Zdraví, životní prostředí a zdravotní zařízení

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 211 (Acoustics)
Původce: CEN
K připomínkám do: 16.07.2019
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This document establishes general rules for the acoustic testing of air-terminal units, dampers and valves used in air diffusion and air distribution systems in order to determine sound power levels as defined in ISO 3741.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 450 (Patient involvement in person-centred care)
Původce: CEN
K připomínkám do: 31.07.2019
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This document specifies the minimum requirements enabling patient involvement in health care services with the aim to create favourable structural conditions for person-centred care.

It is intended to be used before, during and after the actual care provided by care personnel and to be available for use by the patient who is the recipient of the care.

This document is also intended to be used on a strategic level for quality assurance and improvement, during procurement, education and supervision as well as to be used as a guiding document for research and development projects within intervention and implementation of person-centred care.

Oblast zaměření: Sterilizace zařízení
Komise : CEN/TC 102 (Sterilizers and associated equipment for processing of medical devices)
Původce: CEN
K připomínkám do: 2.08.2019
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This document specifies procedures and test methods used to demonstrate the cleaning efficacy of washer-disinfectors (WD) and their accessories intended to be used for cleaning of re-usable medical devices and other items used in medical, dental, pharmaceutical and veterinary practice.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 6.08.2019
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This document specifies requirements and test methods for external tooth bleaching products. These products are intended for use in the oral cavity, either by professional application (in-office tooth bleaching products) or consumer application (professional or non-professional home use of tooth bleaching products), or both. It also specifies requirements for their packaging, labelling and instructions for use. Maximum concentration of a bleaching agent for professional or non-professional use is subject to each country’s regulatory body.

This document is not applicable to tooth bleaching products:

—    specified in ISO 11609;

—    those intended to change colour perception of natural teeth by mechanical methods (e.g. stain removal) or using restorative approaches, such as veneers or crowns;

—    auxiliary or supplementary materials (e.g. tray materials) and instruments or devices (e.g. lights) that are used in conjunction with the bleaching products.

This document does not specify biological safety aspects of tooth bleaching products.

NOTE          A tooth bleaching product can be evaluated for its biological safety using ISO 10993‑1[2] and ISO 7405[3].

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 6.08.2019
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This document specifies dimensional and other requirements for the 11 most commonly used carbide cutters which are predominantly used in the dental laboratory.

NOTE       These cutters are also used in podiatry.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 6.08.2019
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ISO 18190:2016 Clause 1 is replaced by:

This document specifies minimum performance and safety requirements for air entrainment devices used for delivery of designated oxygen concentrations to patients and includes a test method to check the accuracy of the oxygen concentration in the air/oxygen mixture generated by the air entrainment devices. Air entrainment devices can be a fixed to deliver a single oxygen concentration or adjustable, to deliver a range of oxygen concentration outputs.

It also specifies marking requirements and recommends an optional system of colour coding to assist the user in identifying the designated oxygen concentration.

This document does not cover air entrainment devices which are integral with medical devices specified in other standards e.g. emergency lung ventilators, humidifiers, nebulizers, etc.

Oblast zaměření: Environmentální management
Komise : CEN/TC 406 (Project Committee - Mechanical products – Ecodesign methodology)
Původce: CEN
K připomínkám do: 12.08.2019
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This document describes a methodology for reducing the overall environmental impact through product design and development that is tailored to mechanical products as defined in 3.1.

This methodology is particularly well suited to the redesign of an existing product; it can also be applied for the design of a new product provided the necessary assumptions regarding a (virtual) reference product are taken.

It addresses companies which have decided to integrate an ecodesign approach to optimize environmental impacts within the product life cycle, in relation to the other product aspects, such as functionality, quality, costs, etc.

It also helps to meet some requirements of ISO 14001:2015 on the integration of environmental aspects in the design of products.

NOTE 1       This document targets persons who are directly involved in the design and development of mechanical products, as well as managers responsible for defining corporate policies, and decision-makers. The proposed methodology is intended to kick-start ecodesign initiatives within companies as part of a teaching and continuous improvement approach.

This document also includes a template that companies can use as part of the communication on their environmental approach.

This document is neither intended nor suitable to compare products (even similar) of different suppliers.

This document is neither intended nor suitable for product certification purposes.

NOTE 2       An example of implementation of the methodology is given in Annex D; the basic principles for the establishment of this method are given in Annex E.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 264 (Air quality)
Původce: CEN
K připomínkám do: 12.08.2019
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This document specifies a method for the objective determination of the odour concentration of a gaseous sample using dynamic olfactometry with human assessors. The standard also specifies a method for the determination of the emission rate of odours from stationary sources, in particular:

point sources (conveyed or ducted emissions);

active area sources (e.g. biofilters);

passive sources.

The primary application of this standard is to provide a common basis for evaluation of odour emissions.

When this document is used for the determination of the odour concentration or the odour emission rate of stationary source emissions, the other relevant European Standards concerning stationary source emissions apply, in particular EN 15259 and EN 16911-1, especially when measurements have to be in compliance with the relevant European Directives concerning industrial air emissions.

Even so, the analysis/quantification step of the measurement method described in this document (i.e. the determination of the odour concentration of an odorous gas sample, without respect to the origin of the sample itself) can be fully applied in many cases not related with industrial emission sources (e.g. the measurement of the mass concentration at the detection threshold of pure odorous substances, the determination of effectiveness of deodorizing systems for indoor air). In those latter cases, the requirements in this document concerning the measurement planning and the sampling of stationary sources  can be ignored or adapted.

