Hlavní oblasti

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 26.06.2019
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This international standard provides dentists and forensic dental experts with an organized system of concepts to describe the distinctive characteristics of an individual’s mouth. The chosen system is based on a forensic approach of a mouth’s characteristics, with many concepts specifics to the identification domain that are not defined elsewhere in ISO dentistry vocabularies (e.g. “present tooth”).

The hierarchical structure of the standard is designed to describe attributes of a tooth, the mouth and a prosthesis/orthosis with increasing levels of discriminative characteristics (e.g. material characteristics, restored tooth surface…) and the possibility to connect any level of description of an attribute with the most comprehensive concept.

This standard is intended to be used for data exchange between antemortem and postmortem files, without any ambiguity on the terms used to describe an individual’s mouth.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 26.06.2019
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This document specifies requirements and test methods for cartridge syringes used in dentistry which are reusable syringes of the aspirating, non-aspirating and self-aspirating types using cartridges with dental local anaesthetics.

This document is not applicable to cartridge syringes having a mechanical-advantage action for creating high pressure.

This document specifies requirements for cartridge syringes with ISO metric thread sizes. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).

Oblast zaměření: Ocel
Komise : CEN/TC 342 (Steel tubes and fittings for steel tubes - Flexible metallic hoses, hose assemblies, bellows and expansion joints)
Původce: CEN
K připomínkám do: 29.06.2019
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This International Standard defines current terms concerning metal hoses, metal hose assemblies and component parts.

This International Standard applies to:

a)     Stripwound metal hoses and hose assemblies;

b)    Corrugated metal hoses and hose assemblies.

NOTE         These hoses may be used braided, covered or lined.

Oblast zaměření: Chirurgické implantáty
Komise : CEN/TC 285 (Non-active surgical implants)
Původce: CEN
K připomínkám do: 30.06.2019
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Part 2 of ISO 25539 specifies requirements for the evaluation of stent systems (vascular stents and delivery systems) and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to this standard. This standard should be considered as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants.

NOTE          Due to the variations in the design of implants covered by this part of ISO 25539 and in some cases due to the relatively recent development of some of these implants (e.g. absorbable stents, polymeric stents), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of this part of ISO 25539 will be necessary.

The scope of this part of ISO 25539 is applicable to vascular stents and vascular scaffolds (e.g. absorbable vascular scaffolds) used to treat vascular stenoses or other vascular abnormalities or pathologies. Some of the requirements are specific to endovascular treatment of arterial stenoses. Although uses of stent systems other than treatment of arterial stenoses (e.g. venous stenting) are within the scope of this standard, comprehensive requirements and testing are not described for these uses. Similarly, specific stent configurations (e.g. bifurcation stents) are within the scope, but comprehensive requirements and testing are not described for these devices.

Stents used in combination with an endovascular prosthesis to complete the treatment of a lesion, including bridging stents (e.g. stents placed in the renal arteries after deployment of a fenestrated endovascular prosthesis), are within the scope of this standard, but test methods are not described for the combination. The preclinical in vivo and clinical evaluations of these stents may be addressed with the evaluations of the associated endovascular prosthesis in accordance with ISO 25539-1.

Vascular stents that have surface modifications, such as drug and/or other coatings, are within the scope of this standard. Stents covered with materials that significantly modify the permeability of the uncovered stent (e.g. by covering the stent-free-surface area) are within the scope of ISO 25539-1. The stent design or intended use might dictate the need to address functional requirements identified in both ISO 25539-1 and this part of ISO 25539 (e.g. stents used in combination with endovascular prostheses, stents used to treat aortic aneurysms).

Balloons integral to the stent system are within the scope of this standard. This part of ISO 25539 provides requirements beyond the requirements of ISO 10555-4 Intravascular catheters — Sterile and single-use catheters, specific to the use of balloons with vascular stents.

This part of ISO 25539 is not applicable to procedures and devices used prior to the introduction of the vascular stent, such as balloon angioplasty devices.

Tacking devices intended to spot treat post-angioplasy dissections, coil supporting devices, and flow diverters are within the scope of this standard, but comprehensive requirements and testing are not described for these devices.

Although drug-eluting stents are within the scope of this standard, this standard is not comprehensive with respect to the drug-eluting properties of these devices.

