ISO 21322:2020
Cosmetics — Microbiology — Testing of impregnated or coated wipes and masks
This document gives guidance for the enumeration and/or detection of microorganisms present in a cosmetic product that is impregnated or coated onto a substrate (i.e. wipes and masks) where sampling and microbiological influence of the manufactured product presents particular challenges in terms of microbiological sampling and testing.
The principle of this document can also be applied to test similar products (e.g. cushion, impregnated sponge, etc.) or applicators (e.g. brush, puff, sponge, etc.) with modification of the procedure as appropriate.
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
4.1 General information
4.2 Selection of the test sample
4.3 Selection of the method
4.4 Recovery of microorganisms from the test sample
4.5 Enumeration of aerobic mesophilic microorganisms
4.5.1 General
4.5.2 Plate count method overview
4.5.3 Membrane filtration method overview
4.6 Detection of specified microorganisms by enrichment method
5 Diluents, neutralizers and culture media
5.1 General
5.2 Diluents and neutralizers
5.3 Culture media
5.3.1 Media for enumeration and detection
5.3.2 Media for preparation of spores of Bacillus subtilis
6 Apparatus and glassware
7 Strains of microorganisms
8 Handling of cosmetic products and laboratory samples
9 Procedure
9.1 General recommendation
9.2 Selection and preparation of the test sample
9.2.1 Selection of the test sample
9.2.2 Preparation of the initial suspension
9.3 Recovery of microorganisms
9.3.1 General
9.3.2 Stomaching
9.3.3 Shaking/Stirring
9.4 Enumeration of aerobic mesophilic microorganisms
9.4.1 General
9.4.2 Pour plate method
9.4.3 Surface spread method
9.4.4 Membrane filtration method
9.4.5 Incubation
9.4.6 Counting of colonies
9.5 Detection of specified microorganisms by enrichment method
9.5.1 General
9.5.2 Test for specified microorganisms
10 Expression of results
10.1 Enumeration of aerobic mesophilic microorganisms
10.2 Detection of specified microorganisms
11 Suitability test
12 Test report
Annex A (normative) Guidance on methods for microbiological testing of impregnated or coated products — Wipes and masks
Annex B (informative) Expression and interpretation of results
Annex C (normative) Suitability test method
Bibliography
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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Principle
4.1 General information
4.2 Selection of the test sample
4.3 Selection of the method
4.4 Recovery of microorganisms from the test sample
4.5 Enumeration of aerobic mesophilic microorganisms
4.5.1 General
4.5.2 Plate count method overview
4.5.3 Membrane filtration method overview
4.6 Detection of specified microorganisms by enrichment method
5 Diluents, neutralizers and culture media
5.1 General
5.2 Diluents and neutralizers
5.3 Culture media
5.3.1 Media for enumeration and detection
5.3.2 Media for preparation of spores of Bacillus subtilis
6 Apparatus and glassware
7 Strains of microorganisms
8 Handling of cosmetic products and laboratory samples
9 Procedure
9.1 General recommendation
9.2 Selection and preparation of the test sample
9.2.1 Selection of the test sample
9.2.2 Preparation of the initial suspension
9.3 Recovery of microorganisms
9.3.1 General
9.3.2 Stomaching
9.3.3 Shaking/Stirring
9.4 Enumeration of aerobic mesophilic microorganisms
9.4.1 General
9.4.2 Pour plate method
9.4.3 Surface spread method
9.4.4 Membrane filtration method
9.4.5 Incubation
9.4.6 Counting of colonies
9.5 Detection of specified microorganisms by enrichment method
9.5.1 General
9.5.2 Test for specified microorganisms
10 Expression of results
10.1 Enumeration of aerobic mesophilic microorganisms
10.2 Detection of specified microorganisms
11 Suitability test
12 Test report
Annex A (normative) Guidance on methods for microbiological testing of impregnated or coated products — Wipes and masks
Annex B (informative) Expression and interpretation of results
Annex C (normative) Suitability test method
Bibliography