Hlavní oblasti

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 20.11.2019
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IEC 60601-1:2005+Amendment 1:2012, 1.1 is replaced by:

This document is applicable to the basic safety and essential performance of sleep apnoea breathing therapy equipment, hereafter referred to as ME equipment, intended to alleviate the symptoms of patients who suffer from obstructive sleep apnoea by delivering a therapeutic breathing pressure to the respiratory tract of the patient. Sleep apnoea breathing therapy equipment is intended for use in the home healthcare environment by lay operators as well as in professional healthcare institutions.

Sleep apnoea breathing therapy equipment is not considered to utilize physiologic closed-loop-control system unless it uses a physiological patient variable to adjust the therapy settings.

This document excludes sleep apnoea breathing therapy equipment intended for use with neonates.

This document is applicable to ME equipment or an ME system intended for those patients who are not dependent on mechanical ventilation.

This document is not applicable to ME equipment or an ME system intended for those patients who are dependent on mechanical ventilation such as patients with central sleep apnoea.

This document is also applicable to those accessories intended by their manufacturer to be connected to sleep apnoea breathing therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the sleep apnoea breathing therapy equipment.

Masks and application accessories intended for use during sleep apnoea breathing therapy are additionally addressed by ISO 17510. Refer to Figure AA.1 for items covered further under this document.

If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant.

Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in 7.2.13 and 8.4.1 of the general standard.

NOTE     See also 4.2 of the General Standard.

This document is not applicable to high-frequency jet ventilators (HFJVs) or high-frequency oscillatory ventilators (HFOVs) [1], which are given in ISO 80601-2-87 [3].  

This document does not specify the requirements for ventilators or accessories intended for critical care ventilators for ventilator-dependent patients, which are given in ISO 80601‑2‑12. [4]

This document does not specify the requirements for ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13. [5]

This document does not specify the requirements for ventilators or accessories intended for home care ventilators for ventilator-dependent patients, which are given in ISO 80601-2-72. [6]

This document does not specify the requirements for ventilators or accessories intended for emergency and transport, which are given in ISO 10651-3[1]). [7]

This document does not specify the requirements for ventilators or accessories intended for home-care ventilatory support, which are given in ISO 80601-2-79 [8] and ISO 80601‑2‑80.

This document is a particular standard in the IEC 60601-1 and ISO/IEC 80601 series of standards.

 

[1])    In the future, this standard is expected to be harmonized with the IEC 60601-1:2005 at which time it will be replaced by ISO 80601-2-xx.

Oblast zaměření: Nezařazeno
Komise : CEN/TC 438 (Additive Manufacturing)
Původce: CEN
K připomínkám do: 20.11.2019
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This document provides specifications and illustrations for the positioning and orientation of parts with regards with coordinate systems and testing methodologies for additive manufacturing (AM) technologies in an effort to standardize the method of representation used by AM users, producers, researchers, educators, press/media, and others, particularly when reporting results from testing of parts made on AM systems. Specifications included cover coordinate systems and the location and orientation of parts. It is intended, where possible, to be compliant with the principles of ISO 841 and to clarify the specific adaptation of those principles for additive manufacturing.

Oblast zaměření: Plasty
Komise : CEN/TC 249 (Plastics)
Původce: ISO\IEC\CEN\CENELEC
K připomínkám do: 24.11.2019
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This International Standard specifies a test method to determine the degree and rate of aerobic biodegradation of plastic materials when settled on marine sandy sediment at the interface between seawater and the seafloor, by measuring the evolved carbon dioxide.

This test method is a simulation under laboratory conditions of the habitat found in different seawater/sediment-areas in the sea, e.g. in a benthic zone where sunlight reaches the ocean floor (photic zone) that, in marine science, is called sublittoral zone

The determination of biodegradation of plastic materials buried in marine sediment is outside the scope of this International Standard.

