Kemikalier för desinficering inom hushåll och industri

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 16 okt 2018
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The method described is designed to determine the disinfectant activity of processes used in the 1) human health, 2) veterinary, 3) food, industrial and institutional sectors using chemical processes.

The objective of the described processes is to disinfect the surfaces of the overall area including the external surfaces of the equipment contained in such rooms. Air handling and products or processes specifically designed for the disinfection of medical devices are excluded from the scope of this document.

The test methods and volumes described provide the defined challenge. Even if an automated airborne disinfection system has passed all or part of the test described here, the system and its delivered cycles should then be validated in the individual enclosure to be disinfected using appropriate biological or chemical indicators.

This document describes a Phase 2 step 2 methods designed:

— to check, under standardized laboratory conditions approaching real-world practice, that the proposed airborne surface disinfection processes meet the objective for which they were devised;

— to cross-compare the different processes under reproducible conditions;

— to provide an experimental design within specified boundaries when real-world-practice conditions depart from the conditions given in the text below.

The method is applicable to processes to be used in the area of human medicine, the veterinary area and in food, industrial, domestic and institutional areas (WG1, WG2 and WG3).

It applies to the process of whole enclosure / room disinfection achieved by automated processes (i.e. with no operator manually applying the disinfectant). This document covers the disinfection of nonporous surfaces but not that of air;

This method can be used as a basis for biosecurity applications in laboratories.

The method is used to qualify the process, i.e. the set of components and consumables needed for implementation. By way of example, for chemical processes, the device product combination cannot be separated.

This document is applicable to processes for which activity is claimed against the following categories of microorganisms:

— vegetative bacteria including mycobacteria,

— bacterial spores,

— yeasts,

— fungal spores and,

— viruses.

Each activity can be claimed independently but passing both bactericidal and yeasticidal activity as per text in Annex A tests is the minimum requirement to claim compliance.

An activity tested for each domain of application may only be claimed if the criteria are achieved against all of the specified organisms associated with that activity.

The proposed method includes 2 parts:

— Part 1 - Efficacy test: intended to ensure that minimal efficacy requirements are obtained for each type of activity claimed and for the targeted application(s) (WG1 and/or WG2 and/or WG3).

— Part 2 - Distribution test: intended to ensure efficacy of the process throughout the enclosure. It is performed with a reference microorganism at 4 sampling positions.

The tests described in this document are based on measuring the logarithmic reduction of different species of bacteria, yeasts, moulds, bacterial spores, bacteriophages or viruses and mycobacteria under a specified set of conditions. As the panel of microorganisms selected may prove to be too narrow for certain applications, it may be supplemented by other strains based on the experimental design described in this document, by varying the conditions according to the needs of the practical application(s) envisaged.

For the defined test conditions the number of test position of the carriers can be increased according to specific needs of a given application or local requirements.

The manufacturer:

— specifies the limitations for use and precautions for use of the process;

— ensures that the documented test conditions are representative of the recommended practice(s).

The aim of this document is to simulate practical conditions of airborne disinfection in a laboratory situation; obligatory conditions are defined according to the method defined below. Additional conditions are also proposed.

The test report specifies and summarizes the conditions under which the tests are carried out.

The processes are generally implemented after a cleaning procedure and are then tested, according to the application sectors, under clean or low-level soiling conditions. For some specific applications, and according to the manufacturer's recommendations, evaluation methods in the presence of other interfering substances can also be envisaged under additional conditions.