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This European Standard specifies the conventions and mathematical procedures to be adopted in calculating the photometric performance of road lighting installations designed in accordance with the parameters described in EN 13201-2 to ensure that every lighting calculation is based on the same mathematical principles.
The design procedure of a lighting installation also requires the knowledge of the parameters involved in the described model, their tolerances and variability. These aspects are not considered in this part of EN 13201 but a procedure to analyse their contribution in the expected results is suggested in EN 13201-4 and it can also be used in the design phase.
This document defines cyber security requirements for products with digital elements belonging to product category “Hardware Device with Security Boxes” (hereinafter called “Product” or “HWSB product”).
The technical description of “Hardware Devices with Security Boxes” can be found in Annex II of [CRA].
The Hardware Devices with Security Boxes in scope are designed for deployment in a range of environments and where the threat landscape includes attackers with various attack potential.
HWSB are hardware-based systems intended to provide secure storage, processing and use of sensitive data, including cryptographic assets, within a protected hardware boundary (envelope).
This document applies to the HWSB part of the product. The applicability of this document to specific products is determined based on their intended purpose, use case and risk assessment.
This document specifies the dimensions, the method of sampling, the preparation of the test specimens and the conditions for performing the tensile test in order to determine the short-term tensile welding factor.
A tensile test can be used in conjunction with other tests (e.g. bend, tensile creep, macro) to assess the performance of welded assemblies, made from thermoplastics materials.
The test is applicable to welded semi-finished products made from thermoplastics materials filled or unfilled, but not reinforced, irrespective of the welding process used.
This document specifies guidelines and recommendations to be followed prior to carrying out
dimensional measurements on three-dimensional (3D) volumetric X-ray Computed Tomographic (XCT)
images of additive manufacturing (AM) series production parts. It is applicable to cone beam XCT
systems. However, these guidelines and recommendations can easily be transposed to fan beam XCT
systems.
The process to be followed prior to performing dimensional measurement on 3D volumetric XCT
images of AM series production parts, in this standard, is divided into two steps:
Step 1: Quantification of an XCT system performance, in terms of image quality and basic
dimensional measurement accuracy, with a reference object and eventually a Representative Quality
Indicators (RQI), with the specific part (part chosen from the AM series production parts) XCT setting
under certain environmental conditions. This step leads to the determination of the image quality, the
voxel size and the basic dimensional measurement accuracy of an XCT system;
Step 2: Validation of the XCT system compliance, in terms of dimensional measurement accuracy,
with the specific part, with the chosen XCT setting under the specific environmental conditions. This
step leads to a simplified determination of the dimensional measurement uncertainty of each
measurand of the specific part.
If step 1 does not comply with the set requirements, the XCT system cannot be used for step 2.
This document does not claim to provide a definitive method to determine XCT dimensional
measurement accuracy, which, given the complexity of an XCT process, is not yet established. For the
same reason, it is addressed to qualified XCT operators with the support of metrology experts.
This document is dedicated to AM series production parts and its aim is to provide a methodology for
controlling the geometric specificities associated with AM (internal shapes, lattice structures). It is
applicable on parts that are fabricated by any type of AM categories of processes and material
provided the X-ray penetration lengths are sufficient to scan the test part.
These prior quantification and validation processes, which allow dimensional measurements to be carry
out on 3D volumetric XCT images of AM series production parts, are valid for a specific part geometry
in a given material associated with a chosen XCT setting (magnification ; & XCT acquisition and
reconstruction parameters of the specific part) under specific environmental conditions for the
measurands specified. The quantification and validation processes are reconsidered when different
geometry of the part or material or XCT setting or environmental conditions or measurands are taken
into account.
This document identifies common failure modes, which can occur within operations across additive manufacturing (AM) process categories defined in ISO/ASTM 52900. It lists state-of-the-art failure modes, which can lead to risks within AM parts and equipment, as well as providing informative examples of corresponding failure effects and mitigation actions.
This document can be used to aid manufacturers in their risk management. While doing so it supports the implementation of AM as a production method within critical applications and regulated industries. This document helps to address the requirements for risk management set by regulated industries for part and production method compliance.
Technology specific failure modes will be addressed in separate standards, including but not limited to PBF-LB/M, PBF-LB/P, MEX, MJT, BJT, and DED.
This document aims to close the existing gap between general risk management standards, such as ISO 31000 or ISO 14971 (medical), and the know-how gap of existing failure modes of the AM process category and their integrated workflow.
The standard maps risks according to AM processes defined within ISO/ASTM 52920.
This document does not cover environment, health and safety risks and will not measure, assess, or evaluate the risk impact on the AM part to be produced. It does not list the part specific input and output parameters, during the respective process steps. This task is dedicated to the risk management evaluation teams, which usually comprise quality managers and product domain specific experts.
The document enables all part owners and manufacturers to use it for the risk mapping activities, to support subsequent risk assessments, continuous improvement, validation planning, estimation of manufacturing efforts, and conformity audits.
For risk examples that are relevant only to specific AM machinery brands, manufacturers might consider use of the informative annex.
This document defines the rules to be applied for symbolic representation of welded joints on technical drawings. This can include information about the geometry, manufacture, quality and testing of the welds. The principles of this document can also be applied to soldered and brazed joints.
It is recognized that there are two different approaches in the global market to designate the arrow side and other side on drawings. In this document:
— clauses, tables and figures which carry the suffix letter "A" are applicable only to the symbolic representation system based on a dual reference line;
— clauses, tables and figures which carry the suffix letter "B" are applicable only to the symbolic representation system based on a single reference line;
— clauses, tables and figures which do not have the suffix letter "A" or "B" are applicable to both systems.
