Kommittébeteckning: SIS/TK 410 (Hydrogenteknik)
Källa: ISO
Svarsdatum: den 17 aug 2018
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This International Standard specifies the minimum quality characteristics of hydrogen fuel as distributed for utilization in vehicular and stationary applications.

It is applicable to hydrogen fuelling applications, which are listed in Table 1 of this International Standard.

Ämnesområden: Djurfoder; Kemisk analys
Kommittébeteckning: SIS/TK 435 (Livsmedel och foder)
Källa: CEN
Svarsdatum: den 13 sep 2018
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This document describes a method for the determination of individual ergot alkaloids and tropane alkaloids in unprocessed cereals and cereal-based compound feeds by high performance liquid chromatography with tandem mass spectrometry (LC-MS/MS).

This method has been successfully validated by collaborative trial in the following matrices: rye, barley, wheat, complete feed for bovine, porcine and poultry. Validation in buckwheat produced acceptable results, but the relative standard reproducibility was higher for most analytes in comparison with the other matrices. This may be related to the matrix. The validated range of the method is approximately 10 μg/kg to 250 μg/kg for individual alkaloids. Determination of concentrations above 250 μg/kg is possible by applying a higher spiking level and dilution of the sample extract, but this has not been validated in the collaborative trial.

The method is applicable for the determination, by means of one-point standard addition to the sample, of ergocornine in the tested range of 12 μg/kg to 221 μg/kg, ergocorninine in the tested range of 9 μg/kg to 196 μg/kg, ergocristine in the tested range of 14 μg/kg to 312 μg/kg, ergocristinine in the tested range of 12 μg/kg to 258 μg/kg, α-ergocryptine in the tested range of 10 μg/kg to 184 μg/kg, α-ergocryptinine in the tested range of 8 μg/kg to 171 μg/kg, ergometrine in the tested range of 12 μg/kg to 174 μg/kg, ergometrinine in the tested range of 3 μg/kg to 172 μg/kg, ergosine in the tested range of 12 μg/kg to 226 μg/kg, ergosinine in the tested range of 9 μg/kg to 273 μg/kg, ergotamine in the tested range of 11 μg/kg to 443 μg/kg, ergotaminine in the tested range of 10 μg/kg to 273 μg/kg, atropine in the tested range of 16 μg/kg to 252 μg/kg and scopolamine in the tested range of 15 μg/kg to 246 μg/kg.

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.