NOTE          Vascular device-drug combination products are within the scope of ISO 12417-1 Cardiovascular implants and extracorporeal systems – Vascular device-drug combination products.

Although absorbable stents and stents with absorbable coatings are within the scope of this standard, this standard in not comprehensive with respect to the absorbable properties of these devices.

NOTE          Absorbable implants are within the scope of ISO/TS 17137 Cardiovascular implants and extracorporeal systems — Cardiovascular absorbable implants.

Although coated stents and coated stent systems are within the scope of this standard, this standard is not comprehensive with respect to coatings.

NOTE          Some coating properties are within the scope of ISO 17327-1 Non-active surgical implants — Implant coating — Part 1: General requirements.

This standard does not address the requirements for, and the evaluation of, viable tissues and non-viable biologic materials used in the construction of vascular stents.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 30.06.2019
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This document specifies the procedure for the assessment of medical devices and their constituent materials with regard to their potential to produce irritation. The tests are designed to predict and classify the irritation potential of medical devices, materials or their extracts according to ISO 10993‑1 and ISO 10993‑12.

This document includes:

—    pre-test considerations for irritation, including in silico and in vitro methods for dermal exposure;

—    details of in vitro and in vivo irritation test procedures;

—    key factors for the interpretation of the results.

Instructions are given in Annex A for the preparation of materials specifically in relation to the above tests. In Annex D several special in vivo irritation tests are described for application of medical devices in areas other than skin. In addition, Annex E provides information for conducting human skin irritation testing.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 30.06.2019
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This document specifies requirements and gives guidance on the procedures to be followed in the preparation of samples and the selection of reference materials for medical device testing in biological test systems onlyin accordance with one or more parts of ISO 10993. Specifically, this document addresses the following:

—    test sample selection;

—    selection of representative portions from a medical device;

—    test sample preparation;

—    experimental controls;

—    selection of, and requirements, for reference materials;

—    preparation of extracts.

This document is not applicable to live cells, but can be relevant to the material or medical device components of combination products containing live cells.

Komise : CEN/TC 148 (Continuous handling equipment and systems. Safety)
Původce: CEN
K připomínkám do: 1.07.2019
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This document deals with the technical requirements to minimize the hazards listed in Annex F. These hazards can arise during the operation and maintenance of continuous handling equipment and systems when carried out in accordance with the specifications given by the manufacturer or his authorized representative. This document deals with safety related technical verification during commissioning.

1.2     This document applies to mechanical handling devices as defined in Clause 3, singly or combined to form a conveyor system, and designed exclusively for moving unit loads continuously on a predefined route from the loading to the unloading points, possibly with varying speed or cyclically. In general, it also applies to conveyors which are built into machines or attached to machines.

1.3     Safety requirements and/or measures in this document apply to equipment used in all environments. However, additional risk assessments and safety measures need to be considered for uses in severe conditions, e.g.

—    freezer applications,

—    high temperatures,

—    corrosive environments,

—    strong magnetic fields,

—    potentially explosive atmospheres,

—    radioactive conditions and loads the nature of which could lead to a dangerous situation (e.g. molten metal, acids/bases, especially brittle loads, explosives),

—    operation on ships and earthquake effects and

—    contact with foodstuff.

1.4     This document deals with the technical requirements for electromagnetic compatibility (EMC).

1.5     This document does not cover hazards during decommissioning. It also does not cover operation in environments where the electromagnetic disturbances are outside the range of those specified in EN 61000‑6‑2:2016.

This document does not apply to conveying equipment and systems used underground or in public areas and to aircraft ground support equipment. In public areas only baggage carousels and check-in conveyors for airports are dealt with in this document.

NOTE          Aircraft ground support equipment is covered by the standards of CEN/TC 274.

1.6     This document is not applicable to continuous handling equipment and systems manufactured before the date of its publication.

