdemonstrated equivalent performance as required by this document.
NOTE1 Bacillus stearothermophilus has been reclassified as Geobacillus stearothermophilus.
NOTE2 Geobacillus stearothermophilus NCIB 8224，DSM 6790，ATCC 7953,ATCC 10149 andATCC 12980 have been found to be suitable1.
5.2lf a test organism other than Geobacillus stearothermophilus is used, the suitability of the resistance of thattest organism shall be determined.
5 suspension
The requirements of ISO 11138-1 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 sterlization processes shall be demonstrated in accordance with therequirements of lSO 11138-1:2017,5.2 and Annex B.
NOTE Carriers based on filter paper might not be suitable because of the chemisorption offormaldehyde on cellulose surfaces.
7.2The 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 100 °C;
)exposure time: greater than or equal to 160 min.
NOTE These conditions have been selected to represent a realistic challenge to the carrier whileremaining within the practical limits of a low-temperature steam and formaldehyde sterilization process.7 lnoculated carriers and biological indicators
The requirements of lSO 11138-1 apply.
8Population and resistance
9.1The resistance characteristics shall be stated according to ISO 11138-1:2017,6.4.
9.2The viable count shall be stated with increments less than or equal to 0,1 x 10” per unit (e.g. per ml ofsuspension, per inoculated carrier or per biological indicator).ANSI AAMI 11138-5 pdf download.