Pregled nacrta

Odbor: HZN/TO 28 (Naftni proizvodi i maziva)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document specifies requirements and test methods for marketed and delivered automotive diesel fuel. It is applicable to automotive diesel fuel for use in diesel engine vehicles designed to run on automotive diesel fuel containing up to 7,0 %(V/V) Fatty Acid Methyl Ester (FAME).
NOTE For the purposes of this document, the terms "% (m/m)" and "% (V/V)" are used to represent respectively the mass fraction and the volume fraction.
Odbor: HZN/TO 218 (Drvo)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document specifies a method for determining the leaching of active ingredients or other compounds from preservative treated wood by a semi-field method for Use Class 3 (outdoor above ground). The preservative treated wood can be tested with or without subsequently surface coating or other water-repellent treatment. The method is applicable to the testing of commercial or experimental preservatives or paint systems applied to timber by methods appropriate to commercial practice.

Odbor: HZN/TO 44 (Zavarivanje i srodni postupci)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document specifies how a preliminary welding procedure specification (pWPS) for hyperbaric wet welding is qualified by welding procedure tests.

Odbor: HZN/TO 550 (Opskrba vodom)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document contains requirements for dosing systems for chlorine dioxide generation according to the chlorite-chlorine gas process, the chlorite-acid process and the chlorite-sodium peroxodisulphate process, which are used for the disinfection and oxidation of substances in water.
The chlorine dioxide (ClO2) solution is produced on site (in situ) by automated mixing of chemical precursors. This document applies to the treatment of water for human consumption, rinsing water for filters for swimming and bathing pools as well as for other uses (e.g. cooling water, process water, etc.

Odbor: HZN/TO 555 (Medicinski proizvodi)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document addresses good clinical practice for the design, conduct, recording and reporting of clinical investigations carried out in human subjects to assess the clinical performance or effectiveness and safety of medical devices.
For post-market clinical investigations, the principles set forth in this document are intended to be followed as far as relevant, considering the nature of the clinical investigation (see Annex I).
This document specifies general requirements intended to
— protect the rights, safety and well-being of human subjects,
— ensure the scientific conduct of the clinical investigation and the credibility of the clinical investigation results,
— define the responsibilities of the sponsor and principal investigator, and
— assist sponsors, investigators, ethics committees, regulatory authorities and other bodies involved in the conformity assessment of medical devices.
NOTE 1 Users of this document need to consider whether other standards and/or national requirements also apply to the investigational device(s) under consideration or the clinical investigation. If differences in requirements exist, the most stringent apply.
NOTE 2 For Software as a Medical Device (SaMD) demonstration of the analytical validity (the SaMD's output is accurate for a given input), and where appropriate, the scientific validity (the SaMD's output is associated to the intended clinical condition/physiological state), and clinical performance (the SaMD's output yields a clinically meaningful association to the target use) of the SaMD, the requirements of this document apply as far as relevant (see Reference [4]). Justifications for exemptions from this document can consider the uniqueness of indirect contact between subjects and the SaMD.
This document does not apply to in vitro diagnostic medical devices. However, there can be situations, dependent on the device and national or regional requirements, where users of this document might consider whether specific sections and/or requirements of this document could be applicable.

