Ämnesområden

Ämnesområden: Plast: allmänt
Kommittébeteckning: SIS/TK 156 (Plast)
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1.1 This document specifies a method for determining the Izod impact strength of plastics under defined conditions. A number of different types of specimen and test configurations are defined. Different test parameters are specified according to the type of material, the type of test specimen and the type of notch.

1.2 The method is used to investigate the behaviour of specified types of specimen under the impact conditions defined and for estimating the brittleness or toughness of specimens within the limitations inherent in the test conditions.

1.3 The method is suitable for use with the following range of materials:

— rigid thermoplastic moulding and extrusion materials, including filled and reinforced compounds in addition to unfilled types; rigid thermoplastics sheets;

— rigid thermosetting moulding materials, including filled and reinforced compounds; rigid thermosetting sheets, including laminates;

— fibre-reinforced thermosetting and thermoplastic composites incorporating unidirectional or non-unidirectional reinforcements such as mat, woven fabrics, woven rovings, chopped strands, combination and hybrid reinforcements, rovings and milled fibres and sheet made from pre-impregnated materials (prepregs);

— thermotropic liquid-crystal polymers.

1.4 The method is not normally suitable for use with rigid cellular materials and sandwich structures containing cellular material. Notched specimens are also not normally used for long-fibre-reinforced composites or thermotropic liquid-crystal polymers.

1.5 The method is suited to the use of specimens which can be either moulded to the chosen dimensions, machined from the central portion of a standard multipurpose test specimen (see ISO 20753) or machined from finished or semi-finished products such as mouldings, laminates and extruded or cast sheet.

1.6 The method specifies preferred dimensions for the test specimen. Tests which are carried out on specimens of different dimensions or with different notches, or specimens which are prepared under different conditions, may produce results which are not comparable. Other factors, such as the energy capacity of the apparatus, its impact velocity and the conditioning of the specimens can also influence the results. Consequently, when comparative data are required, these factors are to be carefully controlled and recorded.

1.7 The method is not intended to be used as a source of data for design calculations. Information on the typical behaviour of a material can be obtained, however, by testing at different temperatures, by varying the notch radius and/or the thickness and by testing specimens prepared under different conditions.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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This International Standard applies to masks and their accessories used to connect sleep apnoea

breathing therapy equipment to the patient. It specifies requirements for masks and accessories,

including any connecting element, that are required to connect the patient-connection port of sleep

apnoea breathing therapy equipment to a patient for the application of sleep apnoea breathing

therapy (e.g. nasal masks, exhaust ports and headgear).

Sleep apnoea breathing therapy equipment is covered by ISO 80601-2-70. Figure A.1 shows the

typical elements of this International Standard together with the sleep apnoea breathing therapy

equipment of ISO 80601-2-70 that form a sleep apnoea breathing system.

This International Standard does not cover oral appliances.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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This document specifies:

— the general principles governing the biological evaluation within a risk management process of the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments;

— the general categorization of gas pathways based on the nature and duration of their contact with the gas stream;

— the evaluation of existing relevant data from all sources;

— the identification of gaps in the available data set on the basis of a risk analysis;

— the identification of additional data sets necessary to analyse the biological safety of the gas pathway;

— the assessment of the biological safety of the gas pathway.

This document covers general principles regarding biocompatibility assessment of medical device materials, which make up the gas pathway, but does not cover biological hazards arising from any mechanical failure, unless the failure introduces a toxicity risk (e.g. by generating particulates). The other parts of ISO 18562 cover specific tests that address potentially hazardous substances that are added to the respirable gas stream and establish acceptance criteria for these substances.

This document addresses potential contamination of the gas stream arising from the gas pathways within the medical device, which might then be conducted to the patient.

This document applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.

This document does not address biological evaluation of the surfaces of medical devices that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.

Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving equipment, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing system filters and Y-pieces as well as any breathing accessories intended to be used with such medical devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.

This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.

EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).

Future parts might be added to address other relevant aspects of biological testing including additional contamination that might arise from the gas pathway because of the presence of drugs and anaesthetic agents added to the gas stream.

NOTE 1 Some authorities having jurisdiction require evaluation of these risks as part of a biological evaluation.

NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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This document specifies tests for the emissions of particulate matter from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify particles from 0,2 μm diameter to 10 μm diameter that are emitted by the medical device, its parts or accessories into the respirable gas stream. This document establishes acceptance criteria for these tests. This document does not address nanoparticles. Insufficient data exist to establish exposure limits for particles less than 0,2 μm in diameter.