Measurement of aerobic biodegradation can also be obtained by monitoring the oxygen consumption, as described in ISO 18830.

The conditions described in this International Standard may not always correspond to the optimum conditions for the maximum degree of biodegradation to occur.

Oblast zaměření: Textilie
Komise : CEN/TC 248 (Textiles and textile products)
Původce: CEN
K připomínkám do: 25.11.2019
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This document specifies a test method for determining the presence of organotin compounds. This test method is applicable to all types of materials of textile products.

NOTE       CEN/TR 16741 defines which materials are applicable to this determination.

Komise : CEN/TC 256 (Railway applications)
Původce: CEN
K připomínkám do: 25.11.2019
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This document specifies the measurement method and conditions to obtain reproducible and comparable noise levels on-board all kinds of vehicles operating on rails or other types of fixed track, hereinafter conventionally called “unit”, except for track maintenance vehicles in working modes.

NOTE       For constant speed tests the concept of “comparability” needs further caution, as this term is used as well to classify the measurement precision grade related to track roughness and track decay rates given in this document. Nevertheless, the measurement may be acceptable as type test on a track of controlled acoustic quality, but not compliant to the track specification given in this document.

This document is applicable to type testing. It does not include all the instructions to carry out monitoring testing or evaluation of noise exposure of passengers or drivers over a whole journey.

This document is not applicable to guided buses.

It provides measurement procedures for vehicle interior noise:

—    when the vehicle is moving at constant speed;

—    when the vehicle is stationary;

—    when the vehicle is accelerating or decelerating;

—    in the driver's cab when an external warning horn is sounding.

NOTE       In general, a vehicle type acceptance test would require only a selected subset of these tests to be performed.

It does not provide measurement procedures for:

—    audibility or intelligibility of any audible signals;

—    assessment of warning devices other than warning horns.

The assessment of noise exposure of train crew due to operational conditions is not in the scope of this document.

The results may be used, for example:

—    to characterise the noise inside these units;

—    to compare the internal noise of various units on a particular track section;

—    to collect basic source data for units.

The test procedures specified in this document are of engineering grade (grade 2), that is the preferred one for noise declaration purposes, as defined in EN ISO 12001. If test conditions are relaxed for example as done for monitoring of in-service trains, then the results are no longer of engineering grade.

The procedures specified for accelerating and decelerating tests are of survey grade.

Oblast zaměření: Chlazení
Komise : CEN/TC 44 (Household refrigerating appliances and commercial refrigerated cabinets)
Původce: CEN
K připomínkám do: 26.11.2019
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This document defines classification criteria, test conditions and test procedures for performance testing of packaged refrigerating units for stationary cold room applications. This includes ductless units for cold storage applications at medium temperatures (MT) and low temperatures (LT) in either compact or split designs, fitted with electrically driven compressors, which work according to the vapour compression cycle.

Oblast zaměření: Tlakové nádoby
Komise : CEN/TC 54 (Unfired pressure vessels)
Původce: CEN
K připomínkám do: 26.11.2019
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This document specifies the requirements for safety systems which protect a vessel, a system of vessels, piping, accessories or assemblies from exceeding operating conditions.

It is also applicable to safety related indicators and alarms, signals and warning devices when used in safety systems.

Equipment connected together by piping of adequate capacity, free from potential blockages and which does not contain any valve that can isolate any part from the safety system, can be considered as a single pressure system when considering the requirements for overpressure protection.

Safety systems include the interconnections between the equipment to be protected and any discharge location. This location can either be an outlet to atmosphere or the entry into a closed disposal system.

NOTE          The scope of this document and its relationship to the safety accessories and other protective devices described in the Pressure Equipment Directive are shown in Annex E.

