Ämnesområden

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 18 jul 2018
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This document specifies requirements that are applicable to those ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat bradyarrhythmias and devices that provide therapies for cardiac resynchronization.

The tests that are specified in this document are type tests, and are to be carried out on samples of a device to show compliance.

This document was designed for Bradyarrhythmia PULSE generators used with endocardial or epicardial LEADS. At the time of this edition, the authors recognized the emergence of leadless technologies for which adaptations of this part will be required. Such adaptations are left to the discretion of MANUFACTURERS incorporating these technologies.

This document is also applicable to some non-implantable parts and ACCESSORIES of the devices (see NOTE 1).

The electrical characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD are determined either by the appropriate method detailed in this particular standard or by any other method demonstrated to have an accuracy equal to, or better than, the method specified. In case of dispute, the method detailed in this particular standard applies.

Any features of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat tachyarrhythmias are covered by ISO 14708-6.

NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE can in fact be a single device, a combination of devices, or a combination of a device or devices and one or more ACCESSORIES. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and ACCESSORIES if they could affect the safety or performance of the implantable device.

NOTE 2 In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

Kommittébeteckning: SIS/TK 340 (Implantat och biologisk säkerhet)
Källa: CEN
Svarsdatum: den 18 jul 2018
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This document specifies requirements that are applicable to IMPLANTABLE CARDIOVERTER DEFIBRILLATORS AND CRT-DS and the functions of ACTIVE IMPLANTABLE MEDICAL DEVICES intended to treat tachyarrhythmia.

The tests that are specified in ISO 14708 are type tests and are to be carried out on samples of a device to show compliance.

This document was designed for tachyarrhythmia PULSE generators used with either endocardial or epicardial LEADs. At the time of this edition, the authors recognized the emergence of technologies that do not use ENDOCARDIAL or EPICARDIAL LEADS for which adaptations of this part will be required. Such adaptations are left to the discretion of MANUFACTURERS incorporating these technologies.

This document is also applicable to some non-implantable parts and accessories of the devices (see Note 1).

The characteristics of the IMPLANTABLE PULSE GENERATOR or LEAD shall be determined by either theappropriate method detailed in this document or by any other method demonstrated to have accuracy equal to, or better than, the method specified. In the case of dispute, the method detailed in this document shall apply.

Any aspect of an ACTIVE IMPLANTABLE MEDICAL DEVICE intended to treat bradyarrhythmias or cardiac resynchronization is covered by ISO 14708-2.

NOTE 1 The device that is commonly referred to as an ACTIVE IMPLANTABLE MEDICAL DEVICE might in fact be a single device, a combination of devices, or a combination of a device or devices and one or more accessories. Not all of these parts are required to be either partially or totally implantable, but there is a need to specify some requirements of non-implantable parts and accessories if they could affect the safety or performance of the implantable device.

NOTE 2 The terminology used in this European Standard is intended to be consistent with the terminology of Directive 90/385/EEC.

NOTE 3 In this document, terms printed in small capital letters are used as defined in Clause 3. Where a defined term is used as a qualifier in another term, it is not printed in small capital letters unless the concept thus qualified is also defined.

NOTE 4 Particular requirements for congestive heart failure devices are under consideration. These types of devices are not covered by this document.

Kommittébeteckning: SIS/TK 535 (Karaktärisering av avfall, mark och slam)
Källa: ISO
Svarsdatum: den 18 jul 2018
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This standard describes a method to compare the quality of soils by determining the fatty acid composition of the leaves of plant species grown on these soils.

Because plant fatty acid composition can vary as functions of climatic conditions, the areas to compare must share the same climatic conditions (humidity, temperature, sunlight).

This method does not make it possible to determine an optimal value of the Omega-3 index, and therefore cannot be used to determine the intrinsic quality of a soil from a specific area (regard as homogeneous). The method can be only used to compare the quality of soils between various areas.

This method is applicable to:

— soils from contaminated sites;

— amended soils;

— soils after remediation;

— soil with waste products (e.g. slurry, manure, sludge or composts).

The Omega-3 index being an early indicator, its measurement is not relevant when a strong visual phenotype (highly reduced biomass, high leaf chlorosis…) is detected for plants having grown on one area, and not detected on another area.

