Hlavní oblasti

Oblast zaměření: Ropné produkty
Komise : CEN/TC 343 (Solid recovered fuels)
Původce: CEN
K připomínkám do: 6.04.2020
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This document provides principles and requirements for safe handling, treatment and storage of solid recovered fuels (SRF), prepared from non-hazardous waste, to be used for energy purposes. This document covers process stages from point of acceptance of material to point of delivery of SRF.

This document excludes fuels that are included in the scope of ISO/TC 238 Solid biofuels and ISO/TC 28 Petroleum products and related products of synthetic or biological origin.

It uses a risk-based approach to determine what safety measures should be considered.

Although unloading and loading of e.g. vessels, trains or trucks are included, the safety issues following the loading and transport itself are not.

Oblast zaměření: Pevná paliva
Komise : CEN/TC 335 (Solid Biofuels)
Původce: CEN
K připomínkám do: 7.04.2020
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This part of ISO 17225 determines the fuel quality classes and specifications of graded wood pellets for non-industrial and industrial use. This part of ISO 17225 covers only wood pellets produced from the following raw materials (see ISO 17225‑1, Table 1):

—    1.1 Forest, plantation and other virgin wood;

—    1.2 By-products and residues from wood processing industry;

—    1.3.1 Chemically untreated used wood.

Thermally treated biomass pellets (e.g. torrefied pellets) are not included in the scope of this part of ISO 17225. Torrefaction is a mild pre-treatment of biomass at a temperature between 200 °C to 300 °C.

Oblast zaměření: Pevná paliva
Komise : CEN/TC 335 (Solid Biofuels)
Původce: CEN
K připomínkám do: 7.04.2020
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This part of ISO 17225 determines the fuel quality classes and specifications of graded wood briquettes. This part of ISO 17225 covers only wood briquettes produced from the following raw materials (see ISO 17225‑1, Table 1):

—    1.1 Forest, plantation and other virgin wood

—    1.2 By-products and residues from wood processing industry

—    1.3.1 Chemically untreated used wood

NOTE       Thermally treated biomass briquettes (e.g. torrefied briquettes) are not included in the scope of this part of ISO 17225. Torrefaction is a mild pre-treatment of biomass at a temperature between 200 – 300 °C.

Komise : CEN/TC 310 (Advanced Manufacturing Technologies)
Původce: CEN
K připomínkám do: 7.04.2020
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This part of ISO 10218 specifies requirements and guidelines for the inherently safe design, protective measures and information for use of robots for an industrial environment. It describes basic hazards associated with robots and provides requirements to eliminate, or adequately reduce, the risks associated with these hazards.

This part of ISO 10218 does not address the robot as a complete machine. Noise emission is generally not considered a significant hazard of the robot alone, and consequently noise is excluded from the scope of this part of ISO 10218.

This part of ISO 10218 does not apply to undersea, defence, law enforcement, military and space robots, medical and healthcare, prosthetics and other aids for the physically impaired, service or consumer products, tele operated manipulators, and micro robots (displacement less than 1 mm).

NOTE 1: Requirements for robot systems, integration, and applications are covered in ISO 10218-2.

NOTE 2: Additional hazards can be created by specific applications (e.g. welding, laser cutting, machining). These system-related hazards need to be considered during robot system design. See ISO 10218-2.

Komise : CEN/TC 139 (Paints and varnishes)
Původce: CEN
K připomínkám do: 7.04.2020
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This document specifies general terms and definitions that are used in the context of rotational and oscillatory rheometry.

Other terms and definitions can be found in the other parts of the standards series where they are used.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 7.04.2020
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This document specifies the minimum requirements to be satisfied to ensure and demonstrate that proper provision has been made to minimize pain and distress, which can negatively affect the validity of the data. This document is for those who commission, design and perform testing or evaluate the data to assess the biocompatibility of materials intended for use in medical devices, or that of the medical devices themselves.

