ISO 12787-2011 PDF
Name in English:
St ISO 12787-2011
Name in Russian:
Ст ISO 12787-2011
Original standard ISO 12787-2011 in PDF full version. Additional info + preview on request
Full title and description
ISO 12787:2011 — Cosmetics — Analytical methods — Validation criteria for analytical results using chromatographic techniques. This International Standard defines validation criteria and an analytical approach for chromatographic analyses of cosmetic products to ensure performance, reliability and quality of analytical results.
Abstract
ISO 12787:2011 specifies validation criteria that analytical results from the analysis of cosmetic products should meet when chromatographic techniques are used. It provides guidance suitable for use by a single laboratory to validate and report chromatographic analyses on one or more samples, focusing on criteria that give confidence in final results.
General information
- Status: Published (International Standard; confirmed lifecycle review completed).
- Publication date: 13 December 2011.
- Publisher: International Organization for Standardization (ISO).
- ICS / categories: 71.100.70 (Cosmetics, toiletries).
- Edition / version: Edition 1 (2011).
- Number of pages: 16.
Summary metadata above is taken from the ISO bibliographic record for ISO 12787:2011.
Scope
ISO 12787:2011 defines validation criteria for analytical results obtained from chromatographic analysis of cosmetic products. The standard sets out an analytical approach that can be applied by a single laboratory to carry out and validate chromatographic analyses on given sample(s), addressing the assessment of performance, reliability and quality of results produced by chromatographic methods.
Key topics and requirements
- Validation criteria for chromatographic analytical results (performance characteristics and acceptance criteria).
- Parameters typically covered: accuracy (trueness), precision (repeatability/reproducibility), limits of detection and quantification, linearity and range, specificity/selectivity, and system suitability checks.
- Guidance on calibration, control samples and use of reference materials where applicable.
- Requirements for documentation, reporting of results and assessment of measurement uncertainty relevant to cosmetic analyses.
- Applicability to a laboratory performing chromatographic analyses on cosmetic samples (method validation/verification workflow emphasis).
These topics reflect the standard’s emphasis on method validation/acceptance criteria for chromatographic techniques applied to cosmetics.
Typical use and users
Primary users are analytical laboratories (in-house and third‑party) performing chromatographic testing of cosmetic products, quality control and R&D teams within cosmetic manufacturers, regulatory and conformity assessment bodies reviewing analytical evidence, and method developers who need validated chromatographic procedures for cosmetics testing. Laboratories seeking accreditation for cosmetic testing often use this standard alongside laboratory competence standards.
Related standards
Standards commonly referenced alongside ISO 12787:2011 include ISO 22716 (Good Manufacturing Practices — guidelines for production, control, storage and shipment of cosmetic products) and ISO/IEC 17025 (general requirements for the competence of testing and calibration laboratories). ISO 12787 is produced under the technical committee for cosmetics (ISO/TC 217) and is intended to be used in the broader context of cosmetic quality and laboratory competence frameworks.
Keywords
cosmetics; chromatographic techniques; analytical methods; method validation; validation criteria; quality control; limits of detection; accuracy; precision; measurement uncertainty; ISO/TC 217.
FAQ
Q: What is this standard?
A: ISO 12787:2011 is an ISO International Standard that provides validation criteria and an analytical approach for chromatographic methods used to generate analytical results for cosmetic products.
Q: What does it cover?
A: It covers validation criteria (performance characteristics and acceptance criteria) and procedural guidance for chromatographic analyses of cosmetics, including aspects such as accuracy, precision, detection/quantification limits, specificity, calibration and documentation of results.
Q: Who typically uses it?
A: Analytical testing laboratories, cosmetic manufacturers’ QC and R&D teams, regulators and accreditation bodies, and method developers involved in chromatographic analysis of cosmetic products.
Q: Is it current or superseded?
A: ISO 12787:2011 was published on 13 December 2011. The ISO bibliographic record indicates the standard was reviewed and its status confirmed in a later periodic review (confirmed as current in the ISO record). Users should check the issuing body for any amendments or a newer edition before purchase or formal adoption.
Q: Is it part of a series?
A: It is a standalone International Standard developed under ISO/TC 217 (Cosmetics). While not a numbered multi‑part series, it is intended to be used in the broader family of cosmetic standards and laboratory competence standards (for example ISO 22716 and ISO/IEC 17025).
Q: What are the key keywords?
A: Cosmetics; chromatographic techniques; analytical validation; method validation; accuracy; precision; limits of detection; system suitability; measurement uncertainty.