Oblast zaměření: Armatury
Komise : CEN/TC 69 (Industrial valves)
Původce: CEN
K připomínkám do: 26.11.2019
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Amendment

Oblast zaměření: Hračky
Komise : CEN/TC 52 (Safety of toys)
Původce: CEN
K připomínkám do: 26.11.2019
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This document applies to olfactory board games, cosmetic kits, gustative games and supplementary sets. It specifies requirements on the use of substances and mixtures and in some cases on their amount and concentration in olfactory board games, cosmetic kits, gustative games and supplementary sets to such games or kits.

These substances and mixtures are:

—    those classified as hazardous by the EC-legislation applying to hazardous substances [15] and hazardous mixtures [15];

—    substances and mixtures which in excessive amounts could harm the health of the children using them and which are not classified as hazardous by the above-mentioned legislation; and

—    any other chemical substance(s) and mixture(s) delivered with the set.

Furthermore, this document specifies allergenic fragrances which are prohibited in toys, marking requirements, in particular regarding allergenic fragrances, and requirements on a contents list, instructions for use, the equipment intended to be used during the activity and the use of highly flammable liquids.

This document does not apply to cosmetic toys such as play cosmetics for dolls.

NOTE          The terms “substance” and “mixture” are defined in the REACH regulation (EC) No. 1907/2006 [14] and in the CLP regulation (EC) No. 1272/2008 [13].

Oblast zaměření: Potravinářské produkty
Komise : CEN/TC 275 (Food analysis - Horizontal methods)
Původce: CEN
K připomínkám do: 26.11.2019
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This document describes a procedure for the determination of the citrinin content in food (cereals, red yeast rice (RYR)), herbs and food supplements by liquid chromatography tandem mass spectrometry (LC-MS/MS).

This method has been validated for citrinin in red yeast rice and in the formulated food supplements in the range of 2,5 µg/kg to 3000 µg/kg and in wheat flour in the range of 2,5 µg/kg to 100 µg/kg.

Laboratory experiences have shown that this method is also applicable to white rice, herbs such as a powder of ginkgo biloba leaves and the formulated food supplements in the range of 2,5 µg/kg to 50 µg/kg.

Oblast zaměření: Nádobí
Komise : CEN/TC 194 (Utensils in contact with food)
Původce: CEN
K připomínkám do: 30.11.2019
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This document specifies safety and performance requirements for items of ovenware for use in domestic ovens. It is applicable to ovenware regardless of material or method of manufacture.

It is applicable to products intended for use both on top of the stove and in oven.

This document is not applicable to items for single use, throwaway ovenware or ovenware intended for use in a microwave oven only.

Oblast zaměření: Potravinářské produkty
Komise : CEN/TC 302 (Milk and milk products - Methods of sampling and analysis)
Původce: CEN
K připomínkám do: 30.11.2019
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The document specifies the quantitative liquid chromatographic determination of specific sugars (galactose, glucose, fructose, sucrose, lactose, and maltose) in various milk and milk products, applying arabinose as internal standards. The method is applicable for the following different dairy matrices: milk, milk powder, cheese, whey powder, infant formula, milk dessert and yogurt.

Soy containing dairy products are excluded.  The determination of the lactose content in low lactose milk products is excluded.

High performance anion exchange chromatographic method in combination with pulsed amperometric detection (HPAEC-PAD) is applied.

With this method the following thirteen different mono- and disaccharides can be separated: fucose, arabinose, galactose, glucose, fructose, sucrose, lactose, lactulose, maltose, melibiose, trehalose, isomaltulose (e.g. palatinoseTM) and maltotriose.

The method is especially meant for labelling purposes of the six most important sugars which can be present by nature or by addition in milk and milk products. The method is not applicable for sugar contents less than 0,1%.

Komise : CEN/TC 150 (Industrial Trucks. Safety)
Původce: CEN
K připomínkám do: 30.11.2019
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This standard applies to rough-terrain slewing variable-reach trucks (herein-after referred to as ‘trucks’) as defined in ISO 10896-2 that have a specific seated operator’s position, on the left hand side of the boom, or centre position (excluding operator position on the right side of the boom).