This document makes recommendations and offers guidance intended to facilitate further reductions in the overall number of animals used, refinement of test methods to reduce or eliminate pain or distress in animals, and the replacement of animal tests by other scientifically valid means not requiring animal tests.

This document applies to tests performed on living vertebrate animals, other than man, to establish the biocompatibility of materials or medical devices.

This document does not apply to tests performed on invertebrate animals and other lower forms; nor (other than with respect to provisions relating to species, source, health status, and care and accommodation) does it apply to testing performed on isolated tissues and organs taken from vertebrate animals that have been euthanized.

Oblast zaměření: Ovládání ohřívačů
Komise : CEN/TC 58 (Safety and control devices for burners and appliances burning gaseous or liquid fuels )
Původce: CEN
K připomínkám do: 7.04.2020
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This document specifies the safety, construction and performance requirements for electronic fuel/air ratio control system (ERC), electronic fuel/air ratio supervision system (ERS) and electronic fuel/air ratio trim system (ERT) intended for use with burners and appliances burning gaseous or liquid fuels. It also describes the test procedures for evaluating these requirements and specifies information necessary for installation and use.

This document is applicable to

—    closed loop fuel/air ratio control systems, see 3.101;

—    fuel/air ratio supervision systems, see 3.102;

—    closed loop fuel/air ratio trim systems, see 3.103;

and does not differentiate into classification by heat input.

NOTE 1       European Standards for burners, appliances or processes which use ERC, ERS or ERT can override the requirements of this document.

NOTE 2       Provisions for production control are not part of this document.

Oblast zaměření: Nádobí
Komise : CEN/TC 194 (Utensils in contact with food)
Původce: CEN
K připomínkám do: 7.04.2020
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This document specifies safety and performance requirements of domestic ceramic and glass ceramic cookware for use on top of a stove, cooker or hob.

This document envisages that oven top applications for ceramic utensils involves all or specific parts of the cooking operation for example the browning of meat, where the remainder of the cooking may be completed in an oven or on top of the stove.

NOTE          Requirements for suitability for use with induction hobs are in the process of being compiled.

Oblast zaměření: Nádobí
Komise : CEN/TC 194 (Utensils in contact with food)
Původce: CEN
K připomínkám do: 7.04.2020
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This document specifies safety and performance requirements for items of cookware for domestic use on top of a stove, cooker or hob. It is applicable to all cookware regardless of material or method of manufacture with the exceptions of those mentioned below. It is also applicable to cookware intended for use both “on top“ and “in oven“.

Hob types covered by this document are gas, electricity solid plate, electricity radiant ring, radiant plate in glass ceramic and induction plate in glass ceramic.

This document is not applicable to pressure cookers, stove top water kettles and coffee makers.

NOTE 1       Requirements for suitability for use in automatic dishwashers is under study by a specialist group and will be added by amendment when completed.

NOTE 2       The requirements for ceramic and glass ceramic are specified in part 2.

Oblast zaměření: Potravinářské produkty
Komise : CEN/TC 307 (Oilseeds, vegetable and animal fats and oils and their by-products - Methods of sampling and analysis)
Původce: CEN
K připomínkám do: 7.04.2020
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This document specifies a titrimetric method for the determination of acid value in light coloured Fatty Acid Methyl Esters, hereinafter referred as FAME.

It allows the determination of acid value within a range of 0,10 mg KOH/g to 1,00 mg KOH/g.

NOTE          For the purposes of this document, the terms “% (m/m)” and “% (V/V)” are used to represent respectively the mass fraction and the volume fraction.

WARNING — The use of this document can involve hazardous materials, operations and equipment. This document does not purport to address all of the safety problems associated with its use. It is the responsibility of users of this document to take appropriate measures to ensure the safety and health of personnel prior to the application of the standard, and to determine the applicability of any other restrictions for this purpose.