This document is applicable to the measurement of odour concentration of pure substances, defined odorant compounds and undefined mixtures of odorant volatiles in air or nitrogen, using dynamic olfactometry with a panel of human assessors being the sensor. The unit of measurement is the European odour unit per cubic metre: ouE/m3. The odour concentration is measured by determining the dilution factor required to reach the detection threshold. The odour concentration at the detection threshold is by definition 1 ouE/m3. The odour concentration is then expressed in terms of multiples of the detection threshold. The range of measurement is typically from 101 ouE/m3 to 107 ouE/m3 (including pre‑dilution).

The field of application of this document includes:

the measurement of the mass concentration at the detection threshold of pure odorous substances in g/m3;

the determination of the EROM value of odorants, in mol;

the measurement of the odour concentration of mixtures of odorants in ouE/m3;

the measurement of the emission rate of odorous emissions from point sources, active area sources and passive area sources, including pre‑dilution during sampling;

the sampling of odorous gases from emissions of high humidity and temperature (up to 200 °C);

the determination of effectiveness of end-of-pipe mitigation techniques used to reduce odour emissions.

The determination of odour emissions requires measurement of gas velocityto determine the gas volume flow rate.

The field of application of this document does not include:

the measurement of odours potentially released by particles of odorous solids or droplets of odorous fluids suspended in emissions;

the measuring strategy to be applied in case of variable emission rates;

the measurement of the relationship between odour stimulus and assessor response above detection threshold (perceived intensity);

measurement of hedonic tone (or (un)pleasantness) or assessment of annoyance potential;

direct measurement of odour exposure in ambient air. For this measurement purpose, field panel methods exist which are the subject of CEN standard EN 16841-1, Ambient Air - Determination of odour in ambient air by using field inspection - Grid method;

direct olfactometry, including field olfactometry;

static olfactometry;

measurement of odour recognition thresholds;

measurement of odour identification thresholds.

Although the ultimate application of odour concentration measurement is aimed at reducing odour nuisance, the relation between emissions, dispersion, exposure and annoyance is not within the scope of this document. The relation between measured odour concentrations and odour emissions according to this standard and the occurrence of odour nuisance is highly complex. It is profoundly influenced by the atmospheric processes determining the dispersion of odours, the quality of the odour (hedonic tone) and finally by the receptor characteristics of those exposed to the odour. These receptor characteristics not only vary strongly between individuals, but also in time within one individual.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 230 (Water analysis)
Původce: CEN
K připomínkám do: 19.08.2019
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This part of ISO 5667 sets out the general principles for, and provides guidance on, the design of sampling programmes and sampling techniques for all aspects of sampling of water (including waste waters, sludges, effluents, suspended solids and  sediments).

It does not include detailed instructions for specific sampling situations, which are covered in the various other parts of ISO 5667 and in ISO 19458.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 26.08.2019
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This document specifies requirements and gives the test method for medical gloves for single use in order to determine freedom from holes.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 230 (Water analysis)
Původce: CEN
K připomínkám do: 1.09.2019
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This document provides guidelines to enable testing laboratory using rapid test methods on all types of water samples that may be contaminated following a nuclear or radiological emergency situation:

—    taking into account the specific context for the tests to be performed, e.g. an unknown and potentially unusual high level of contamination;

—    using or adjusting, when possible, radioactivity test method implemented during routine situation to obtain a result rapidly or applying specific rapid test methods previously validated by the laboratory, e.g. for 89Sr determination;

—    preparing the test laboratory to measure a large number of potentially contaminated samples.

The aim of this document is to ensure decision makers have reliable results needed to take actions on time and minimize the dose to the public.

Measurements are performed in order to minimize the risk for the public in checking the water quality of water supplies. For emergency situations, test results are compared to operational intervention levels.

Note:            Operational intervention levels (OILs) are derived from IAEA Safety Standards[13] or national authorities[5].

A key can be to use the usual and routine methods in a faster manner. The goal of these rapid measurements is often to check an unusual radioactivity level in the test sample, to identify the radionuclides and their activity concentration levels and to establish compliance of the sampled water with intervention levels[21]. It should be noted that in such circumstances validation parameters are not always valid (impossible use of standard measuring geometries for gamma spectrometry…) and thus uncertainties associated with the test results may increase.

The first steps of the analytical approach is usually based on gross alpha and gross beta test methods considered as screening methods (adaptation of ISO 10704 and ISO 11704) and gamma spectrometry (adaptation of ISO 20042, ISO 10703 and ISO 19581). Then, when necessary[3], test method standards for specific radionuclides are adapted and applied (for example, 90Sr measurement following ISO 13160) as proposed in Annex A.

This document refers to a set of already published ISO standards. When appropriate, this document also refers to national standards or other publically available documents.

Screening techniques that can be carried out directly in the field are not part of this document.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 164 (Water supply)
Původce: CEN
K připomínkám do: 3.09.2019
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Amendment

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 126 (Acoustic properties of building products and of buildings)
Původce: CEN
K připomínkám do: 3.09.2019
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This part of ISO 12999 specifies the uncertainty of sound absorption coefficients and equivalent sound absorption areas measured according to ISO 354:2003, the practical and weighted sound absorption coefficients according to ISO 11654 and the single number rating according to EN 1793‑1. Furthermore, the use of uncertainties in reporting measured or weighted absorption coefficients is explained.