The symbols shown in this document can be combined with other symbols used on technical drawings, for example to show surface finish requirements.
An alternative designation method is presented which can be used to represent welded joints on drawings by specifying essential design information such as weld dimensions, quality level, etc. The joint preparation and welding process(es) are then determined by the production unit in order to meet the specified requirements.
NOTE Examples given in this document, including dimensions, are illustrative only and are intended to demonstrate the proper application of principles.
ISO 1924-2:2008 specifies a method for measuring the tensile strength, strain at break and tensile energy absorption of paper and board, using a testing machine operating at a constant rate of elongation (20 mm/min). ISO 1924-2:2008 also specifies equations for calculating the tensile index, the tensile energy absorption index and the modulus of elasticity.
Testing in conformance with ISO 1924-2:2008 always includes the measurement of tensile strength. Measurement or calculation of other properties is subject to agreement between the parties concerned.
ISO 1924-2:2008 is applicable to all papers and boards, including papers with a high strain at break if the results are within the capacity of the testing machine. It also applies to the components of corrugated board but not, however, to corrugated board itself.
ISO 7198:2016 specifies requirements for the evaluation of vascular prostheses and requirements with respect to nomenclature, design attributes and information supplied by the manufacturer, based upon current medical knowledge. Guidance for the development of in vitro test methods is included in an informative annex to ISO 7198:2016. It can be considered as a supplement to ISO 14630:2012, which specifies general requirements for the performance of non-active surgical implants.
NOTE Due to the variations in the design of implants covered by ISO 7198 :2016 and, in some cases, due to the relatively recent development of some of these implants (e.g. bioabsorbable vascular prostheses, cell based tissue engineered vascular prostheses), acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, appropriate revision of ISO 7198 :2016 will be necessary.
It is applicable to sterile tubular vascular grafts implanted by direct visualization surgical techniques as opposed to fluoroscopic or other non-direct imaging (e.g. computerized tomography or magnetic resonance imaging), intended to replace, bypass, or form shunts between segments of the vascular system in humans and vascular patches intended for repair and reconstruction of the vascular system.
Vascular prostheses that are made of synthetic textile materials and synthetic non-textile materials are within the scope of ISO 7198:2016.
While vascular prostheses that are made wholly or partly of materials of non-viable biological origin, including tissue engineered vascular prostheses are within the scope, ISO 7198:2016 does not address sourcing, harvesting, manufacturing and all testing requirements for biological materials. It is further noted that different regulatory requirements might exist for tissues from human and animal sources.
Compound, coated, composite, and externally reinforced vascular prostheses are within the scope of ISO 7198:2016.
Endovascular prostheses implanted using catheter delivery and non-direct visualization are excluded from the scope of ISO 7198:2016. It includes information on the development of appropriate test methods for graft materials, referenced in ISO 25539‑1 for materials used in the construction of endovascular prostheses (i.e. stent-grafts).
NOTE Requirements for endovascular prostheses are specified in ISO 25539‑1.
The valve component of valved conduits constructed with a tubular vascular graft component, and the combination of the valved component and the tubular vascular graft component, are excluded from the scope of ISO 7198:2016. It can be helpful in identifying the appropriate evaluation of the tubular vascular graft component of a valved conduit but specific requirements and testing are not described for these devices.
Cardiac and pericardial patches, vascular stents, accessory devices such as anastomotic devices, staplers, tunnelers and sutures, and pledgets are excluded from the scope of ISO 7198:2016.
NOTE Requirements for vascular stents are specified in ISO 25539‑2.
Requirements regarding cell seeding are excluded from the scope of ISO 7198:2016. Tissue engineered vascular prostheses that contain or are manufactured using cells present many distinct manufacturing (e.g. aseptic processing, cell seeding, etc.) and testing issues than those produced with synthetic or non-viable biological materials. The in vitro testing requirements that are outlined in ISO 7198:201
This document provides terminology, concepts, requirements, and guidance for logging of AI systems.
It is primarily intended for organizations placing on the market or putting into service AI systems and is not specific to any particular sector.
This document specifies the technical conditions for inspection and delivery of wrought aluminium and wrought aluminium alloy sheet, strip and plate for general applications. It also includes provisions for ordering and testing.
It applies to products with a thickness over 0,20 mm up to and including 400 mm.
For many special applications of aluminium strip, sheet and plate, specific European Standards exist, where different or additional requirements are formulated and the appropriate alloys and tempers are selected: see Annex A. Most of these special European Standards refer to provisions of this document.
The selection of the relevant special European Standards is under the responsibility of the purchaser.
Specific European Standards are available for applications involving special properties, such as corrosion resistance, toughness, fatigue strength, surface appearance or welding properties.
This document specifies two test methods for the determination of the resistance of the edges of brittle ceramic materials to be damaged by chipping.
This document is applicable to homogeneous monolithic ceramics with flat surfaces and straight sharp or chamfered edges.
This document specifies minimum requirements for the design and performance of stretchers and other patient handling equipment used in road ambulances for the handling and carrying of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
This document specifies minimum requirements for the design and performance of heavy duty stretchers used in road ambulances for the treatment and transportation of patients. It aims to ensure patient safety and minimize the physical effort required by staff operating the equipment.
This document specifies minimum requirements for the design and performance of foldable patient transfer chairs, which are used for the conveyance of patients to and/or from road ambulances. It aims to ensure patient safety and to minimize the physical effort required by staff operating the equipment.