Komise : CEN/TC 227 (Road materials)
Původce: CEN
K připomínkám do: 7.04.2020
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Amendment

Oblast zaměření: Kovové a plastické kontejnery
Komise : CEN/TC 268 (Cryogenic vessels)
Původce: CEN
K připomínkám do: 7.04.2020
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This document defines the minimum requirements to ensure the interoperability of hydrogen refuelling points, including refuelling protocols that dispense gaseous hydrogen to road vehicles (e.g. Fuel Cell Electric Vehicles) that comply with legislation applicable to such vehicles.

The safety and performance requirements for the entire hydrogen fuelling station, addressed in accordance with existing relevant European and national legislation, are not included in this document.

NOTE          Guidance on considerations for hydrogen fuelling stations is provided in ISO 19880-1.

Komise : CEN/TC 206 (Biological evaluation of medical devices)
Původce: CEN
K připomínkám do: 8.04.2020
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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 induce skin sensitization.

This document includes:

—    details of in vivo sensitization test procedures;

—    key factors for the interpretation of the results.

NOTE       Instructions for the preparation of materials specifically in relation to the above tests are given in Annex A.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 12.04.2020
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This document specifies requirements and test methods for needle-based injection systems with automated functions (NIS-AUTO), including but not limited to:

a)    medicinal product preparation (e.g. reconstitution);

b)    needle preparation;

c)    needle hiding;

d)    priming;

e)    dose setting;

f)     needle insertion;

g)    injection depth control;

h)    injection of the medicinal product;

i)     recording;

j)     disabling the NIS-AUTO;

k)    needle retraction;

l)     needle shielding;

m)   needle removal.

This document does not cover remote communication from the NIS-AUTO.

Automated features not included in the list above shall be specified and tested in accordance with the principles of this document.

All references to "function" in this document are by definition to be construed as automated functions (see 3.2). This document does not apply to these functions if they are performed manually by the user.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 12.04.2020
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This document specifies requirements and test methods for Needle-Based Injection Systems (NISs) for single-patient use intended to deliver discrete volumes (bolus) of medicinal product, through needles or soft cannulas for intradermal, subcutaneous and/or intramuscular delivery, incorporating pre-filled or user-filled, replaceable or non-replaceable containers.

Stand-alone prefilled syringes defined by ISO 11040-8 are not covered by this document (see exclusions below). However, when the prefilled syringes are provided to the user with an integrated addition, certain portions of the ISO 11608 series apply as follows:

—    prefilled syringes that are provided to the user with an integrated electronic addition (e.g. electronic dose counter) are covered by relevant requirements of ISO 11608-4, but only to assess the function, feature or performance of the “addition” not the prefilled syringe;

—    prefilled syringes that are provided to the user with an integrated addition that provides an automated function (e.g. an automated inserter that inserts to a predetermined insertion depth or needle safety device) are covered by relevant requirements of ISO 11608-5, but only to assess the function, feature or performance of the “addition” (as integrated into the NIS) not the prefilled syringe.

It is important to note that other functions and characteristics of the prefilled syringe, such as dose accuracy, are subject to the requirements (delivered volume) in ISO 11040-8 and not this document, unless the addition impacts the delivery function (e.g. a mechanism that intends to restrict or stop the plunger movement, which would limit the dose delivered). In that case, the system is completely covered by this document and applicable requirements of the ISO 11608 series.

Excluded from the scope are:

—    stand-alone prefilled syringes defined by ISO 11040-8 (with noted exceptions above);

—    toxicity (biocompatibility) of materials that form the medicinal product contact surfaces of the primary container closure;

—    NISs that provide continuous delivery and require a delivery rate clinically specified in the medicinal product labelling or determined by a physician based on clinical relevance (i.e. medication efficacy) as would be the case with insulin patch pumps or traditional infusion pumps (e.g. IEC 60601-2-24, ISO 28620) associated with continuous delivery of medicinal products (e.g. insulin);

—    containers that can be refilled multiple times;

—    needle-free injectors;

—    requirements relating to methods or equipment associated with user filling of containers unless they are dedicated accessories;

—    NISs intended for dental use;

—    syringes and needles which are not intended for use in a NIS;

—    NISs intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).