Alternatively, the quality of soils can be assessed by determining Omega-3 index of Lactuca sativa seedlings grown on these soils under controlled conditions (i.e. phytotronic chamber) and by comparing it to that obtained on control soils (see Annex A).

Ämnesområden: Kylsystem. Smörjsystem
Kommittébeteckning: SIS/TK 220 (Motorer i bilar)
Källa: ISO
Svarsdatum: den 18 jul 2018
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This specification describes the methodology for measurement of heat transfer and pressure drop of liquid cooled Engine EGR coolers in internal combustion engines for road vehicles. The principles of this specification are valid for clean and fouled EGR coolers. Additional efforts have to be taken into account to guarantee comparable measurement results for fouled EGR coolers. These additional efforts have to be agreed between parties concerned.

Ämnesområden: Huvudskydd
Kommittébeteckning: SIS/TK 399 (Ögonskydd)
Källa: CEN
Svarsdatum: den 18 jul 2018
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This document specifies general requirements for eye and face protectors. These protectors are intended to provide protection for the eyes and faces of persons against common occupational hazards such as impacts from flying particles and fragments, optical radiation, dusts, splashing materials, molten metals, heat, flame, hot solids, harmful gases, vapours and aerosols.

Additional requirements for eye and face protectors used during welding and related techniques and for mesh protectors are given in ISO 16321-2 and ISO 16321-3.

This document applies to all afocal (plano) and prescription lens protectors and components.

This document also applies to those products of eye and face protection used for occupational-type tasks but not performed as part of an occupation, e.g. "do-it-yourself".

This document does not apply to:

— Protectors specifically intended for protection against sunlight for which ISO 12312 series applies;

— protectors for medically prescribed applications (not occupational); e.g. eye protection for severe dry eye, tints prescribed for medical conditions;

— protectors intended to control exposure of the eyes of patients during diagnosis or treatment (e.g. ISO/DTR 22463);

— protectors for use during medical or e.g. aesthetic applications, e.g. intense light sources (ILS) for which ISO 12609 series applies;

— protectors specifically intended for sports for which ISO 18527 series applies;

— laser protectors for which ISO 19818 applies;

— face protectors intended for live-working to protect against short-circuit electric arcs for which IEC 62819 applies;

— protectors intended to protect against ionizing radiation, e.g. X-rays, for which IEC 61331-3 applies.

Ämnesområden: Huvudskydd
Kommittébeteckning: SIS/TK 399 (Ögonskydd)
Källa: CEN
Svarsdatum: den 18 jul 2018
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This document specifies additional material, design, performance and marking requirements for eye and face protectors designed to provide protection for the eyes and faces of persons against occupational hazards during welding and related techniques, such as optical radiation, impacts from flying particles and fragments, and hot solids. The other applicable requirements for welding protectors are given in ISO 16321-1.

This document also applies to those products of eye and face protection used for occupational-type tasks but not performed as part of an occupation, e.g. "do-it-yourself".

Ämnesområden: Huvudskydd
Kommittébeteckning: SIS/TK 399 (Ögonskydd)
Källa: CEN
Svarsdatum: den 18 jul 2018
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This document specifies additional material, design, performance and marking requirements for mesh protectors designed to provide protection for the eyes and faces of persons against mechanical hazards such as impacts from flying particles and fragments.

The other applicable requirements for mesh protectors and the frames/mountings to which they are intended to be fitted are given in ISO 16321-1.

This document is not applicable to protectors for use against liquid splash (including molten metal), hot solid risks, electrical hazards, infrared and ultraviolet radiation. For protection against these hazards suitable additional or alternative protectors according ISO 16321-1 will be needed.

This document does not apply to mesh protectors used in sports such as fencing.

Ämnesområden: Industritruckar
Kommittébeteckning: SIS/TK 221 (Industritruckar)
Källa: CEN
Svarsdatum: den 18 jul 2018
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This document specifies the additional safety requirements and means of verification for rough-terrain variable-reach trucks (hereafter referred to as trucks) designed and intended for handling suspended loads which can swing freely in one or more directions. It is applicable to trucks covered by EN 1459-1 and EN 1459-2.

This document does not apply to:

— the lifting of suspended loads which by design of the load or the lifting attachments does not allow the load to swing freely in any direction;

— the handling of flexible intermediate bulk containers, as defined in ISO 21898, carried under the forks of the truck;

— any attachments/means used for lifting personnel;

— lifting accessories not included as part of the lifting attachment;

— freight container handling trucks.