NOTE 1 Smaller and larger particles could also present biological hazards, and additional information outside the scope of this document can be needed to meet requirements of some authorities having jurisdiction.

This document therefore adopts the same approach as the US Environmental Protection Agency (EPA) in setting limits based solely on particle size and not their chemistry.

This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.

This document applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.

This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.

Medical devices, parts or accessories, containing gas pathways that are addressed by this document, include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces, and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.

This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.

EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 (all parts).

NOTE 2 This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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This document specifies tests for the emissions of volatile organic compounds (vocs) from the gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify emissions of vocs that are added to the respirable gas stream by the materials of the gas pathway. This document establishes acceptance criteria for these tests.

This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.

This document applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing.

This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series[1].

Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.

This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.

EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder or room air taken into the medical device is not addressed by ISO 18562 series.

This document is intended to be read in conjunction with ISO 18562-1.

NOTE This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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This document specifies tests for substances leached by liquid water condensing into gas pathways of a medical device, its parts or accessories, which are intended to provide respiratory care or supply substances via the respiratory tract to a patient in all environments. The tests of this document are intended to quantify hazardous water-soluble substances that are leached from the medical device, its parts or accessories by condensate and then conveyed by that liquid to the patient. This document establishes acceptance criteria for these tests.

This document addresses potential contamination of the gas stream arising from the gas pathways, which is then conducted to the patient.

This document applies over the expected service life of the medical device in normal use and takes into account the effects of any intended processing or reprocessing

This document does not address biological evaluation of the surfaces of gas pathways that are in direct contact with the patient. The requirements for direct contact surfaces are found in the ISO 10993 series.

Medical devices, parts or accessories containing gas pathways that are addressed by this document include, but are not limited to, ventilators, anaesthesia workstations (including gas mixers), breathing systems, oxygen conserving devices, oxygen concentrators, nebulizers, low-pressure hose assemblies, humidifiers, heat and moisture exchangers, respiratory gas monitors, respiration monitors, masks, mouth pieces, resuscitators, breathing tubes, breathing systems filters, Y-pieces and any breathing accessories intended to be used with such devices. The enclosed chamber of an incubator, including the mattress, and the inner surface of an oxygen hood are considered to be gas pathways and are also addressed by this document.

This document does not address contamination already present in the gas supplied from the gas sources while medical devices are in normal use.

EXAMPLE Contamination arriving at the medical device from gas sources such as medical gas pipeline systems (including the non-return valves in the pipeline outlets), outlets of pressure regulators connected or integral to a medical gas cylinder, or room air taken into the medical device is not addressed by ISO 18562 series.

This document does not address contact with drugs or anaesthetic agents. If a medical device is intended to be used with anaesthetic agents or drugs, then additional testing can be required.

This document is intended to be read in conjunction with ISO 18562-1.

NOTE This document has been prepared to address the relevant essential principles of safety and performance as indicated in Annex B.

Kommittébeteckning: SIS/TK 329 (Anestesi- och respiratorutrustning)
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This document applies to the BASIC SAFETY and ESSENTIAL PERFORMANCE of a HUMIDIFIER, also

hereafter referred to as ME EQUIPMENT, in combination with its ACCESSORIES, the combination also

hereafter referred to as ME SYSTEM.

This document is also applicable to those ACCESSORIES intended by their MANUFACTURER to be

connected to a HUMIDIFIER where the characteristics of those ACCESSORIES can affect the BASIC

SAFETY or ESSENTIAL PERFORMANCE of the HUMIDIFIER.

EXAMPLE 1 Heated BREATHING TUBES (heated‐wire BREATHING TUBES) or ME EQUIPMENT intended to

control these heated BREATHING TUBES (heated BREATHING TUBE controllers).

NOTE 1 Heated BREATHING TUBES and their controllers are ME EQUIPMENT and are subject to the

requirements of IEC 60601‐1.

NOTE 2 ISO 5367 specifies other safety and performance requirements for BREATHING TUBES.

This document includes requirements for the different medical uses of humidification, such as

invasive ventilation, non‐invasive ventilation, nasal high‐flow therapy, and obstructive sleep

apnoea therapy, as well as humidification therapy for tracheostomy PATIENTS.

NOTE 3 A HUMIDIFIER can be integrated into other equipment. When this is the case, the requirements of

the other equipment also apply to the HUMIDIFIER.

EXAMPLE 2 Heated HUMIDIFIER incorporated into a critical care ventilator where ISO 80601‐2‐12[12]

also applies.

