Hlavní oblasti

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 8.03.2019
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This part of ISO 5840 is applicable to all devices intended for implantation as a transcatheter heart valve substitute (see Annex A for examples).

This part of ISO 5840 is applicable to both newly developed and modified transcatheter heart valve substitutes and to the accessory devices, packaging and labelling required for their implantation and for determining the appropriate size of heart valve substitute to be implanted. 

This part of ISO 5840 outlines an approach for verifying/validating the design and manufacture of a transcatheter heart valve substitute through risk management. The selection of appropriate verification/validation tests and methods are to be derived from the risk assessment. The tests may include those to assess the physical, chemical, biological and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

This part of ISO 5840 defines operational conditions and performance requirements for transcatheter heart valve substitutes where adequate scientific and/or clinical evidence exists for their justification.

This part of ISO 5840 includes considerations for implantation of a transcatheter heart valve substitute inside a pre-existing prosthetic device (e.g. valve-in-valve and valve-in-ring configurations).

Oblast zaměření: Potravinářské produkty
Komise : CEN/TC 338 (Cereals and cereal products)
Původce: CEN
K připomínkám do: 8.03.2019
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This International Standard specifies a method for the determination of the biometric characteristics of husked or milled rice kernels.

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 8.03.2019
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This part of ISO 5840 is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements.

ISO 5840 is applicable to: newly developed and modified heart valve substitutes; the accessory devices, packaging, and labelling required for their implantation; and for determining the appropriate size of the heart valve substitute to be implanted.

ISO 5840 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests may include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute.

ISO 5840 defines operational conditions for heart valve substitutes.

ISO 5840 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices.

NOTE:         A rationale for the provisions of ISO 5840 is given in Annex A.

Oblast zaměření: Navrhování budov
Komise : CEN/TC 442 (Building Information Modelling (BIM))
Původce: CEN
K připomínkám do: 9.03.2019
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This European standard establishes the rules for defining properties used in construction and a methodology for authoring and maintaining them, for a confident and seamless digital share between stakeholders.

Regarding definition of properties and groups of properties, the standard provides:

—    definitions of properties and groups of properties as a list of attributes

—    definition of each attributes

Regarding authoring and maintaining process, the standard provides:

—    definition and role of applicants,

—    definition and role of experts and college of experts,

—    definition of request’s attributes,

—    definition of expert’s attributes,

—    a governance model through the establishment of a steering committee;

—    management rules to interconnect dictionaries through properties and groups of properties mapping proces.

Komise : CEN/TC 169 (Light and lighting)
Původce: CEN
K připomínkám do: 11.03.2019
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This document specifies the parameters of integral lighting systems designed to provide illumination in and/or at both stationary and mobile machines to enable the safe use of the machine and the efficient performance of the visual task within and/or at the machine to be carried out by the operator.

This document does not specify lighting systems mounted on the machine to specifically illuminate visual tasks outside the machine. The function and requirements of these systems are specified in the European Standard dealing with the lighting of work places, see EN 12464‑1 and EN 12464‑2 for further information.

This document does not specify additional requirements for the operation of lighting systems:

—    in severe conditions (extreme environmental conditions such as freezer applications, high temperatures, etc.);

—    subject to special rules (e.g. explosive atmospheres);

—    where the transmittance is reduced by environmental conditions, such as smoke, splashing, etc.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 364 (High Chairs)
Původce: CEN
K připomínkám do: 11.03.2019
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Amendment

Oblast zaměření: Armatury
Komise : CEN/TC 69 (Industrial valves)
Původce: CEN
K připomínkám do: 11.03.2019
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This document provides basic requirements for gearboxes to operate industrial valves for manual and automated on/off and modulating duties, this includes manual override gearboxes. It includes guidelines for classification, design and methods for conformity assessment.

It does not cover gear systems which are integral part in the design of valves and subsea gearboxes.

Other requirements or conditions of use different from those indicated in this document should be agreed between the purchaser and the manufacturer or supplier (first party), prior to order.

Oblast zaměření: Měď
Komise : CEN/TC 133 (Copper and copper alloys)
Původce: CEN
K připomínkám do: 11.03.2019
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Amendment

Oblast zaměření:
Komise : IEC/TC 116 (Safety of motor-operated electric tools)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 12.03.2019
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Amendment

Oblast zaměření: Vláknová optika
Komise : IEC/SC 86A (Fibres and cables)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 12.03.2019
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This part of IEC 60793 contains the general specifications for both multimode and single-mode optical fibres.

Sectional specifications for each of the four categories multimode fibres: A1, A2, A3, and A4 (part of the multimode fibre class A) contain requirements specific to each category.

