Zdraví, životní prostředí a zdravotní zařízení

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 25.03.2019
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This document specifies requirements and test methods for spoons and bone curettes used in dentistry for oral surgical procedures.

It specifies shapes and dimensions as well as information for marking.

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 25.03.2019
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This document specifies methods for keeping test organisms used and defined in European Standards for the determination of bactericidal (incl. Legionella pneumophila), mycobactericidal, sporicidal, fungicidal and virucidal (incl. bacteriophages) activity of chemical disinfectants and antiseptics drawn up by CEN/TC 216. These methods for keeping test organisms can only be carried out in connection with at least one of those standards where a reference to this document is established.

NOTE 1       Annex A (informative) contains a non-exhaustive list of test organisms for which this document can be applied.

NOTE 2       European Standards (EN and prEN) where this document is referenced are listed in the Bibliography.

NOTE 3       A specific part on the preservation of bacterial spores could be added once the results of the ongoing ring trials are available.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 137 (Assessment of workplace exposure)
Původce: CEN
K připomínkám do: 25.03.2019
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This document specifies the determination of the size weighted fine fraction (SWFF) and the size weighted fine fraction of crystalline silica (SWFFCS) in bulk materials by calculation. The document also describes the assumptions and preconditions to be fulfilled in order for this method to be valid.

The purpose of this document is to allow users to evaluate bulk materials with regard to their size-weighted fine fraction and crystalline silica content.

The calculation method is applicable only after experiments have shown that the results are accurate and consistently equal or higher than the results from sedimentation, as described in prEN 17289‑3:2018, for that particular bulk material.

For preparation of the sample and determination of crystalline silica by XRD and FT-IR see prEN 17289‑1:2018.

A specific method for the evaluation of the SWFF for diatomaceous earth bulk materials is given in Annex A. Due to the internal porosity of diatomaceous earth, the general instructions given in this document are adapted in order to take into account the material’s effective density.

This document is applicable for bulk materials which have been fully investigated and validated. The criteria for the materials are described in this document and prEN 17289‑3:2018. This includes industrial minerals which can contain crystalline silica such as quartz, clay, kaolin, talc, feldspar, mica, cristobalite, vermiculite, diatomaceous earth, barite, andalusite, iron ore, chromite etc.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 264 (Air quality)
Původce: CEN
K připomínkám do: 25.03.2019
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This document specifies a method for the sampling and analysis of NH3 in ambient air using diffusive sampling.

It can be used for NH3 measurements at ambient levels, but the concentration range and exposure time are sampler dependent, and the end user is therefore advised to comply with the operating instructions provided by the manufacturer.

NOTE          Denuders may be used as a surrogate reference method until there are improvements in the continuous optical methods.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 137 (Assessment of workplace exposure)
Původce: CEN
K připomínkám do: 25.03.2019
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This document specifies the determination of the size weighted fine fraction (SWFF) and the size weighted fine fraction of crystalline silica (SWFFCS) in bulk materials by means of a sedimentation method using a liquid sedimentation technique.

The purpose of this document is to allow users to evaluate bulk materials with regard to their size-weighted fine fraction and crystalline silica content.

For preparation of the sample and determination of crystalline silica by XRD and FT-IR see prEN 17289‑1:2018.

Annex A to Annex E describe specific methods for the evaluation of SWFF for specific bulk materials.

This document is applicable for bulk materials which have been fully investigated and validated. The criteria for the materials are described in this document and prEN 17289‑2:2018. This includes industrial minerals which can contain crystalline silica such as quartz, clay, kaolin, talc, feldspar, mica, cristobalite, vermiculite, diatomaceous earth, barite, andalusite, iron ore, chromite etc.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 137 (Assessment of workplace exposure)
Původce: CEN
K připomínkám do: 25.03.2019
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This document specifies the the requirements and choice of test method for the determination of the size weighted fine fraction (SWFF) and the size weighted fine fraction of crystalline silica (SWFFCS) in bulk materials.

This document gives also guidance on the preparation of the sample and determination of crystalline silica by XRD and FT-IR.

NOTE          prEN 17289‑2:2019 specifies a method to estimate the size-weighted fine fraction from a measured particle size distribution and assumes that the particle size distribution of the crystalline silica particles is the same as the other particles present in the bulk material. prEN 17289‑3:2019 specifies a method using a liquid sedimentation technique to determine the size-weighted fine fraction of crystalline silica. Both methods are based upon a number of limitations and assumptions, which are listed in prEN 17289‑2:2019 and prEN 17289‑3:2019, respectively. The method in prEN 17289‑3:2019 can also be used for other constituents, if investigated and validated.