NOTE       These exclusions might benefit from elements in this document but might not completely fulfil the basic safety and effectiveness of those products.

Oblast zaměření: Zemědělské stroje
Komise : CEN/TC 144 (Tractors and machinery for agriculture and forestry)
Původce: CEN
K připomínkám do: 12.04.2020
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This part of ISO 11680 gives safety requirements and measures for their verification for the design and construction of portable, hand-held, pole-mounted powered pruners (hereafter named “machine”), including extendable and telescopic machines, having an integral combustion engine as their power source. These machines use a power transmission shaft to transmit power to a cutting attachment consisting of a saw chain and guide bar, a reciprocating saw blade or a single-piece circular saw blade with a 205 mm maximum outside diameter. Methods for the elimination or reduction of hazards arising from the use of these machines and the type of information on safe working practices to be provided by the manufacturer are specified.

This part of ISO 11680 deals with all significant hazards, hazardous situations or hazardous events with the exception of electric shock from contact with overhead electric lines (apart from warnings and advice for inclusion in the instructions), relevant to these machines when they are used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer (see Annex A).

This part of ISO 11680 is applicable to portable, hand-held, pole-mounted powered pruners manufactured after its date of publication.

NOTE       Brush cutters with a circular saw blade are not included in the scope of this standard. Brush cutter requirements are outlined in ISO 11806-1.

Oblast zaměření: Zemědělské stroje
Komise : CEN/TC 144 (Tractors and machinery for agriculture and forestry)
Původce: CEN
K připomínkám do: 12.04.2020
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This part of ISO 11680 gives safety requirements and measures for their verification for the design and construction of portable, hand-held, pole-mounted powered pruners with a backpack power unit and using a power transmission shaft to transmit power to a cutting attachment consisting of a saw chain, a reciprocating saw blade or a single-piece circular saw blade (hereafter referred to as “machine”). Methods for the elimination or reduction of hazards arising from the use of these machines and the type of information on safe working practices to be provided by the manufacturer are specified.

This part of ISO 11680, together with the relevant sections of ISO 11680-1, deals with all significant hazards, hazardous situations or hazardous events with the exception of electric shock from contact with overhead electric lines (apart from warnings and advice for inclusion in the instructions) and whole-body vibration from the backpack power unit, relevant to these machines when they are used as intended and under conditions of misuse which are reasonably foreseeable by the manufacturer.

NOTE 1   A standardized test procedure for measuring whole-body vibration from the backpack power unit is presently not available.

NOTE 2   See Annex A for a list of significant hazards.

This part of ISO 11680 is applicable to portable, hand-held, pole-mounted powered pruners with backpack power unit manufactured after its date of publication.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 12.04.2020
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This document specifies requirements, test methods and compatibility requirements for single-use, double-ended, sterile needles used with needle-based injection systems (NISs) that fulfil the specifications of ISO 11608-1.

NOTE       Needles provided by the manufacturer integrated into the fluid path or container are covered in ISO 11608‑3, and hypodermic needles provided separately are covered in ISO 7864.

This document is not applicable to:

—    needles for dental use;

—    pre-filled syringe needles;

—    needles intended for different routes of administration (e.g. intravenous, intrathecal, intraocular).

Oblast zaměření: Nezařazeno
Komise : CEN/TC 205 (Non-active medical devices)
Původce: CEN
K připomínkám do: 12.04.2020
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This document specifies requirements and test methods for needle-based injection systems (NISs) containing electronics with or without software.

The needle-based injection system containing electronics can be single use, reusable, and/or rechargeable. It is intended to deliver medication to a patient by self-administration or by administration by one other operator (e.g. caregiver or health care provider).

This document applies to electronic accessories which are intended to be physically connected to a NIS or NIS-E during the NIS/NIS-E intended use.

NOTE       This document includes relevant requirements derived from IEC 60601 series.