Sectional specifications for each of the two single-mode fibre classes, B and C, contain requirements common to each class.

Each sectional specification includes family specifications (in normative annexes) that contain requirements for the applicable category or sub-categories. These sub-categories are distinguished on the basis of different fibre types or applications.

The requirements of this standard apply to all classes.

Each sectional specification contains the requirements that are common to all the family specifications that are within it. These common requirements are copied to the family specification for ease of reference.

Tests or measurement methods are defined for each specified attribute. Where possible, these definitions are by reference to an IEC standard – otherwise the test or measurement method is outlined in the relevant sectional specification.

Table 1 defines the sectional specifications. The relevant family specifications are defined within the sectional specifications as normative annexes (see Tables 2 to 5).

Annexes A and B summarize the existing fibre specifications.

Oblast zaměření: Fotovoltaické systémy
Komise : IEC/TC 82 (Solar photovoltaic energy systems)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 12.03.2019
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This document is applicable to organizations manufacturing photovoltaic (PV) modules certified to IEC 61215 series for design qualification and type approval and IEC 61730 for safety qualification and type approval. The design qualification and type approval of PV modules depend on appropriate methods for product and process design, as well as appropriate control of materials and processes used to manufacture the product. This document lays out best practices for product design, manufacturing processes, and selection and control of materials used in the manufacture of PV modules that have met the requirements of IEC 61215 series, IEC 61730, or IEC 62108. These standards also form the basis for factory audit criteria of such sites by various certifying and auditory bodies.

The object of this standard is to provide a framework for the improved confidence in the ongoing consistency of performance and reliability of certified PV modules. The requirements of this document are defined with the assumption that the quality management system of the organization has already fulfilled the requirements of ISO 9001 or equivalent quality management system. By maintaining a manufacturing system in accordance with this standard, PV modules are expected to maintain their performance as determined from the test sequences in IEC 61215 series,  IEC 62108, or IEC 61730..

This standard is applicable to all PV modules independent of design and technology i.e. flat panel, concentrator photovoltaic (CPV). Quality controls for CPV and nonconventional flat-plate manufacturing will differ somewhat from those of more conventional designs; this document has not considered these differences.

Oblast zaměření: Spolehlivost
Komise : IEC/TC 56 (Dependability)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 12.03.2019
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This International Standard is intended to define a procedure to verify if a reliability of an item/system complies with the stated requirements. The requirement is assumed to be specified as the percentage of success (success ratio) or the percentage of failures (failure ratio).

This document can be used where a number of items are tested (trials) and classified as passed or failed. It can also be used where one or a number of items are tested repeatedly. The procedures are based on the assumption that the probability of success or failure is the same from trial to trial (statistically independent events). Planes for fixed trial/failure terminated tests as well as truncated sequential probability ratio tests (SPRT) are included. This document contains extensive tables with ready-to-use SPRT plans and their characteristics for equal and non-equal risks for supplier and customer.

In the case of the reliability compliance tests for constant failure rate/intensity, IEC 61124 should be applied.

Oblast zaměření: Přístrojové transformátory
Komise : IEC/TC 38 (Instrument transformers)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 12.03.2019
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Clause 1 of IEC 61869-1:2007 is applicable, with the following addition:

This part of IEC 61869 is a product standard and covers only additional requirements for stand-alone merging units (SAMUs) used for AC applications having rated frequencies from 15 Hz to 100 Hz. The digital output format specification is not covered by this document. It is standardized in IEC 61869-9 as an application of IEC 61850, which specifies the power utility communication architecture.

This document covers SAMUs having standardized analogue inputs (for example: 1 A, 5 A, 3,25 V / √3 or 100 V / √3) provided by instrument transformers compliant with relevant product standards (both valid and withdrawn e.g., IEC 61869-2 to IEC 61869-5, IEC 61869-10, IEC 61869-11, IEC 60044-1 to IEC 60044-6, IEC 60185, IEC 60186, IEEE C57.13), and aims to convert them to the digital output compliant with IEC 61869-9. Other input and output types are out of the scope of this document. Appropriate SAMU functionality can be combined with switchgear controller functionality defined in IEC 62271-3 or other IED functionality defined in IEC 60255 (all parts).

The general block diagram showing a typical SAMU application example is given in Figure 1302.

Oblast zaměření: Elektrická příslušenství
Komise : IEC/SC 23E (Circuit-breakers and similar equipment for household use)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 12.03.2019
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Amendment

Oblast zaměření: Plasty
Komise : CEN/TC 249 (Plastics)
Původce: CEN
K připomínkám do: 15.03.2019
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This document establishes a system of designation for polyetheretherketone (PEEK) moulding and extrusion materials which may be used as the basis for specifications. Polyetheretherketone polymer chains are composed of phenylene rings linked in (1,4) position by a sequence of two ether groups followed by one ketone group.

