ISO 21148-2017 PDF
Name in English:
St ISO 21148-2017
Name in Russian:
Ст ISO 21148-2017
Original standard ISO 21148-2017 in PDF full version. Additional info + preview on request
Full title and description
ISO 21148:2017 — Cosmetics — Microbiology — General instructions for microbiological examination. Provides general instructions and a risk-based framework for performing microbiological examinations of finished cosmetic products to help ensure product quality and consumer safety.
Abstract
Gives general instructions for carrying out microbiological examinations of cosmetic products, aligned with an appropriate microbiological risk analysis (for example: products with low water activity, hydro‑alcoholic formulations, extreme pH values). Notes that because of the wide variety of cosmetic formulations and applications, the instructions may need adaptation for some products (e.g., certain water‑immiscible products).
General information
- Status: Published (International Standard, confirmed).
- Publication date: 2017 (published June 2017 / valid from 29 May 2017 in some listings).
- Publisher: International Organization for Standardization (ISO), developed by ISO/TC 217 (Cosmetics).
- ICS / categories: 07.100.40 (Cosmetics microbiology) / 71.100.70 (Cosmetics, toiletries).
- Edition / version: Edition 2 (ISO 21148:2017).
- Number of pages: 21 (ISO published PDF) — note: national/adopted versions (EN/BS/UNE, etc.) may show different page counts (commonly 30–32 pages).
Scope
Applies to the microbiological examination of finished cosmetic products and gives general instructions applicable across a broad range of product types. The standard is intended to support laboratory practice and decision making (including sampling, handling, and interpretation) in the context of an appropriate product‑specific risk assessment. It explicitly recognizes that some product categories (for example, water‑immiscible or otherwise atypical formulations) may require modified or alternative methods.
Key topics and requirements
- Risk‑based approach to determine when and how to perform microbiological examinations.
- General instructions on sampling, sample preparation and neutralization when antimicrobial agents are present.
- Guidance on selection of suitable detection/enumeration methods and interpretation of results in context of product characteristics.
- Notes on limitations for certain product types (e.g., water‑immiscible products) and the need for method adaptation or validation.
- Emphasis on documentation, laboratory best practice and linkage to specific test standards for organisms or methods.
Typical use and users
Used by cosmetics manufacturers, quality control and R&D laboratories, contract testing laboratories, regulatory bodies, and auditors implementing or assessing microbiological testing programs. Useful when establishing test plans, interpreting microbiological findings, and integrating results with preservative‑efficacy testing and risk assessments.
Related standards
Commonly referenced/paired standards within cosmetics microbiology and GMP frameworks include ISO 21149 (enumeration and detection of aerobic mesophilic bacteria), ISO 21150 (detection of Escherichia coli), ISO 29621 (guidelines for risk assessment and identification of microbiologically low‑risk products), ISO 11930 (preservative efficacy / evaluation of antimicrobial protection), ISO 18415 (detection/identification of specified and non‑specified microorganisms), and ISO 22716 (cosmetics — Good Manufacturing Practices). These documents are often used together to define specific tests, interpret results and establish control strategies.
Keywords
cosmetics; microbiology; microbial examination; risk assessment; sampling; sample preparation; preservative efficacy; quality control; ISO/TC 217.
FAQ
Q: What is this standard?
A: ISO 21148:2017 is an international standard that provides general instructions for performing microbiological examinations of finished cosmetic products, emphasizing a risk‑based approach to ensure product quality and safety.
Q: What does it cover?
A: It covers general laboratory instructions, sampling and sample preparation considerations, guidance on selecting appropriate detection/enumeration methods, interpretation of results in the context of product risk, and notes on method limitations for certain product types.
Q: Who typically uses it?
A: Cosmetics manufacturers, QC and R&D laboratories, contract testing labs, regulatory authorities, and auditors responsible for microbiological control of cosmetic products.
Q: Is it current or superseded?
A: ISO 21148:2017 is the second edition (published 2017) and is listed as a published/confirmed International Standard. ISO standards are reviewed periodically (typically every five years) and users should check national or ISO catalogues for any later amendments or revisions.
Q: Is it part of a series?
A: Yes — it forms part of the ISO cosmetics‑microbiology suite developed by ISO/TC 217 and is typically used alongside related documents such as ISO 21149, ISO 21150, ISO 29621, ISO 11930, ISO 18415 and ISO 22716 to build a complete microbiological testing and risk‑management program.
Q: What are the key keywords?
A: Cosmetics, microbiology, microbial testing, sampling, risk assessment, preservative efficacy, quality control, ISO 21148.