ISO 7581:2023
Evaluation of bactericidal activity of a non-porous antimicrobial surface used in a dry environment
Evaluation of bactericidal activity of a non-porous antimicrobial surface used in a dry environment
- Статус документа:
- Действующий
- Формат:
- Электронный (PDF)
- Количество страниц:
- 24
- Дата публикации:
- 6 декабря 2023 г.
- Издание:
- ISO IS 7581 edition 1 version 1
- ICS:
- 07.100.99
This document specifies the test conditions and the levels of activity to determine the bactericidal activity of non-porous surfaces used in a dry environment. It defines a protocol to validate the bactericidal character of a surface and to measure its performance. It is not intended to be used to substantiate cleaning or disinfecting properties. This document is applicable to surfaces claiming to have an activity against vegetative bacteria. The obligatory test conditions are defined in this document. It does not apply to porous surfaces. It does not refer to methods for testing the toxicological and ecotoxicological properties of the surfaces. This document is used to measure bactericidal action, not bacteriostatic activity of a surface.
Abstract
Overview
ISO 7581:2023 – Evaluation of bactericidal activity of a non‑porous antimicrobial surface used in a dry environment describes a standardized laboratory protocol to measure bactericidal activity of non‑porous surfaces in dry conditions. The standard specifies obligatory test conditions, sampling and test procedures, and how to express results for surfaces claiming activity against vegetative bacteria. It is focused on validating bactericidal action (killing) - not bacteriostatic (growth inhibition) - and is not intended to substantiate cleaning/disinfecting claims or to assess toxicological/ecotoxicological properties.
Key Topics and Technical Requirements
- Scope and limits: Applicable only to non‑porous surfaces in dry environments; porous materials are excluded. Tests simulate contamination by microdroplets (e.g., post‑sneeze scenarios) under ambient conditions representative of healthcare settings.
- Test organisms and strains: The document prescribes representative bacterial strains (see Annex A) and allows additional strains depending on intended use.
- Obligatory experimental conditions: Defined temperatures, humidity ranges, contact times and other mandatory parameters to ensure comparable, reproducible results.
- Test surfaces and references: Defines requirements for test surfaces and reference surfaces and their preparation (see Annex C).
- Procedure elements: Preparation of bacterial suspensions, inoculum deposition, sampling (T, C and validation Vn samples), neutralization strategies (Annex D), and colony quantification.
- Results and interpretation: Methods to calculate reductions in viable bacteria and criteria for concluding bactericidal activity (reduction metrics, verification and reporting).
- Supporting guidance: Informative annexes include a standard test report (Annex B), surface preparation examples, neutralizers, and technical guidance on depositing the inoculum (Annexes C–E).
Practical Applications and Who Uses This Standard
ISO 7581:2023 is intended for:
- Manufacturers of antimicrobial coatings, treated materials, and intrinsically bactericidal metals who need to validate product claims.
- Independent testing laboratories performing conformity and performance testing.
- Regulatory and procurement bodies in healthcare, transport, food processing and public facilities evaluating antimicrobial surface performance.
- R&D teams developing surface treatments, coatings or materials with bactericidal claims.
Practical uses include product validation, comparative performance testing, supporting marketing claims for bactericidal action (subject to regulatory requirements), and informing compatibility testing with routine cleaning/disinfection practices.
Related Standards (if applicable)
- EN 12353 (referenced normative document) - preservation of test organisms used for activity testing.
- Other ISO and sector‑specific standards on disinfectants, surface testing and antimicrobial claims may complement ISO 7581:2023 for comprehensive conformity and safety assessment.
Технические детали
- Технический комитет
- ISO/TC 330 - Surfaces with biocidal and antimicrobial properties
- SKU
- ISO 7581:2023
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