This standard specifies a static test method for determining and evaluating the operator’s visibility on a rectangular 1 m boundary close around the slewing rough-terrain variable-reach truck and on a 12 m visibility test circle. Performance requirements for visibility are specified in this standard.

It applies to trucks for operation on work sites.

Komise : CEN/TC 215 (Respiratory and anaesthetic equipment)
Původce: CEN
K připomínkám do: 2.12.2019
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ISO 18190:2016 Clause 1 is replaced by the following

This document specifies essential performance and safety requirements for cuff pressure indicator devices used to indicate the intracuff pressure of airway devices. Such devices are primarily designed to indicate the intracuff pressure of airway devices, such as supralaryngeal airways, tracheal tubes or tracheostomy tubes. This standard is also applicable to devices that combine intracuff pressure indication with a method of cuff inflation (such as a syringe or pump). The device may also provide a method of automatically maintaining cuff inflation at a specific pressure or within a pressure range.

Oblast zaměření: Trubky z plastů
Komise : CEN/TC 155 (Plastics piping systems and ducting systems)
Původce: CEN
K připomínkám do: 2.12.2019
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This document specifies requirements of fitness for purpose of the polyethylene (PE) piping system in the field of the supply of gaseous fuels.

It specifies the definitions of electrofusion, butt fusion and mechanical joints.

It specifies the method of preparation of test piece joints, and the tests to be carried out on these joints for assessing the fitness for purpose of the system under normal and extreme conditions.

It specifies the test parameters for the test methods referred to in this document.

NOTE 1       This document is intended only to be used by the product manufacturer to assess the performance of components according to EN 1555-2, EN 1555-3, and/or EN 1555-4 when joined together under normal and extreme conditions in accordance with this document. It is not intended for on-site testing of pipe systems.

In conjunction with Parts 1 to 4 of EN 1555, it is applicable to PE pipes, fittings, valves, their joints and to joints with components of other materials intended to be used under the following conditions:

a)     a maximum operating pressure, MOP, up to and including 10 bar [1];

b)    an operating temperature of 20 °C as reference temperature.

NOTE 2       For other operating temperatures, derating coefficients can be used, see Annex A.

EN 1555 (all parts) covers a range of maximum operating pressures and gives requirements concerning colours and additives.

NOTE 3       It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes.

 

[1]             1 bar = 0,1 MPa.

Oblast zaměření: Trubky z plastů
Komise : CEN/TC 155 (Plastics piping systems and ducting systems)
Původce: CEN
K připomínkám do: 2.12.2019
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This document specifies the characteristics of valves made from polyethylene (PE) for piping systems in the field of the supply of gaseous fuels.

It is applicable to unidirectional and bi-directional valves with spigot end or electrofusion socket intended to be fused with PE pipes or fittings conforming to EN 1555-2 and EN 1555-3 respectively.

The PE spigot or electrofusion ends for valves made of material other than polyethylene is intended to be in accordance with EN 1555-3.

It also specifies the test parameters for the test methods referred to in this document.

In conjunction with Parts 1, 2, 3 and 5 of EN 1555, it is applicable to PE valves, their joints and to joints with components of PE and other materials intended to be used under the following conditions:

a)     a maximum operating pressure, MOP, up to and including 10 bar [1] 2;

For the purpose of this document and the references to EN 28233, MOP is considered to be nominal pressure.

b)    an operating temperature of 20 °C as reference temperature;

NOTE 1       For other operating temperatures, derating coefficients can be used, see EN 1555-5.

c)     an operating temperature between −20 °C and +40 °C.

EN 1555 (all parts) covers a range of maximum operating pressures and gives requirements concerning colours and additives.

NOTE 2       It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes.

This document covers valve bodies designed for connection with pipes with a nominal outside diameter dn ≤ 400 mm.

 

[1]              1 bar = 0,1 MPa.