EXAMPLE 3 Heated HUMIDIFIER incorporated into a homecare ventilator for dependent PATIENTS where

ISO 80601‐2‐72[14] also applies.

EXAMPLE 4 Heated HUMIDIFIER incorporated into sleep apnoea therapy equipment where ISO 80601‐2‐

70[13] also applies.

This document also includes requirements for an ACTIVE HME (HEAT AND MOISTURE EXCHANGER),

ME EQUIPMENT which actively adds heat and moisture to increase the humidity level of the gas

delivered from the HME to the PATIENT. This document is not applicable to a passive HME, which

returns a portion of the expired moisture and heat of the PATIENT to the respiratory tract during

inspiration without adding heat or moisture.

NOTE 4 ISO 9360‐1[5] and ISO 9360‐2[6] specify the safety and performance requirements for a passive

HME.

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

IEC 60601‐1:2005+AMD1:2012, 7.2.13 and 8.4.1.

NOTE 5 Additional information can be found in IEC 60601‐1:2005+AMD1:2012, 4.2.

This document does not specify the requirements for cold pass‐over or cold bubble‐through

humidification devices, the requirements for which are given in ISO 20789:—[8]

This document is not applicable to equipment commonly referred to as “room humidifiers” or

humidifiers used in heating, ventilation and air conditioning systems, or HUMIDIFIERS

incorporated into infant incubators.

This document is not applicable to nebulizers used for the delivery of drugs to PATIENTS.

NOTE 6 ISO 27427[10] specifies the safety and performance requirements for nebulizers.

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

Kommittébeteckning: SIS/TK 302 (Multimedia, kodning och representation)
Källa: ISO
Svarsdatum: den 1 okt 2019
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This part of the MPEG-7 standard describes the assessment of conformance to ISO/IEC 15938-15 Compact descriptors for video analysis, as well as the reference software.

Section 5 describes conformance testing of CDVA descriptors and Section 6 provides the reference software for extraction and matching of CDVA descriptors.

Ämnesområden: Sanitet
Kommittébeteckning: SIS/TK 198 (Vatten- och avloppssystem)
Källa: CEN
Svarsdatum: den 1 okt 2019
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This document provides the Product Category Rule (PCR) for Ceramic Sanitary Appliances in accordance with EN 15804:2012+ A1:2013 (this document will be named below as EN 15804).

The document applies for Ceramic Sanitary Appliances made out of Vitreous China (VC) and Fine Fire Clay (FFC). Ceramic Sanitary Appliances are e.g. WC pans and WC suites in accordance with EN 997, urinals in accordance with EN 13407, wash basins in accordance with EN 14688, communal washing troughs in accordance with EN 14296 and bidets in accordance with EN 14528.

NOTE This document can be applicable to other ceramic sanitary appliances.

Kommittébeteckning: SIS/TK 183 (Geoteknik och geokonstruktioner)
Källa: CEN
Svarsdatum: den 3 okt 2019
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This standard deals with the equipment requirements, execution and reporting of field vane tests for the measurement of peak and remoulded vane shear strength together with the sensitivity of fine-grained soils. In addition, post-peak shear strength behaviour can be evaluated. Two types of field vane test are described; the ordinary field vane test (FVT) and the fast field vane test (FVT-F).

The uncertainties of the vane test result are described in Annex C.

NOTE 1 This part of ISO 22476 fulfils the requirements for field vane tests as part of the geotechnical investigation and testing according to EN 1997-1 and EN 1997-2

NOTE 2 This part of ISO 22476 covers onshore and nearshore field vane testing

Kommittébeteckning: SIS/TK 248 (Vägutrustning)
Källa: CEN
Svarsdatum: den 3 okt 2019
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This document lists KSPIs providing information that is relevant for assessing the sustainability of Noise Reducing Devices (NRD) products when used as complete systems alongside roads.

The KSPIs identified in this document are intended for the assessment of the technical, environmental, economic and social performance of NRDs over their life cycle and include the considerations listed in Annex A.

This document does not address the assessment of sustainability but provides the relevant information for such assessment.

Ämnesområden: Möbler
Kommittébeteckning: SIS/TK 391 (Möbler)
Källa: ISO
Svarsdatum: den 4 okt 2019
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This document specifies methods for the determination of the dimensions of office chairs.

This document does not contain dimensional specifications or requirements.

