Zdraví, životní prostředí a zdravotní zařízení

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 230 (Water analysis)
Původce: CEN
K připomínkám do: 24.09.2018
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This document specifies a method for the measurement of 99Tc in all types of waters by liquid scintillation counting (LSC).

The method is applicable to test samples of supply/drinking water, rainwater, surface and ground 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 and the instrument used. The method described in this standard, using currently available LSC counters, has a detection limit of approximately 5 Bq·kg-1 to 20 Bq·kg-1, which is lower than the WHO criteria for safe consumption of drinking water (100 Bq·l-1). These values can be achieved with a counting time of 30 min for a sample volume varying between 14 ml to 40 ml. The method presented in this standard is not intended for the determination of ultra-trace amount of 99Tc.

The activity concentration values in this document are expressed by sample mass unit instead of sample volume unit as it is usually the case in similar standards. The reason is that 99Tc is measured in various matrix types such as fresh water or sea water, which have significant density differences. The activity concentration values can be easily converted to sample volume unit by measuring the sample volume. However, it increases the uncertainty on the activity concentration result.

The method described in this standard is applicable in the event of an emergency situation, but not if 99mTc is present at quantities that could cause interference and not if 99mTc is used as a recovery tracer.

The analysis of Tc 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.

Komise : CEN/TC 216 (Chemical disinfectants and antiseptics)
Původce: CEN
K připomínkám do: 25.09.2018
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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.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 230 (Water analysis)
Původce: CEN
K připomínkám do: 25.09.2018
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This document specifies a method for the measurement of 99Tc in all types of waters by inductively coupled plasma mass spectrometry (ICP-MS).

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

The detection limit depends on the sample volume and the instrument used. The method described in this standard, using currently available ICP-MS, has a detection limit of approximately 0,2 ng·kg-1 to 0,5 ng·kg-1 (0,1 Bq·kg-1 to 0,3 Bq·kg-1), which is much lower than the WHO criteria for safe consumption of drinking water (100 Bq·l-1). The method presented in this standard is not intended for the determination of ultra-trace amount of 99Tc.

The mass concentration values in this document are expressed by sample mass unit instead of sample volume unit as it is usually the case in similar standards. The reason is that 99Tc is measured in various matrix types such as fresh water or sea water, which have significant density differences. The mass concentration values can be easily converted to sample volume unit by measuring the sample volume. However, it increases the uncertainty on the mass concentration result.

The method described in this standard is applicable in the event of an emergency situation, but not if 99mTc is present at quantities that could cause interference.

The analysis of Tc 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.

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 25.09.2018
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This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, forgeable and cold-formed cobalt-chromium-nickel-molybdenum-iron alloy for use in the manufacture of surgical implants.

NOTE          The mechanical properties of a sample obtained from a finished product made of this alloy may not necessarily comply with those specified in this part of ISO 5832.

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 25.09.2018
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This part of ISO 5832 specifies the characteristics of, and corresponding test methods for, wrought stainless steel for use in the manufacture of surgical implants.

NOTE 1       The mechanical properties of a sample obtained from a finished product made of this alloy can differ from those specified in this part of ISO 5832.

NOTE 2       The alloy described in this part of ISO 5832 corresponds to UNS S31673 referred to in ASTM F 138 [1]/ASTM F 139 [2] and to alloy code 1.4441 given in the withdrawn DIN 17443.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 162 (Protective clothing including hand and arm protection and lifejackets)
Původce: CEN
K připomínkám do: 30.09.2018
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This document specifies the requirements and test methods for ergonomics, innocuousness, comfort/sizing, restraint, ability to limit wrist extension and attenuate impact force on the palm as well as provisions for marking and instructions supplied by the manufacturer for wrist protectors for all users of snowboard equipment. It does not apply to protectors used in roller sports, alpine skiing, or other sports. This standard does not address protection for the forearm due to axial forces caused by an impact on the fingers or fist. Moreover, this standard does not address protection against palmar flexion (terminal flexion) caused by an impact on the dorsal side of the hand.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 30.09.2018
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This document specifies a framework for the identification of biological hazards and the estimation and control of biological risks from material constituents, using a stepwise approach to the characterization of a medical device through:

—    the identification of its materials of construction (medical device configuration);

—    the characterization of the materials of construction via the identification and quantification of their chemical constituents (material composition);

—    the characterization of the medical device for chemical substances that were introduced during manufacturing (e.g., mould release agents, process contaminants);

—    the estimation of the potential of the medical device, or its materials of construction, to release chemical substances under clinical use conditions (extractables);

—    The measurement of chemical substances released from a medical device under its clinical conditions of use (leachables).

This document may also be used for chemical characterization (e.g., the identification and/or quantification) of degradation products. Information on other aspects of degradation assessment are covered in ISO 10993-9, ISO 10993-13, ISO 10993-14 and ISO 10993-15.

The ISO 10993 series of standards is applicable when the material or medical device has direct or indirect body contact (see ISO 10993-1 for categorization by nature of body contact).

This document is intended for suppliers of materials and manufacturers of medical devices, to support a biological evaluation.