Odbor: HZN/TO 531 (Plastika i guma)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document establishes a system of designation for profiles made of unplasticized poly (vinyl chloride) (PVC-U) intended to be used for building applications.
This part is applicable to light coloured and coloured PVC-U profiles, obtained by a mono-extrusion or a co-extrusion process, with or without surface finishing (e.g. laminated foil, paint, printing process).
It specifies test methods and test parameters.
This method of designation is intended to be used in product specification when the application is specified.
Profiles for the management of electrical power cables, communication cables and power track systems used for the distribution of electrical power, profiles for windows or doors and profiles for guttering are not covered by this document .
NOTE It is intended to use this method for the designation of PVC-U profiles for information related to technical literature of the manufacturer, not for the marking of the products.
Odbor: HZN/TO 531 (Plastika i guma)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document establishes a system of designation for profiles made of cellular unplasticized poly(vinyl chloride) (PVC-UE) intended to be used for building applications.
This part is applicable to light coloured and coloured mono-extruded PVC-UE profiles, co-extruded profiles consisting of a core made of PVC-UE and a skin layer of non-cellular unplasticized poly(vinyl chloride) (PVC-U), and PVC-UE profiles with laminated foil or paint.
It specifies test methods and test parameters.
This method of designation is intended to be used in product specification when the application is specified.
Profiles for the management of electrical power cables, communication cables and power track systems used for the distribution of electrical power, profiles for windows or doors and profiles for guttering are not covered by this document .
NOTE It is intended to use this method for the designation of PVC-UE profiles for information related to technical literature of the manufacturer, not for the marking of the products.
Odbor: HZN/TO 528 (Oprema za željeznice)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document is applicable to vehicles operating on tram networks.
This document specifies all necessary design rules and associated assessment criteria as well as guidance concerning the design of information and the corresponding user interfaces of driver’s cabs of tram vehicles.
It considers the tasks the driver has to carry out and human factors. This document specifies how information is arranged and displayed.
All assessments based on the normative requirements of this document are applicable mainly to:
- symbols provided by Annex A;
- arrangement of screen areas conform with Figure 1 (generic organization of information);
- colours, fonts;
- audible information.
This document is applicable to the following aspects:
- legibility and intelligibility of displayed information: general rules concerning the layout of information on the displays, including character size and spacing;
- definition of harmonized colours, symbols, etc.;
- definition of harmonized principles for the command interface (by physical or touchscreen buttons): size, symbols, reaction time, way to give feedback to the driver, etc.;
- general arrangements (dialogue structures, sequences, layout philosophy, colour philosophy), symbols, audible information, data entry arrangements.
NOTE If this document deals with how information can be given for operation and in degraded situations, it does not define operating rules and degraded situations.
This document does not request any safety requirement related with displayed information.
This document specifies minimum requirements and does not prevent more complex solutions.
Requirements describing the functions using the display are out of scope of this document.
Odbor: HZN/TO 528 (Oprema za željeznice)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This European Standard specifies the interface requirements for controlled emission toilet equipment on railway vehicles and the infrastructure, including catering area sink waste retention tanks. Vehicle and infrastructure specific requirements are also given.
The European Standard includes fixed and portable infrastructure equipment used to empty retention tanks, but excludes equipment fitted to railway vehicles where no fixed connections are used between vehicle and infrastructure.

Odbor: HZN/TO 503 (Metalni materijali)
Ustanova izvornika:
Rok za komentiranje: 2024-08-12
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This document specifies the technical delivery requirements for bright steel products in the drawn, peeled/turned or additional ground condition and they are intended for mechanical purposes, for example for machine parts.

Odbor: HZN/TO 147 (Kvaliteta vode)
Ustanova izvornika:
Rok za komentiranje: 2024-08-13
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This document sets out key principles for the investigation of microplastics using thermo-analytical methods in water with low content of natural suspended solids.
This document gives requirements for the standardisation of methods towards harmonized procedures for determination of microplastics contents.

Odbor: HZN/TO 555 (Medicinski proizvodi)
Ustanova izvornika:
Rok za komentiranje: 2024-08-16
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This document specifies:
—          the general principles governing the biological evaluation of medical devices within a risk management process;
—          the general categorization of medical devices based on the nature and duration of their contact with the body;
—          the evaluation of existing relevant data from all sources;
—          the identification of gaps in the available data set on the basis of a risk analysis;
—          the identification of additional data sets necessary to analyse the biological safety of the medical device;
—          the assessment of the biological safety of the medical device.
This document applies to evaluation of materials and medical devices that are expected to have direct or indirect contact with: 
—          the patient's body during intended use;
—          the user's body, if the medical device is intended for protection (e.g., surgical gloves, masks and others). 
This document is applicable to biological evaluation of all types of medical devices including active, non-active, implantable and non-implantable medical devices.
This document also gives guidelines for the assessment of biological hazards arising from:
—          risks, such as changes to the medical device over time, as a part of the overall biological safety assessment;
—          breakage of a medical device or medical device component which exposes body tissue to new or novel materials. 
Other parts of ISO 10993 cover specific aspects of biological assessments and related tests. Device-specific or product standards address mechanical testing.
This document excludes hazards related to bacteria, moulds, yeasts, viruses, transmissible spongiform encephalopathy (TSE) agents and other pathogens.