Kommittébeteckning: SIS/TK 608 (Transportörer och Staplingskranar)
Källa: CEN
Svarsdatum: den 4 okt 2019
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This document applies to all types of Storage and Retrieval (S/R) machines, restricted to the rails on which they travel within and outside the aisles for the storage and retrieval of unit loads and/or long goods such as bar materials and/or for order picking or similar duties. These machines shall embody lifting means along a mast and may include lateral handling facilities. Also included is the transfer equipment used to change between aisles. Control of machines may range from manual to fully automatic.

S/R-machine-related satellite vehicles according to definition 3.20 are included as a load-handling-device (LHD).

References in this standard to racking, buildings and systems only apply where it is necessary to assess the hazards and risks at their interfaces with S/R machines.

This document deals with all significant hazards relevant to rail dependent storage and retrieval equipment, when they are used under the conditions intended by the manufacturer including reasonably foreseeable misuse (see Annex F "List of significant hazards")).

This document applies to machines and equipment that are manufactured after the date of issue of this document.

Illustrations of examples of machines and transfer equipment to which this standard applies are shown in Annex A.

Safety requirements and/or measures in this standard apply to equipment used under indoor conditions. However, additional risk assessments and safety measures need to be considered for uses in severe conditions, e.g. extremely high temperatures, loads, the nature of which could lead to a dangerous situation (e.g. especially brittle loads, explosives), earthquake effects and also contact with foodstuff.

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

Kommittébeteckning: SIS/TK 110 (Akustik och buller)
Källa: ISO
Svarsdatum: den 5 okt 2019
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This document specifies the conditions for obtaining reproducible and comparable measurement results of the airborne sound emitted by vessels of all kinds on inland waterways and in ports and harbours, except powered recreational craft as specified in the ISO 14509 series.[2] This document is applicable to sea-going vessels, harbour vessels, dredgers, and all watercraft including non-displacement craft, used or capable of being used as a means of transport on water. There are no limitations to the application of this document with regard to speed and length of vessels.

All noise data obtained in accordance with this document are referred to a reference distance of 25 m.

Ämnesområden: Anordningar för sport
Kommittébeteckning: SIS/TK 184 (Golvbeläggningar)
Källa: CEN
Svarsdatum: den 6 okt 2019
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This document describes the minimum procedures for the sampling of performance infills used within synthetic turf surfaces to verify compliance with toxicology, environmental and performance regulations and standards.

Four sampling procedures are specified:

Method 1 is intended based on taking samples during production of the infill material.

Method 2 describes how to take samples from big bags.

Method 3 describes how to take samples from small bags.

Method 4 describes a procedure for taking samples from a synthetic turf (e.g. sports, recreational or landscaping surface).

The procedures described are suitable for all forms of infill.

Kommittébeteckning: SIS/TK 189 (Innemiljö och energianvändning i byggnader)
Källa: CEN
Svarsdatum: den 6 okt 2019
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This International Standard establishes a vocabulary of terms used in the field of thermal insulation covering

materials, products, components and applications. Some of the terms may have a different meaning when used

in other industries or applications.

NOTE - In addition to terms used in English and French, two of the three official ISO languages (English, French and

Russian), this document gives the equivalent terms in German; these are published under the responsibility of the member

body for Germany (DIN), and are given for information only. Only the terms and definitions given in the official languages

can be considered as ISO terms and definitions.

Kommittébeteckning: SIS/TK 189 (Innemiljö och energianvändning i byggnader)
Källa: CEN
Svarsdatum: den 8 okt 2019
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This document provides a transparent framework for reporting on the choices related to the procedure to determine PEFs and CO2 Emission coefficients for energy delivered to and/or exported by the buildings as described in EN ISO 52000-1:2017. Exported PEFs and CO2 Emission coefficients can be different from those chosen for delivered energy.

This document can be considered as a supporting/complementing standard to EN ISO 52000-1, as the latter requires values for the PEFs and GHG Emissions factors to complete the EPB calculation.

Table 1 shows the relative position of this document within the set of EPB standards in the context of the modular structure as set out in EN ISO 52000-1.

Ämnesområden: Vägbyggnad. Utförande
Kommittébeteckning: SIS/TK 225 (Anläggningsmaskiner)
Källa: ISO
Svarsdatum: den 8 okt 2019
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This International Standard establishes the terminology for bituminous binder sprayers and binder sprayers chipping spreaders. It provides the terminology for the machine and its components, also the definitions of operation principles and parameters.

This document covers cold and hot binder sprayers.

NOTE additional requirements can apply in some regions for the transportation of bituminous binders.

This International Standard also establishes the parameters required for the technical characteristics of the whole machine and its components, such as the transport vehicle bituminous binder spraying device and chipping spreading device, for commercial specifications.