Oblast zaměření: Ochranné oděvy a vybavení
Komise : CEN/TC 162 (Protective clothing including hand and arm protection and lifejackets)
Původce: CEN
K připomínkám do: 1.10.2018
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This document specifies design requirements of protective garments that minimize the risk of its entanglement or drawing-in by moving parts when the wearer is working at or near hazardous moving machines or devices, complementary to the general requirements as stated in EN ISO 13688.

This document does not include protective clothing against injuries by special moving machine parts for which specific standards exist, e.g. protective clothing for user of chainsaws (EN ISO 11393).

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 137 (Assessment of workplace exposure)
Původce: CEN
K připomínkám do: 1.10.2018
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This document specifies general requirements for the measurement of microorganisms and microbial compounds.

This document provides also guidelines for the assessment of workplace exposure to airborne microorganisms including the determination of total number and culturable number of microorganisms and microbial compounds in the workplace atmosphere.

This document does not apply to the measurement of viruses.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 13.10.2018
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This International Standard specifies requirements for suction catheters, made of flexible materials and intended for use in suctioning of the respiratory tract.

Suction catheters intended for use with flammable anaesthetic gases or agents, lasers or electrosurgical equipment are not covered by this International Standard.

NOTE          See ISO/TR 11991 for guidance on airway management during laser surgery of the upper airway.[5]

Komise : CEN/TC 183 (Waste management)
Původce: CEN
K připomínkám do: 15.10.2018
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This document provides a set of CANopen application profile specifications that describes the CleANopen embedded body control network of municipal vehicles, e.g. refuse collecting trucks.

It specifies the CANopen communication interfaces and the application functionality of several functional elements (virtual devices).

It does not specify CANopen devices.

The CleANopen application profile specifications consist of several parts dealing with the following:

general definitions;

functionality of the virtual devices;

pre‑defined PDOs and SDOs;

application objects.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 230 (Water analysis)
Původce: CEN
K připomínkám do: 16.10.2018
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The document specifies the determination of radium-226 (226Ra) and radium-228 (228Ra) activity concentrations in drinking water samples by chemical separation of radium and its measurement using liquid scintillation counting. 226Ra and 228Ra are present in the environment as radionuclides from the 238U and 232Th decay series, as shown in Annex A.

The test method applies to the analysis of 0,5 kg of drinking water containing less than 100 mg/kg barium. If the barium concentration is higher than 100 mg/kg, it is recommended to reduce the volume of the test sample to be analysed so that the total content of barium in the sample does not exceed 50 mg.

Activity concentrations of 226Ra and 228Ra can vary widely according to local geological and climatic characteristics. 226Ra activity concentration range from some mBq/l in surface waters up to several tens of Bq/l in some natural groundwaters[8]; the guidance level for 226Ra in drinking water as recommended by WHO is 1 Bq/l[3][9]. 228Ra activity concentration range from a few mBq/l in surface waters up to several Bq/l in some natural groundwaters[8]; the guidance level for 228Ra in drinking water as recommended by WHO is 0,1 Bq/l[3][9].

Activity concentrations of 226Ra and 228Ra which can be measured by this test method utilizing currently available liquid scintillation counters goes down to 0,01 Bq/kg for 226Ra and 0,06 Bq/kg for 228Ra for a 0,5 kg sample mass and a 1 h counting time in a low background liquid scintillation counter.[10]

NOTE          Adjustment of the test sample mass and counting time can lead to lower detection limits. As an example, a limit of detection of 0,04 Bq/kg can be achieved for 228Ra using a 0,5 kg test sample and a 2 h counting time; similarly a limit of detection of 0,02 Bq/kg can be achieved for 228Ra using a 1 kg test sample and a 2 h counting time.

The test method can be used for the fast detection of contamination of drinking water by radium in emergency situations or for routine environmental monitoring purposes.

Oblast zaměření: Kvalita vody a dodávka vody
Komise : CEN/TC 230 (Water analysis)
Původce: CEN
K připomínkám do: 29.10.2018
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This document is focused on the structural features of rivers, on geomorphological and hydrological processes, and on river continuity. It provides guidance on the features and processes to be taken into account when characterizing and assessing the hydromorphology of rivers. It is based on methods developed, tested, and compared in Europe. Its main aim is to improve the comparability of hydromorphological assessment methods, data processing and interpretation. Although it has particular importance for the WFD by providing guidance on assessing hydromorphological quality, it has considerably wider scope for other applications. In addition, while recognizing the important influence of hydromorphology on plant and animal ecology, no attempt is made to provide guidance in this area, but where the biota have an important influence on hydromorphology these influences are included.

NOTE          A case study illustrating the application of this standard is given in Gurnell and Grabowski[1].

Oblast zaměření: Kvalita ovzduší
Komise : CEN/TC 243 (Cleanroom technology)
Původce: CEN
K připomínkám do: 29.10.2018
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This document establishes the requirements, recommendations and methodology for microbiological contamination control in clean controlled environments. It also sets out the requirements for establishing and demonstrating microbiological control in clean controlled environments.

This document is limited to viable microbiological contamination and excludes any considerations of endotoxin, prion and viral contamination.

There is specific guidance given on common applications, including Pharma/BioPharma, Medical Devices, Hospitals and Food.

Oblast zaměření: Akustika a zvuková izolace
Komise : CEN/TC 126 (Acoustic properties of building products and of buildings)
Původce: CEN
K připomínkám do: 6.11.2018
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Amendment