Oblast zaměření: Tlakové nádoby
Komise : CEN/TC 54 (Unfired pressure vessels)
Původce: CEN
K připomínkám do: 1.07.2019
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Amendment

Komise : CEN/TC 139 (Paints and varnishes)
Původce: CEN
K připomínkám do: 1.07.2019
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This part of ISO 8502 describes a field method for the assessment of the surface density of various water-soluble salts on steel surfaces, before and/or after surface preparation, by conductometric determination. The individual surface densities of the salt composition like chlorides, sulphates, sodium, etc, cannot be determined by this method. This method assesses only contaminants that will form an electrolyte (ions) when in contact with water. These represent the greater part of the contaminants.

Komise : CEN/TC 139 (Paints and varnishes)
Původce: CEN
K připomínkám do: 1.07.2019
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This part of ISO 8502 describes a method of extracting, for analysis, water soluble contaminants from a surface by use of flexible cells in the form of adhesive patches or sleeves which can be attached to any surface, regardless of its shape (flat or curved) and its orientation (facing in any direction, including downwards).

The method described is suitable for use in the field to determine the presence of water soluble contaminants before painting or a similar treatment.

This part of ISO 8502 does not cover the subsequent analysis of the contaminants that have been dissolved off. Methods of analysis suitable for field use are described in other parts of ISO 8502.

NOTE          The extraction method might give a false negative or not take all the water-soluble material off the surface because of: (1) Soluble materials hiding in the crevices or under folds of metal; (2) Soluble materials under corrosion layers, passivation layers produced by corrosion inhibitors, oil, grease, or other non-visible thin films.

Oblast zaměření: Tlakové nádoby
Komise : CEN/TC 54 (Unfired pressure vessels)
Původce: CEN
K připomínkám do: 1.07.2019
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This Part 12 of EN 13445 series specifies requirements for unfired pressure vessels and their parts made of copper and copper alloys (see 5.2) in addition to the general requirements for unfired pressure vessels in EN 13445‑1:2014 to EN 13445‑5:2014.

NOTE 1       Cast materials are not included in this version. Details regarding cast materials will be subject to an amendment to or a revision of EN 13445 series.

NOTE 2       Soldered connections are presently not considered.

Komise : CEN/TC 139 (Paints and varnishes)
Původce: CEN
K připomínkám do: 1.07.2019
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This part of ISO 8501 specifies a series of preparation grades for steel surfaces after removal/partial removal of water-soluble contaminants, rust, previous paint coatings and other foreign matter by high-pressure water jetting. The various grades are defined by written descriptions together with photographs that are representative examples within the tolerances for each grade as described in words. In addition, this part of ISO 8501 specifies both initial surface conditions and after-cleaning flash rust grades, also defined by written descriptions together with representative photographic examples.

NOTE 1       Examples of foreign matter, other than paint residues, are salt, grime, dirt, mill scale, oil, grease and marine growth, e.g. algae.

This part of ISO 8501 relates the cleanliness of the surface to its visual appearance. In many instances, this is sufficient for the purpose but, for coatings likely to be exposed to severe environments, such as water immersion and continuous condensation conditions, consideration should be given to testing for soluble salts and other invisible contaminants on the visually clean surface by the physical and chemical methods which form the subjects of the various parts of ISO 8502.

The roughness characteristics of the surface should also be considered by reference to ISO 8503, although it must be noted that preparation by high- pressure water jetting does not create a profile or significantly change an existing profile.

Oblast zaměření: Stavební konstrukce
Komise : CEN/TC 288 (Execution of special geotechnical works)
Původce: CEN
K připomínkám do: 1.07.2019
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This document is applicable to the execution, testing and monitoring of geotechnical grouting work.

Grouting for geotechnical purposes (geotechnical grouting) is a process in which the remote placement of a pumpable material in the ground is indirectly controlled by adjusting its rheological characteristics and by the manipulation of the placement parameters (pressure, volume and the flow rate).

The following principles and methods of geotechnical grouting are covered by this document:

•      displacement grouting (compaction and compensation grouting);

•      grouting without displacement of the host material (permeation, fissure/rock grouting, bulk filling).

The principal objectives of geotechnical grouting are:

•      the modification of the hydraulic/hydrogeological characteristics the ground;

•      the modification of the mechanical properties of the ground;

•      the filling of natural cavities, mine workings, voids adjacent to structures;

•      inducing displacement to compensate for ground loss or to stabilize and lift footings, slabs and pavements.

Specialized grouting activities, generally associated with structural and/or emergency works, are not covered by this document.