This document deals with significant hazards, hazardous situations or hazardous events relevant to trucks handling a freely suspended load, when they are used as intended by the manufacturer.

This document is not applicable to rough-terrain variable-reach trucks fitted with a lifting attachment for handling suspended loads manufactured before the date of its publication.

Kommittébeteckning: SIS/TK 170 (Luftbehandlingsteknik)
Källa: CEN
Svarsdatum: den 18 jul 2018
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This international standard deals with the classification of fan efficiency for all fan types driven by motors of nominal rating 0.125kW and above. This standard may be used by legislators or regulatory bodies for defining future energy saving targets. This applies to the fan (driven) only but not to the system (finished Original Equipment Manufacturer’s product, e.g. box fans and roof fans or ventilation system) in which it is installed.

Ämnesområden: Lim
Kommittébeteckning: SIS/TK 162 (Lim och limningsteknik)
Källa: CEN
Svarsdatum: den 20 jul 2018
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This International Standard specifies a test method that measures the dimensional changes of a plastic or rubber floor or wall covering bonded to a given substrate after accelerated ageing. The term "wall covering" does not include any type of wallpaper.

Ämnesområden: Lim
Kommittébeteckning: SIS/TK 162 (Lim och limningsteknik)
Källa: CEN
Svarsdatum: den 20 jul 2018
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This International Standard specifies a test method to measure the dimensional changes of a linoleum floorcovering whilst being adhered to a glass substrate. This method is to be used in conjunction with other test methods and not used solely to determine the suitability of a particular adhesive/linoleum combination.

Ämnesområden: Lim
Kommittébeteckning: SIS/TK 162 (Lim och limningsteknik)
Källa: CEN
Svarsdatum: den 20 jul 2018
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This International Standard specifies a test method to measure the adhesion of a resilient or textile floor covering or wall covering bonded to a given substrate under shear forces. The term "wall covering" does not include any type of wallpaper.

Ämnesområden: Lim
Kommittébeteckning: SIS/TK 162 (Lim och limningsteknik)
Källa: CEN
Svarsdatum: den 20 jul 2018
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This International Standard specifies a test method to measure the adhesion of a resilient or textile floor covering or wall covering bonded to a given substrate under peel forces. The term "wall covering" does not include any type of wallpaper.

Ämnesområden: Lim
Kommittébeteckning: SIS/TK 162 (Lim och limningsteknik)
Källa: ISO
Svarsdatum: den 20 jul 2018
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This International Standard specifies a method for evaluating the adhesion of elastic adhesives and sealants (with a minimum elongation at break of 100 % and a modulus of elasticity of maximum 10 MPa1) on various substrates. In this way, the effect of various coatings or the surface pre-treatments of the substrate materials on the adhesion can be compared. It can also be used to evaluate the influence of pre-treatment, substrate and adhesive on the long term durability of adhesively bonded joints and seals. An adhesion test according to this standard can also be recommended for process monitoring and quality assurance accompanying production.

Ämnesområden: Fleroperationsmaskiner
Kommittébeteckning: SIS/TK 491 (Uppmätning av verktygsmaskiner)
Källa: ISO
Svarsdatum: den 21 jul 2018
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This document specifies the requirements of anti-collision devices and systems installed on tower cranes (as defined in EN 14439) to avoid the risks of collision between several cranes in service, between a crane in use and fixed obstacles, and over prohibited zones.

It also specifies the requirements for working range limiting devices.

Anti-collision devices and systems and working range limiting devices according to this document are safety components.

It applies to anti-collision devices manufactured after the publication of this document.

NOTE For anti-collision systems used to avoid the risk of collision with power lines, additional requirements might be necessary.

This document defines the safety characteristics and requirements of anti-collision devices and systems intended for installation on self-erecting tower cranes and tower cranes erected from parts.

In particular:

— performance level;

— information to be provided by the sensors installed on the crane;

— operation, particularly in the event of failure, override and free jib slewing states of a crane;

— type of communication between devices;

— information for the crane operator and outside indicator.

It also specifies the requirements for marking the device or the system and the content of the instructions for use.

The significant hazards covered by this document are identified in Clause 4.

This document is not applicable to anti-collision devices and systems which are manufactured before the date of publication by CEN of this document.