Odbor: HZN/TO 557 (Zaštitna odjeća)
Ustanova izvornika:
Rok za komentiranje: 2024-08-18
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This document specifies a tomodynamometer cut test method and related calculations, for use on materials and assemblies designed for protective clothing, including gloves. The test determines resistance to cutting by sharp edges, such as knives, sheet metal parts, swarf, glass, bladed tools and castings.
When this document is cited as a test method in a material or product requirement standard, that standard contains the necessary information to permit the application of this document to the particular product.
This test does not provide data on the resistance to penetration by pointed objects such as needles and thorns, or the point of sharp-edged blades. The test described in this document is not considered suitable for testing materials made from chain mail and metal plates. The text of this document does not include provisions for the safeguard of the operator.

Odbor: HZN/TO 28 (Naftni proizvodi i maziva)
Ustanova izvornika:
Rok za komentiranje: 2024-08-19
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This document specifies requirements on petrol fuel for use as fuel in small engines, together with the methods to be applied for testing these properties.
This document specifies requirements for two types of petrol fuel having low aromatics and sulfur content: 
- one type for use in four-stroke engines with separate lubrication; and 
- one mixed petrol fuel type for use in mixture-lubricated engines.
Testing the properties of the added engine oil is out of the scope of this document.
NOTE For the purposes of this document, the terms “% (m/m)” and “% (V/V)” are used to represent respectively the mass fraction and the volume fraction.

Odbor: HZN/TU S1 (Zdravlje, okoliš i medicinska oprema 1)
Ustanova izvornika:
Rok za komentiranje: 2024-08-19
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This document applies to software for 2D x ray image analysis in dental medicine, the basis of which is the application of artificial intelligence (AI).
The scope of applicability of this document includes
a) Software-as-a-Medical Device (SaMD)
b) Software-in-a-Medical Device (SiMD) and
c) Software to improve the efficiency of healthcare applications.
This document applies to AI applications that learn statically and continuously/incrementally.

Odbor: HZN/TO 559 (Zaporni, regulacijski i sigurnosni uređaji)
Ustanova izvornika:
Rok za komentiranje: 2024-08-19
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This document specifies basic requirements for hydraulic part-turn valve actuators, both double acting and single acting, used for on-off and modulating control duties.
It includes guidelines, recommendations and methods for enclosure and corrosion protection, control and testing.
It does not apply to hydraulic actuators which are integral parts of control valves and to hydraulic actuators designed for permanent immersion in fresh or sea water as well as electro-hydraulic actuators.
Other requirements, or conditions of use, different from those indicated in this document can vary upon request.

Odbor: HZN/TO 146 (Kvaliteta zraka)
Ustanova izvornika:
Rok za komentiranje: 2024-08-19
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This document specifies the environmental conditions, the sample handling and analytical procedures and the method of calculating and presenting the results. Reasons are given for the need for more than one method and advice is given on the choice of method to be used.
This document establishes a categorization scheme for dustiness to provide a standardized way to express and communicate the results to users of the bulk materials. Details of the scheme for each method are given in EN 15051-2 and EN 15051-3.
This document is applicable to powdered, granular or pelletized bulk materials.
This document is not applicable to test the dust released during mechanical reduction of solid bulk materials (e.g. cut, crushed) or to test application procedures for the bulk materials.

Odbor: HZN/TO 146 (Kvaliteta zraka)
Ustanova izvornika:
Rok za komentiranje: 2024-08-19
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This document specifies the continuous drop test apparatus and associated test method for the reproducible production of dust from a bulk material under standard conditions, and the measurement of the inhalable and respirable dustiness mass fractions, with reference to existing documents, where relevant (see Clause 6).
This document specifies the continuous drop test apparatus and associated test method for the reproducible production of dust from a bulk material under standard conditions, and the measurement of the inhalable and respirable dustiness mass fractions, with reference to existing documents, where relevant (see Clause 6).
The continuous drop method intends to simulate dust generation processes where there are continuous falling operations (conveying, discharging, filling, refilling, weighing, sacking, metering, loading, unloading etc.) and where dust is liberated by winnowing during falling. It can be modified to measure the thoracic fraction as well, but this modification is not described in this document. It differs from the rotating drum method presented in EN 15051-2 [4] in that in this document, the bulk material is dropped only once, but continuously, while in EN 15051 2, the same bulk material is repeatedly dropped.
Furthermore, this document specifies the environmental conditions, the sample handling and analytical procedures and the method of calculating and presenting the results. A categorization scheme for dustiness is specified, to provide a standardized way to express and communicate the results to users of the bulk materials.
This document is applicable to powdered, granular or pelletised bulk materials.
This document is not applicable to test the dust released when solid bulk materials are mechanically treated (e.g. cut, crushed).