The execution, testing and monitoring of jet grouting work is not covered by this document and is covered by EN 12716.

Komise : IEC/TC 76 (Optical radiation safety and laser equipment)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 2.07.2019
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This document provides requirements and specific guidance for the safe operation and maintenance of optical fibre communication systems (OFCSs). In these systems optical power is possibly be accessible outside the confines of the transmitting equipment and/or at great distance from the optical source.

This document requires the assessment of hazard level at each accessible location of the OFCS as a replacement for product classification according to IEC 60825-1. It applies to the installed OFCS as an engineered, end-to-end assembly for the generation, transfer and receipt of optical radiation arising from lasers, light-emitting diodes (LEDs) or optical amplifiers, in which the transference is by means of optical fibre for communication and/or control purposes.

Individual components and subassemblies that fall under the definition of a laser product are subject to the applicable subclause(s) of IEC 60825-1. This document is applicable to individual components and subassemblies intended to be installed within OFCSs.

This document does not apply to optical fibre systems primarily designed to transmit optical power for applications such as material processing or medical treatment.

Throughout this document, a reference to ‘laser’ is taken to include LEDs and optical amplifiers.

In addition to the hazards resulting from laser radiation, OFCSs possibly give rise to other hazards, such as fire.

This document does not address safety issues associated with explosion or fire with respect to OFCSs deployed in explosive atmospheres.

NOTE The hazard presented by optical radiation emerging from a fibre is determined by the wavelength and power emerging from the fibre and also by the optical characteristics of the fibre itself (see Annex A).

The objective of this document is to:

–   protect people from optical radiation emitted by OFCSs;

–   provide requirements for manufacturers, installation organisations, service organisations and operating organisations in order to establish procedures and supply information so that proper precautions can be adopted;

–   ensure adequate warnings are provided to individuals regarding the potential hazards associated with OFCSs through the use of signs, labels and instructions.

Annex A gives a more detailed rationale for this document.

The safety of an OFCS depends to a significant degree on the characteristics of the equipment forming that system. Depending on the characteristics of the equipment, it is necessary to mark relevant safety information on the product or include it within the instructions for use.

Where required by the level of potential hazard, this document places the responsibility for the safe deployment and use of these systems on the installer or end-user / operating organisation or both. This document places the responsibility for adherence to safety instructions during installation and service operations on the installation organisation and service organisation as appropriate, and operation and maintenance functions on the end-user or operating organisation. It is recognised that the user of this document may possibly fall into one or more of the aforementioned categories of manufacturer, installation organisation, end-user or operating organisation.

Komise : IEC/SC 61D (Appliances for air-conditioning for household and similar purposes)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 2.07.2019
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This clause of Part 1 is replaced by the following:

This International Standard deals with the safety of electrical recovery and/or recycle equipment to recover and/or recycle refrigerant from air conditioning and refrigeration equipment incorporating open drive or motor-compressors, their maximum rated voltages being not more than 300 V for single phase appliances and 600 V for all other equipment.

Appliances not intended for normal household use but which nevertheless may be a source of danger to the public, such as appliances intended to be used by service personnel in shops, in light industry and on farms, are within the scope of this standard.

The appliances referenced above may consist of one or more factory made assemblies. If provided in more than one assembly, the separate assemblies are to be used together, and the requirements are based on the use of matched assemblies.

NOTE 101 A definition of “sealed motor-compressor” is given in IEC 60335-2-34.

NOTE 102 Requirements for refrigeration safety are covered by ISO 5149-2.

NOTE 103 For appliances using flammable refrigerants, additional requirements are under consideration.

NOTE 104 Attention is drawn to the fact that

for appliances intended to be used in vehicles or on board ships or aircraft, additional requirements may be necessary;

for appliances subjected to pressure, additional requirements may be necessary;

in many countries additional requirements are specified by the national health authorities, the national authorities responsible for the protection of labour, national water supply authorities and similar authorities.

NOTE 105 This standard does not apply to

appliances intended to be used in locations where special conditions prevail, such as the presence of a corrosive or explosive atmosphere (dust, vapour or gas).

Komise : IEC/SC 61C (Safety of refrigeration appliances for household and commercial use)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 2.07.2019
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This clause of Part 1 is replaced by the following.

