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AAMI 18472 2022

AAMI 18472 2022

$143.79

ANSI/AAMI/ISO 18472:2022, Sterilization of health care products—Biological and chemical indicators—Test equipment

Published By Publication Date Number of Pages
AAMI 2022 41
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Specifies requirements for test equipment to be used to test biological indicators for steam, ethylene oxide gas and dry heat sterilization processes for conformity to the requirements given in ISO 11138 series and test chemical indicators for steam, ethylene oxide gas, dry heat and vaporized hydrogen peroxide sterilization processes for conformity to the requirements given in ISO 11140-1:2014.

PDF Catalog

PDF Pages PDF Title
1 ANSI/AAMI/ISO 18472:2022; Sterilization of health care products—Biological and chemical indicators—Test equipment
3 Title page
4 AAMI Standard
Copyright information
5 Contents Page
7 Committee representation
10 Background of ANSI/AAMI adoption of ISO 18472:2018
11 Foreword
12 Introduction
13 1 Scope
2 Normative references
14 3 Terms and definitions
16 4 Performance requirements for resistometers
4.1 Intended use
4.2 Test methods
4.3 Air leakage test
17 4.4 Steam resistometer performance requirements
4.4.1 Measurement accuracy
Table 1—Steam resistometer instrumentation requirements (measurement and recording)
4.4.2 Data
4.4.3 Process control
18 Table 2—Steam resistometer physical conditions
Figure 1—Stabilization time for temperature for steam resistometer
19 4.4.4 General steam resistometer requirements
4.4.5 Air leakage test
4.4.6 Operation of steam resistometer
4.5 Ethylene oxide gas resistometer performance requirements
4.5.1 Measurement accuracy
20 Table 3—EO gas resistometer instrumentation requirements (measurement and recording)
4.5.2 Data
4.5.3 Process control
21 Table 4—EO gas resistometer physical design/control specifications
Figure 2—Stabilization time for temperature for ethylene oxide gas resistometer
22 4.5.4 General ethylene oxide gas resistometer requirements
4.5.5 Air leakage test
4.5.6 Operation of ethylene oxide gas resistometer
4.5.6.1 The chamber shall be designed such that the formation of condensate during any stage of the operating cycle does not adversely affect the required test conditions. In order to avoid condensation during the operating cycle it might be necessary…
4.5.6.2 Before initiating a test cycle, the inner surface of the chamber shall be heated to the test temperature.
4.5.6.3 The equipment shall be provided with a means of evacuating the chamber to less than the vacuum set point to permit adequate air removal prior to admission of water vapour and ethylene oxide gas.
4.5.6.4 Data from controlled values shall be provided at an interface to record with a minimum frequency of 1 s.
4.6 Dry heat (heated air) resistometer performance requirements
4.6.1 Measurement accuracy
23 Table 5—Dry heat resistometer instrumentation requirements (measurement and recording)
4.6.2 Data
4.6.3 Process control
Table 6—Dry heat resistometer physical design/control specifications
24 4.6.4 General dry heat (heated air) resistometer requirements
4.6.5 Operation of dry heat (heated air) resistometer
4.7 Vaporized hydrogen peroxide resistometer performance requirements
4.7.1 Measurement accuracy
25 Table 7—Vaporized hydrogen peroxide resistometer instrumentation requirements (measurement and recording)
4.7.2 Recording interval
4.7.3 Process control
27 4.7.4 General vaporized hydrogen peroxide resistometer requirements
4.7.5 Air leakage test
4.7.6 Operation of vaporized hydrogen peroxide resistometer
5 Calibration
28 Annex A (informative) Additional performance characterization—Steam
A.1 General
Figure A.1—Steam test sequence
29 A.2 Chamber air removal
A.3 Vacuum/pressurization rate
A.4 Range characterization
A.5 Indicator orientation
30 Annex B (informative) Additional performance characterization—Ethylene oxide gas
B.1 General
Figure B.1—Sequence of ethylene oxide gas resistometer used in ethylene oxide gas exposure processes
31 B.2 Chamber air removal
B.3 Vacuum/pressurization rate
B.4 Range characterization
32 Annex C (informative) Additional performance characterization—Dry heat
C.1 General
C.2 Specific variable response
C.3 Range characterization
33 Figure C.1—Sequence of dry heat resistometer used in dry heat exposure processes
34 Annex D (informative) Resistometer documentation and derivations
D.1 General
D.2 Calculation of relative humidity concentration
35 D.3 Calculation of ethylene oxide gas concentration
D.3.1 General
36 D.3.2 Calculations
37 Table D.1—EO gas/diluent constants, K
Table D.2—Molecular mass
D.3.3 Example calculations/Determining ethylene oxide gas concentration
38 D.3.4 Derivation of Formula (D.4)
39 Table D.3—Gas constants, R
D.4 Documentation
D.4.1 General
D.4.2 Minimum information
40 Bibliography

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AAMI 18472 2022
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