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prEN ISO 180 - Plastics - Determination of Izod impact strength (ISO/DIS 180:2019)
Svarsdatum: den 1 okt 2019
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:
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.
prEN ISO 17510 - Medical devices - Sleep apnoea breathing therapy - Masks and application accessories (ISO 17510:2015)
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.
prEN ISO 18562-1 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process (ISO 18562-1:2017)
— 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 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.
prEN ISO 18562-2 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter (ISO 18562-2:2017)
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.
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 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.
prEN ISO 18562-3 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds (VOCs) (ISO 18562-3:2017)
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].
This document is intended to be read in conjunction with ISO 18562-1.
prEN ISO 18562-4 - Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate (ISO 18562-4:2017)
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 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 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.
prEN ISO 80601-2-74 - Medical electrical equipment - Part 2-74: Particular requirements for basic safety and essential performance of respiratory humidifying equipment (ISO 80601-2-74:2017)
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.
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]
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
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.
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.
ISO/IEC DIS 15938-16 - Information technology - Multimedia content description interface - Part 16: Conformance and reference software for compact descriptors for video analysis
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.
prEN 16578 - Product Category Rules for ceramic sanitary appliances
Ämnesområden: Sanitet
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.
prEN ISO 22476-9 - Ground investigation and testing - Field testing - Part 9: Field vane test
Ämnesområden: Markarbete. Utgrävning. Grundläggning. Arbete under jord
Svarsdatum: den 3 okt 2019
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).
NOTE 2 This part of ISO 22476 covers onshore and nearshore field vane testing
prEN 17383 - Road traffic noise reducing devices - Sustainability : Key Sustainability Performance Indicators (KSPI) Declaration
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.
ISO/DIS 24496 - Office furniture - Office chairs - Methods for the determination of dimensions
Ämnesområden: Möbler
Kommittébeteckning: SIS/TK 391 (Möbler)
This document specifies methods for the determination of the dimensions of office chairs.
This document does not contain dimensional specifications or requirements.
ISO/DIS 2922 - Acoustics - Measurement of airborne sound emitted by vessels on inland waterways and harbours
Ämnesområden: Buller förorsakat av transportmedel
Svarsdatum: den 5 okt 2019
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.
prEN 17409 - Surfaces for sports areas - Code of practice for the sampling of performance infills used within synthetic turf surfaces
prEN 17423 - Energy performance of buildings - Determination and reporting of Primary Energy Factors (PEF) and CO2 emission coefficient - General Principles, Module M1-7
Ämnesområden: Luftkvalitet: allmänt; Värmeisolering
Svarsdatum: den 8 okt 2019
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.
prEN ISO 80601-2-67 - Medical Electrical Equipment - Part 2-67:Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO/DIS 80601-2-67:2019)
prEN ISO 80601-2-69 - Medical electrical equipment - Part 2-69: Particular requirements for basic safety and essential performance of oxygen concentrator equipment (ISO/DIS 80601-2-69)
ISO/DIS 15643 - Road construction and maintenance equipment - Bituminous binder sprayers and binder sprayers/chipping spreaders - Terminology and commercial specifications
Ämnesområden: Vägbyggnad. Utförande
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.