Oblast zaměření: Trubky z plastů
Komise : CEN/TC 155 (Plastics piping systems and ducting systems)
Původce: CEN
K připomínkám do: 2.12.2019
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This document specifies the characteristics of fusion fittings made from polyethylene (PE) as well as of mechanical fittings for piping systems in the field of the supply of gaseous fuels.

It also specifies the test parameters for the test methods referred to in this document.

In conjunction with Parts 1, 2, 4 and 5 of EN 1555, it is applicable to PE fittings, their joints and to joints with components of PE and other materials intended to be used under the following conditions:

a)    a maximum operating pressure, MOP, up to and including 10 bar [1];

NOTE 1       For the purpose of this document and referring to ISO 17885, MOP can be considered to be nominal pressure.

b)    an operating temperature of 20 °C as reference temperature.

NOTE 2       For other operating temperatures, derating coefficients can be used; see EN 1555-5.

EN 1555 (all parts) covers a range of maximum operating pressures and gives requirements concerning colours and additives.

NOTE 3       It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes.

This document is applicable for fittings of the following types:

c)    electrofusion fittings;

d)   spigot end fittings (for butt fusion using heated tools and electrofusion socket fusion);

e)    mechanical compression fittings.

NOTE 4       The fittings can be, for example, in the form of couplers, equal and reduced tees, reducers, bends or caps.

 

[1]             1 bar = 0,1 MPa.

Oblast zaměření: Trubky z plastů
Komise : CEN/TC 155 (Plastics piping systems and ducting systems)
Původce: CEN
K připomínkám do: 2.12.2019
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This document specifies the general aspects of polyethylene (PE) piping systems in the field of the supply of gaseous fuels.

It also specifies the test parameters for the test methods referred to in this document.

In conjunction with Parts 2 to 5 of EN 1555, this document is applicable to PE pipes, fittings, and valves, their joints and to joints with components of other materials intended to be used under the following conditions:

a)     a maximum operating pressure, MOP, up to and including 10 bar [1];

b)    an operating temperature of 20 °C as reference temperature.

NOTE 1       For other operating temperatures, derating coefficients can be used, see prEN 1555-5:2019 [1].

EN 1555 (all parts) covers a. range of maximum operating pressures and gives requirements concerning colours.

NOTE 2       It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes.

 

[1]              1 bar = 0,1 MPa.

Oblast zaměření: Trubky z plastů
Komise : CEN/TC 155 (Plastics piping systems and ducting systems)
Původce: CEN
K připomínkám do: 2.12.2019
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This document specifies the characteristics of pipes made from polyethylene (PE) for piping systems in the field of the supply of gaseous fuels.

It also specifies the test parameters for the test methods referred to in this document.

In conjunction with Parts 1 and 3 to 5 of EN 1555, it is applicable to PE pipes, their joints and to joints with components of PE and other materials intended to be used under the following conditions:

a)     a maximum operating pressure, MOP, up to and including 10 bar 1;

b)    an operating temperature of 20 °C as reference temperature.

NOTE 1       For other operating temperatures, derating coefficients can be used, see prEN 1555-5:2019.

EN 1555 covers a range of maximum operating pressures and gives requirements concerning colours and additives.

It covers three types of pipe:

—    PE pipes (outside diameter dn) including any identification stripes;

—    PE pipes with co-extruded layers on either or both the outside and/or inside of the pipe (total outside diameter dn) as specified in Annex A, where all layers have the same MRS rating;

A coextruded pipe made of a combination of PE 100 and PE 100-RC layers shall be regarded as PE 100 and marked accordingly.

—    PE pipes (outside diameter dn) with a peelable, contiguous thermoplastics additional layer on the outside of the pipe (‘coated pipe’) as specified in Annex B.

NOTE 2       It is the responsibility of the purchaser or specifier to make the appropriate selections from these aspects, taking into account their particular requirements and any relevant national regulations and installation practices or codes.

 

1             1 bar = 0,1 MPa.