1.2     The grades of PEEK plastics are differentiated from each other by a classification system based on appropriate levels of the designatory properties

a)     melt viscosity or melt volume-flow rate,

b)    tensile modulus,

c)     tensile strength

and on information about the intended application and/or method of processing, important properties, additives, colorants, fillers and reinforcing materials.

1.3     The designation system is applicable to all polyetheretherketones.

It applies to materials ready for normal use in the form of powder, granules or pellets, unmodified or modified by colourants, fillers, reinforcements or other additives.

1.4     It is not intended to imply that materials having the same designation necessarily give the same performance. This document does not provide engineering data, performance data or data on processing conditions which may be required to specify a material for a particular application and/or method of processing.

If such additional properties are required, they shall be determined in accordance with the test methods specified in ISO 23153‑2, if suitable.

1.5     In order to specify a thermoplastic material for a particular application or to ensure reproducible processing, additional requirements may be given in data block 5 (see Clause 4.1).

Oblast zaměření: Plasty
Komise : CEN/TC 249 (Plastics)
Původce: CEN
K připomínkám do: 15.03.2019
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This document specifies the methods of preparation of test specimens and the test methods to be used in determining the properties of polyetheretherketone (PEEK) moulding and extrusion materials. Requirements for handling test material and for conditioning both the test material before moulding and the specimens before testing are given.

Procedures and conditions for the preparation of test specimens and procedures for measuring properties of the materials from which these specimens are made are also given. Properties and test methods that are suitable and necessary to characterize PEEK moulding and extrusion materials are listed.

The properties have been selected from the general test methods in ISO 10350‑1. Other test methods in wide use for or of particular significance to these moulding and extrusion materials are also included in this document, as are the designatory properties specified in ISO 23153‑1.

In order to obtain reproducible and comparable test results, it is necessary to use the methods of preparation and conditioning, the specimen dimensions and the test procedures specified herein. Values determined will not necessarily be identical to those obtained using specimens of different dimensions or prepared using different procedures.

Oblast zaměření: Textilie
Komise : CEN/TC 248 (Textiles and textile products)
Původce: CEN
K připomínkám do: 15.03.2019
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This document specifies a method, using benzyl alcohol, to determine the mass percentage of acetate, after removal of non‑fibrous matter, in textiles made of mixtures of

—    acetate

with triacetate, polypropylene, elastolefin, melamine, polypropylene/polyamide bicomponent and polyacrylate fibres.

Oblast zaměření: Textilie
Komise : CEN/TC 248 (Textiles and textile products)
Původce: CEN
K připomínkám do: 15.03.2019
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This part of ISO 1833 specifies a method, using glacial acetic acid, to determine the percentage of acetate, after removal of non-fibrous matter, in textiles made of mixtures of

—    acetate

with

—    certain chlorofibres or after-chlorinated chlorofibres. It is also possible to analyse mixtures containing acetate by using the test methods described in IS0 1833-3 or ISO 1833‑9.

Oblast zaměření: Textilie
Komise : CEN/TC 248 (Textiles and textile products)
Původce: CEN
K připomínkám do: 15.03.2019
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This part of ISO 1833 specifies a method, using carbon disulfide/acetone, to determine the mass percentage of chlorofibre, after removal of non-fibrous matter, in textiles made of mixtures of

certain chlorofibres, with

—    wool, animal hair, silk, cotton, viscose, cupro, modal, lyocell, polyamide, polyester, elastomultiester, acrylic, melamine, polypropylene, polypropylene/polyamide bicomponent, polyacrylate and glass fibres.

Before carrying out the analysis, the solubility of the chlorofibres in the reagent shall be checked.

When the wool or silk content of a mixture exceeds 25 %, the method described in ISO 1833‑4 shall be used.

When the polyamide content of a mixture exceeds 25 %, the method described in ISO 1833‑7 shall be used.

It is also possible to analyse mixtures containing chlorofibres by using the test methods described in ISO 1833‑13 or ISO 1833‑21.

Oblast zaměření: Potravinářské produkty
Komise : CEN/TC 338 (Cereals and cereal products)
Původce: CEN
K připomínkám do: 15.03.2019
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This standard describes a method for the determination of the colour in durum wheat semolina and soft wheat flour by reflectance diffused colorimetry. The standard is suitable for industrial semolina and flour.

This method may be applicable to flours obtained from experimentally milled.