This document is applicable for bulk materials which have been fully investigated and validated. The criteria for the materials are described in prEN 17289‑2:2019 and prEN 17289‑3:2019. This includes industrial minerals which can contain crystalline silica such as quartz, clay, kaolin, talc, feldspar, mica, cristobalite, vermiculite, diatomaceous earth, barite, andalusite, iron ore, chromite etc.

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 29.03.2019
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This document specifies a process for a medical laboratory to identify and manage the risks to patients, laboratory workers and service providers that are associated with medical laboratory examinations. The process includes identifying, estimating, evaluating, controlling and monitoring the risks.

The requirements of this document are applicable to all aspects of the examinations and services of a medical laboratory, including the pre-examination and post-examination aspects, examinations, accurate transmission of test results into the electronic medical record and other technical and management processes described in ISO15189.

This document does not specify acceptable levels of risk.

This document does not apply to risks from post-examination clinical decisions made by healthcare providers.

This document does not apply to the management of risks affecting the medical laboratory enterprise that are addressed by ISO 31000, such as business, economic, legal, and regulatory risks.

NOTE   International, national, or regional regulations or requirements may also apply to specific topics covered in this international standard

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 230 (Water analysis)
Původce: CEN
K připomínkám do: 1.04.2019
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This document specifies a method for the measurement of 210Po in all types of waters by alpha spectrometry.

The method is applicable to test samples of supply/drinking water, rainwater, surface and ground water, marine water, as well as cooling water, industrial water, domestic, and industrial wastewater after proper sampling and handling, and test sample preparation. A filtration of the test sample is necessary.

The detection limit depends on the sample volume, the instrument used, the background count rate, the detection efficiency and the chemical yield. The method described in this document, using currently available alpha spectrometry apparatus, has a detection limit of approximately 5 mBq.l-1, which is lower than the WHO criteria for safe consumption of drinking water (100 mBq·l-1). This value can be achieved with a counting time of 24 hours for a sample volume of 500 ml.

The method described in this document is applicable in the event of an emergency situation.

The analysis of 210Po adsorbed to suspended matter is not covered by this method.

It is the user’s responsibility to ensure the validity of this test method for the water samples tested.

If suspended material has to be removed or analysed, filtration at 0,45 μm is recommended. The analysis of the insoluble fraction requires a mineralization step that is not covered by this document (see NF M 60‑790‑4[13]). In this case, the measurement is made on the different phases obtained. The final activity is the sum of all the measured activity concentrations.

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 264 (Air quality)
Původce: CEN
K připomínkám do: 2.04.2019
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This document contains specifications for active sampling of bioaerosols from exhaust air flowing through a defined cross-section of a stack. It defines general principles that have to be taken into account during an isokinetic sampling campaign for bioaerosols by bubbling the exhaust air through a specific impinge designed for emission measurements.

In this document the application with culturable organisms is specified but the same principle might be applicable for non-cultural based methods (e.g. molecular and/or enzyme-based methods).

The impinger is designed to allow a sample volume flow of 1 m3/h to 1,8 m3/h, or 16 l/min to 30 l/min, respectively, and has been tested with regard to various microorganisms within broad concentration ranges [1; 2; 3; 4]. [1])

 

[1]) This method is accepted by convention as reference method for determination of total emissions under application of an out stack configuration according to EN 13284-1.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 3.04.2019
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This document specifies requirements and test methods to assess the thermomechanical compatibility between a veneering ceramic and a metallic or ceramic substructure material used for dental restorations.

This document applies only to the materials when used in combination. Compliance cannot be claimed for a single material.

For requirements for ceramic materials, see ISO 6872. For requirements for metallic materials see ISO 22674.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 10.04.2019
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This document specifies evaluation procedures applicable to elastomeric parts including coated stoppers used for drug containers and medical devices in order to guarantee the product identity. The physical and chemical test procedures specified in this document permit the determination of the typical characteristics of elastomeric parts, and can serve as a basis for agreements between manufacturer and user regarding the product consistency in subsequent supplies. An appropriate set of tests is selected, depending upon the type of elastomer and its application.

This document does not specify other requirements for elastomeric parts. These are laid down in the relevant product standards.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 30.04.2019
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This document provides a selective vocabulary of terminological concepts used for the development of dental product standards in the interest of facilitating the standard development process and comprehension of standards, and to improve communication with the FDI World Dental Federation, the World Health Organization and other organizations interested in the field of standardization.