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 23 jul 2018
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This European Standard specifies a test method and the minimum requirements for bactericidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use products - with water. Products can only be tested at a concentration of 80 % or less, as some dilution is always produced by adding the test organisms and interfering substance.

This document applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included:

a) processing, distribution and retailing of:

1) food of animal origin:

— milk and milk products;

— meat and meat products;

— fish, seafood, and related products;

— eggs and egg products;

— animal feeds;

— etc.

2) food of vegetable origin:

— beverages;

— fruits, vegetables and derivatives (including sugar, distillery, etc.);

— flour, milling and baking;

— animal feeds;

— etc.

b) institutional and domestic areas:

— catering establishments;

— public areas;

— public transports;

— schools;

— nurseries;

— shops;

— sports rooms;

— waste containers (bins, etc.);

— hotels;

— dwellings;

— clinically non sensitive areas of hospitals;

— offices;

— etc.

c) other industrial areas:

— packaging material;

— biotechnology (yeast, proteins, enzymes, etc.);

— pharmaceutical;

— cosmetics and toiletries;

— textiles;

— space industry, computer industry;

— etc.

EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2 This method corresponds to a phase 2 step 1 test.

 

Kommittébeteckning: SIS/TK 349 (Rengöring, desinfektion och sterilisering)
Källa: CEN
Svarsdatum: den 23 jul 2018
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This document specifies a test method and the minimum requirements for fungicidal or yeasticidal activity of chemical disinfectant and antiseptic products that form a homogeneous, physically stable preparation when diluted with hard water or - in the case of ready-to-use-products - with water. Products can only be tested at a concentration of 80 % or less as some dilution is always produced by adding the test organisms and interfering substance.

This document applies to products that are used in food, industrial, domestic and institutional areas excluding areas and situations where disinfection is medically indicated and excluding products used on living tissues except those for hand hygiene in the above considered areas. The following areas are at least included:

a) processing, distribution and retailing of:

1) food of animal origin:  
— milk and milk products;  
— meat and meat products;  
— fish, seafood, and related products;  
— eggs and egg products;  
— animal feeds;  
— etc.

2) food of vegetable origin:
— beverages;
— fruits, vegetables and derivatives (including sugar, distillery ...);
— flour, milling and baking;
— animal feeds;
— etc.

b) institutional and domestic areas:
— catering establishments;
— public areas;
— public transports;
— schools;
— nurseries;
— shops;
— sports rooms;
— waste containers (bins ...);
— hotels;
— dwellings;
— clinically non-sensitive areas of hospitals;
— offices;
— etc.

c) other industrial areas:
— packaging material;
— biotechnology (yeast, proteins, enzymes, ...);
— pharmaceutical;
— cosmetics and toiletries;
— textiles;
— space industry, computer industry;
— etc.

EN 14885 specifies in detail the relationship of the various tests to one another and to "use recommendations".

NOTE 1 The method described is intended to determine the activity of commercial formulations or active substances under the conditions in which they are used.

NOTE 2 This method corresponds to a phase 2 step 1 test.

Ämnesområden: Huvudskydd
Kommittébeteckning: SIS/TK 399 (Ögonskydd)
Källa: CEN
Svarsdatum: den 23 jul 2018
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This document specifies the reference test methods for determining the spherical, cylindrical, and prismatic refractive properties of unmounted and mounted plano lenses (non-corrective lenses) for eye and face protectors.

This document does not apply to any eye and face protection requirement standards for which other test methods are specified.

Other test methods may be used if shown to be equivalent.

Ämnesområden: Huvudskydd
Kommittébeteckning: SIS/TK 399 (Ögonskydd)
Källa: CEN
Svarsdatum: den 23 jul 2018
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This document specifies the reference test methods for determining the physical optical properties of personal eye and face protectors.

This document does not apply to any eye and face protection requirements standards for which other test methods are specified.

Other test methods may be used provided they have been shown to be equivalent.

Ämnesområden: Huvudskydd
Kommittébeteckning: SIS/TK 399 (Ögonskydd)
Källa: CEN
Svarsdatum: den 23 jul 2018
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This document specifies the reference test methods for determining the physical and mechanical properties of protectors.

This document does not apply to any eye and face protection requirements standards for which other test methods are specified.

Other test methods may be used if shown to be equivalent.