 

Odbor: HZN/TO 146 (Kvaliteta zraka)
Ustanova izvornika:
Rok za komentiranje: 2024-08-19
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This document describes the methodology for measuring and characterizing the dustiness of bulk materials that contain or release respirable NOAA or other respirable particles, under standard and reproducible conditions and specifies for that purpose the vortex shaker method.
This document specifies the selection of instruments and devices and the procedures for calculating and presenting the results. It also gives guidelines on the evaluation and reporting of the data.
The methodology described in this document enables:
a) the measurement of the respirable dustiness mass fraction;
b) the measurement of the number-based dustiness index of respirable particles in the particle size range from about 10 nm to about 1 µm;
c) the measurement of the number-based emission rate of respirable particles in the particle size range from about 10 nm to about 1 µm;
d) the measurement of the number-based particle size distribution of the released respirable aerosol in the particle size range from about 10 nm to 10 µm;
e) the collection of released airborne particles in the respirable fraction for subsequent observations and analysis by electron microscopy.
This document is applicable to the testing of a wide range of bulk materials including nanomaterials in powder form.
NOTE 1 With slightly different configurations of the method specified in this document, dustiness of a series of carbon nanotubes has been investigated ([5] to [10]). On the basis of this published work, the vortex shaker method is also applicable to nanofibres and nanoplates.
This document is not applicable to millimetre-sized granules or pellets containing nano-objects in either unbound, bound uncoated and coated forms.
NOTE 2 The restrictions with regard to the application of the vortex shaker method on different kinds of nanomaterials result from the configuration of the vortex shaker apparatus as well as from the small size of the test sample required. Eventually, if future work will be able to provide accurate and repeatable data demonstrating that an extension of the method applicability is possible, the intention is to revise this document and to introduce further cases of method application.
NOTE 3 As observed in the pre-normative research project [4], the vortex shaker method specified in this document provides a more energetic aerosolization than the rotating drum, the continuous drop and the small rotating drum methods specified in EN 17199 2 [1], EN 17199 3 [2] and EN 17199 4 [3], respectively. The vortex shaker method can better simulate high energy dust dispersion operations or processes where vibration or shaking is applied or even describe a worst case scenario in a workplace, including the (non-recommended) practice of cleaning contaminated worker coveralls and dry work surfaces with compressed air.
NOTE 4 Currently no classification scheme in terms of dustiness indices or emission rates has been established according to the vortex shaker method. Eventually, when a large number of measurement data has been obtained, the intention is to revise the document and to introduce such a classification scheme, if applicable.
Odbor: HZN/TO 550 (Opskrba vodom)
Ustanova izvornika:
Rok za komentiranje: 2024-08-19
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This document applies to flushing valves for WCs and valves for urinals, with automatic hydraulic closure, intended for:
- WC pans EN 997;
- single flush urinals EN 13407;
- siphon acting urinals EN 13407.
It does not apply to no-contact detection valves.
It is intended to specify:
- marking and identification, physico-chemical, dimensional, leaktightness, pressure behaviour, hydraulic, mechanical endurance and acoustic characteristics of flushing valves for WCs and urinals with automatic closure;
- test methods used to verify these characteristics;
- and to determine requirements for the atmospheric interrupter which shall be an integral part of the WC flushing valve.
It applies in the following pressure and temperature conditions:
Table 1 — Conditions of use for tapware
Dynamic Pressure range recommended for a good working Urinals
WC DN 15
WC DN 20 0,1 MPa ≤ P ≤ 0,5 MPa
(1 bar ≤ P ≤ 5 bar)
WC DN 25 0,08 MPa ≤ P ≤ 0,25 MPa
(0,8 bar ≤ P ≤ 2,5 bar)
WC DN 32 0,08 MPa ≤ P ≤ 0,25 MPa
(0,8 bar ≤ P ≤ 2,5 bar)
Maximum static pressure 1 MPa (10 bar)
Water temperature ≤ 25 °C
NOTE 1 Although this document limits the pressure for WC DN 25 and WC DN 32 valves till 0,25 MPa (2,5 bar), some European countries have legislation and recommendations for higher pressures.
Health and quality requirements in accordance to European and national legislation for final materials in contact with water intended for human consumption are not covered by this document.