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 126 (Acoustic properties of building products and of buildings)
Původce: CEN
K připomínkám do: 3.05.2019
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This part of ISO 12999 specifies procedures for assessing the measurement uncertainty of sound insulation in building acoustics. It provides for

—    a detailed uncertainty assessment;

—    a determination of uncertainties by inter-laboratory tests;

—    an application of uncertainties.

Furthermore, typical uncertainties are given for quantities determined according to ISO 10140, ISO 16283 and ISO 717 (all parts).

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 162 (Protective clothing including hand and arm protection and lifejackets)
Původce: CEN
K připomínkám do: 6.05.2019
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This document specifies requirements for enhanced visibility equipment in the form of garments, or devices, which are capable of visually signalling the user’s presence.

The enhanced visibility equipment is intended to provide conspicuity of the wearer in medium risk situations under any daylight conditions and/or under illumination by vehicles headlights or searchlights in the dark.

Performance requirements are included for colour and retroreflection as well as for the minimum areas and for the placement of the materials in protective equipment.

This document is not applicable to:

•       high visibility equipment in high-risk situations, which is covered in EN ISO 20471 (for further information concerning risk situations, see Annex A);

•       visibility equipment specifically intended for the head, hands and feet, e.g. helmets, gloves and shoes;

•       equipment integrating active lighting, e.g. LEDs.

Komise : CEN/TC 140 (In vitro diagnostic medical devices)
Původce: CEN
K připomínkám do: 6.05.2019
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This international standard specifies technical requirements and documentation necessary to establish metrological traceability of values assigned to calibrators, trueness control materials and human samples for quantities measured by IVD MDs. The human samples are those intended to be measured, as specified for each IVD MD. Metrological traceability of values for quantities in human samples extends to the highest available reference system component, ideally to RMPs and certified reference materials (CRMs).

All parties having a role in any of the steps described in a calibration hierarchy for an IVD MD are subject to the requirements described. These parties include but are not limited to manufacturers (of IVD MDs), RMP developers (see ISO 15193), RM producers (see ISO 15194), and reference/calibration laboratories (see ISO 15195) supporting calibration hierarchies for IVD MDs.

NOTE Producers of RMs intended for use in standardization or calibration of IVD MDs include commercial and non-commercial organizations producing RMs for use by many end-users of IVD MDs and/or calibration laboratories, or for use by a single end-user medical laboratory, as in the case of a measurement standard (calibrator) intended to be used exclusively for calibration of a laboratory-developed MP.

This international standard is applicable to:

a)     all IVD MDs that provide measurement results in the form of numeric values, i.e. rational (ratio) and/or differential (interval) scales, and counting scales

b)    IVD MDs where the measurement result is reported as a qualitative value established with a ratio of two measurements (i.e. the signal from a specimen being tested and the signal from a RM with a specified concentration or activity at the cut-off), or a counting scale, with corresponding decision threshold(s). This also includes IVD MDs where results are categorized among ordinal categories based on pre-established quantitative intervals for a quantity.

c)     RMs intended for use as trueness control materials for verification or assessment of calibration of IVD MDs, i.e. some commutable CRMs and some external quality assessment (EQA) materials (if so indicated in the RM’s intended use statement)

d)    IVD MD-specific calibrators and trueness control materials with assigned values, intended to be used together with a specified IVD MD.

e)     IVD MDs as described in a) and b), where no end-user performed calibration is required (i.e. when the manufacturer performs a factory calibration of the IVD MD).

This international standard is not applicable to:

a)     calibrators and trueness control materials for IVD MDs which, due to their formulation, are known to have zero amount of measurand.

b)    control materials that are used only for internal quality control purposes in medical laboratories to assess the imprecision of an IVD MD, either its repeatability or reproducibility, and/or for assessing changes in IVD MD results compared to a previously established calibration condition;

c)     control materials that are used only for internal quality control purposes in medical laboratories and which are supplied with intervals of suggested acceptable values that are not metrologically traceable to higher order reference system components;

d)    properties reported as nominal scales and ordinal scales, where no magnitude is involved

NOTE 1       Nominal scales are typically used to report e.g. identity of blood cell types, microorganism types, identity of nucleic acid sequences, identity of urine particles.

NOTE 2       Ordinal scales are often applied to results differentiated into dichotomous groupings (e.g. ‘sick’ vs. ‘healthy’), and may also be applied to results differentiated into non-dichotomous categories where the result categories are rank-ordered but the rank-ordered categories cannot be differentiated in terms of relative degree of difference, e.g. negative, +1, +2, +3 for grading of presence of haemoglobin in urine specimens by visual observation.