This International Standard deals with the safety of sealed (hermetic and semi-hermetic type) motor-compressors, their protection and control systems, if any, which are intended for use in equipment for household and similar purposes and which conform with the standards applicable to such equipment. It applies to motor-compressors tested separately, under the most severe conditions that may be expected to occur in normal use, their rated voltage being not more than 250 V for single-phase motor-compressors and 600 V for other motor-compressors.

This standard also covers

multi-speed motor-compressors, that are motor-compressors, the speed of which can be set to different values;

variable capacity motor-compressors that are motor-compressors where the capacity of the compressor is controlled at fixed speeds.

NOTE 101 Examples of equipment which contain motor-compressors are

tumble dryers (IEC 60335-2-11);

–   refrigerators, food freezers and ice-cream appliances (IEC 60335-2-24);

–   air-conditioners, electric heat pumps and dehumidifiers (IEC 60335-2-40);

–   commercial dispensing appliances and vending machines (IEC 60335-2-75);

commercial refrigerating appliances and ice-makers (IEC 60335-2-89);

climatic and environmental testing and other temperature conditioning equipment (IEC 61010-2-012)

–   factory-built assemblies for transferring heat in applications for refrigerating, air-conditioning or heating purposes or a combination of such purposes.

This standard does not supersede the requirements of standards relevant to the particular appliance in which the motor-compressor is used. However, if the motor-compressor type used complies with this standard, the tests for the motor-compressor specified in the particular appliance standard may not need to be made in the particular appliance or assembly. If the motor-compressor control system is associated with the particular appliance control system, additional tests may be necessary on the final appliance.

So far as is practical, this standard deals with the common hazards presented by motor-compressors used in appliances which are encountered by all persons in and around the home. However, it does not in general take into account

the use of appliances by young children or infirm persons without supervision;

playing with the appliances by young children.

NOTE 102 Attention is drawn to the fact that

–   for motor-compressors intended to be used in appliances in vehicles or on board ships, additional require­ments may be necessary;

–   in many countries, additional requirements are specified by the national health authorities, the national authorities responsible for the protection of labour and similar authorities.

NOTE 103 This standard does not apply to

–   motor-compressors designed exclusively for industrial purposes;

–   motor-compressors used in appliances intended to be used in locations where special conditions prevail, such as the presence of a corrosive or explosive atmosphere (dust, vapour or gas).

NOTE 104 If motor-compressors for refrigerant R-744 used in appliances with a transcritical refrigeration system are equipped with pressure relief devices, compliance with the requirements for these devices is checked during the tests on the final appliance.

Oblast zaměření: Vodiče pro vinutí
Komise : IEC/TC 55 (Winding wires)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 2.07.2019
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This part of IEC 60317 specifies general requirements of glass-fibre wound, resin or varnish impregnated, bare or enamelled rectangular copper wire.

The range of nominal conductor dimensions is given in subclause 4.1 and the relevant specification sheet.

Oblast zaměření: Vodiče pro vinutí
Komise : IEC/TC 55 (Winding wires)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 2.07.2019
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This part of IEC 60317 specifies the general requirements of enamelled rectangular copper winding wires.

The range of nominal conductor dimensions is given in 4.1 and the relevant specification sheet.

Oblast zaměření: Stomatologie
Komise : CEN/TC 55 (Dentistry)
Původce: CEN
K připomínkám do: 2.07.2019
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This document specifies requirements, test methods, instructions for use and marking for multifunction handpieces (colloquially called “syringes”) intended to be used in the oral cavity of the patient. The multifunction handpieces are connected to dental units and provide the user with water, air and spray for treatment purposes. Some multifunction handpieces provide also illumination of the situs.

This document does not apply to dental handpieces and motors, dental turbines, intraoral cameras, contra angels, dental polymerisation lamps, powered scalers, powder jet handpieces, prophy handpieces, suction cannulas and saliva ejectors.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 438 (Additive Manufacturing)
Původce: CEN
K připomínkám do: 2.07.2019
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This document specifies requirements for the qualification of operators of metal powder bed fusion machines and equipment for additive manufacturing.

This document is applicable if the operator qualification testing is required by contract or by application standards.