ISO 21149:2017 化粧品—微生物学—好気性中温性細菌の数え上げと検出 | ページ 2

Foreword

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This document was prepared by Technical Committee ISO/TC 217, Cosmetics.

This second edition cancels and replaces the first edition (ISO 21149:2006), of which it constitutes a minor revision with the following changes:

• the Scope, “validated” has been changed to “shown to be suitable”;
• the Scope, “see ISO 29621” has been added and the reference has been added to the Bibliography;
• 4.1, “validated” has been changed to “demonstrated”;
• 4.3, “validated” has been changed to “described”;
• 5.1, “specifications” has been changed to “instructions”;
• 9.3.2.1, 9.3.2.2 and 9.3.2.3, “validated” has been changed to “described”;
• 9.3.2.3, “procedure developed during the validation” has been changed to “suitability test procedure”;
• 9.4.1, “validation” has been changed to “suitability test”;
• 12.2.1, “validated according to the chosen method” has been changed to “demonstrated to be suitable for the chosen method”;
• 13.3 and 13.4, “validation” has been changed to “suitability”;
• 13.3.2, 13.3.3 and 13.3.4, “validation” has been changed to “suitability”;
• 13.3.2, 13.3.3 and 13.3.4, “if the validation count is at least 50 % (0,3 log) of the control count" has been changed to “if the count is at least 50 % of the control”;
• 13.4.1, instances of “validation test” have been changed to “suitability test”;
• 13.4.2, instances of “validation plate” have been changed to “suitability test plate”;
• 13.5, “validation results” has been changed to “suitability test results” and “validation plates” has been changed to “suitability test plates”;
• Clause 14 f), “validation of the method” has been changed to “demonstration of the suitability”;
• A.1, B.1 and C.1, “validated” has been changed to “demonstrated to be suitable”.

1 Scope

This document gives general guidelines for enumeration and detection of aerobic mesophilic bacteria present in cosmetics

• by counting the colonies on agar medium after aerobic incubation, or
• by checking the absence of bacterial growth after enrichment.

Because of the large variety of cosmetic products within this field of application, this method may not be appropriate for some products in every detail (e.g. certain water immiscible products). Other methods (e.g. automated) may be substituted for the tests presented here provided that their equivalence has been demonstrated or the method has been otherwise shown to be suitable.

If needed, microorganisms enumerated or detected may be identified using suitable identification tests described in the standards given in the Bibliography.

In order to ensure product quality and safety for consumers, it is advisable to perform an appropriate microbiological risk analysis to determine the types of cosmetic products to which this document is applicable. Products considered to present a low microbiological risk (see ISO 29621) include those with low water activity, hydro-alcoholic products, extreme pH values, etc.

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.

3 Terms and definitions

For the purposes of this document, the following terms and definitions apply.

ISO and IEC maintain terminological databases for use in standardization at the following addresses:

Bibliography