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1.1 Scope of EN 1993-1-10 (1) EN 1993-1-10 specifies rules for the selection of steel grades and qualities related to fracture toughness to avoid brittle fracture. NOTE Steel quality is also known as (Charpy) subgrade. (2) EN 1993-1-10 specifies rules to specify through thickness properties for welded elements to reduce the risk of lamellar tearing. (3) EN 1993-1-10 specifies additional toughness requirements for specific cases to ensure upper shelf toughness in relation to design ultimate resistance in tension and seismic design. (4) EN 1993-1-10 specifies rules for structural steels as listed in EN 1993-1-1. This document applies to steel grades S235 to S700. (5) EN 1993-1-10 specifies rules that apply to the selection of parent material only. (6) EN 1993-1-10 specifies rules that apply to steel materials covered by EN 1993-1-1:2022, 5.1(3), provided that each individual piece of steel is tested in accordance with the requirements of EN 1993 1 1:2022, 5.2.1 and EN 1090-2:2018+A1:2024, 5.1. (7) This document does not apply to material salvaged from existing steelwork subjected to fatigue or fire. 1.2 Assumptions (1) Unless specifically stated, EN 1990, EN 1991 (all parts) and the other relevant parts of EN 1993-1 (all parts) apply. (2) The design methods given in EN 1993-1-10 are applicable if: - the execution quality is as specified in EN 1090-2 or EN 1090-4, and - the construction materials and products used are as specified in the relevant parts of EN 1993 (all parts), or in the relevant material and product specifications.
This document contains guidelines for developing and establishing policies and procedures for deletion of personally identifiable information (PII) in organizations by specifying: — a harmonized terminology for PII deletion; — an approach for defining deletion rules in an efficient way; — a description of required documentation; — a broad definition of roles, responsibilities and processes. This document is intended to be used by organizations where PII is stored or processed. This document does not address: — specific legal provision, as given by national law or specified in contracts; — specific deletion rules for particular clusters of PII that are defined by PII controllers for processing PII; — deletion mechanisms; — reliability, security and suitability of deletion mechanisms; — specific techniques for de-identification of data.
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 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.
1.1 Scope of EN 1993-1-9 (1) EN 1993-1-9 gives design methods for the verification of the fatigue design situation of steel structures. NOTE Steel structures consist of members and their joints. Each member and joint can be represented as a constructional detail or as several of the latter. (2) Design methods other than the stress-based methods, such as the notch strain method or fracture mechanics methods, are not covered by EN 1993-1-9. (3) EN 1993-1-9 only applies to structures made of all grades of structural steels and products within the scope of EN 1993-1 (all parts), in accordance with the provisions noted in the detail category tables or annexes. (4) EN 1993-1-9 only applies to structures where execution conforms to EN 1090-2. NOTE Supplementary execution requirements are indicated in the detail category tables. (5) EN 1993-1-9 applies to structures operating under normal atmospheric conditions and with sufficient corrosion protection and regular maintenance. The effect of seawater corrosion is not covered. (6) EN 1993-1-9 applies to structures with hot dip galvanizing in accordance with the provisions noted in the detail category tables or annexes. (7) Microstructural damage from high temperature (> 150°C) that occurs during the design service life is not covered. (8) EN 1993-1-9 gives guidance of how to consider post-fabrication treatments that are intended to improve the fatigue resistance of constructional details. 1.2 Assumptions (1) Unless specifically stated, EN 1990, EN 1991 (all parts) and EN 1993 1 (all parts) apply. (2) The design methods given in EN 1993-1-9 are applicable if: - the execution quality is as specified in EN 1090-2, and - the construction materials and products used are as specified in the relevant parts on EN 1993 (all parts), or in the relevant material and product specifications. (3) The design methods of EN 1993-1-9 are generally derived from fatigue tests on constructional details with large scale specimens that include effects of geometrical and structural imperfections from material production and execution (e.g. the effects of tolerances and residual stresses from welding).
1.1 Scope of EN 1993-1-13 1.1.1 General (1) This document gives supplementary provisions that extend the application of EN 1993-1-1 and EN 1993-1-5 to the design of rolled and welded steel sections with various shapes of web openings. The following cases are considered: - rolled or welded beams with single or widely spaced web openings; - rolled or welded beams with closely spaced web openings; - cellular beams with circular openings made by cutting and re-welding two parts of steel sections that may be different in dimensions; - beams with hexagonal and sinusoidal openings made by cutting and re-welding two parts of steel sections that may be different in dimensions. (2) This document applies to uniform members with I or H profiles, which are symmetric about the weak axis. It does not apply to non-prismatic or curved beams although the same principles can apply. (3) This document applies to steel beams with web openings that are subjected to sagging (positive) or to hogging (negative) bending moments. (4) This document covers the verification of the resistance at the openings and their effects on the global behaviour of the beam, including lateral torsional buckling. (5) Alternative methods are presented for beams with circular openings and with sinusoidal openings in which the forces and resistances are calculated by increments around or along the openings and which are suitable for computer methods. (6) This document applies to web slenderness, hw/tw, not exceeding 121ε. The local checks at and between adjacent openings apply to web slenderness up to this limit. The material parameter ε is defined in EN 1993-1-1:2022, 5.2.5 (2). NOTE The limit of 121ε is the limit of a Class 4 web for a steel section with equal flanges. It is used as a convenient limit for the application of this document, including mono-symmetric sections. (7) This document does not cover fatigue. In case of fatigue, EN 1993-1-9 applies. (8) This document does not cover fire design. For the design in case of fire, EN 1993-1-2 applies. (9) This document does not cover the buckling verification of members with web openings under axial force. 1.1.2 Shapes of web openings (1) The different shapes of web openings that are considered in this document are shown in Figure 1.1. Figure 1.1 - Different shapes of web openings in steel beams 1.1.3 Stiffened openings (1) This document also covers openings in the web of beams that are reinforced by longitudinal stiffeners and/or transverse stiffeners on one or both sides of the web, see Figure 1.2. NOTE The National Annex can give rules for alternative types of stiffener. Figure 1.2 - Stiffening of openings in beam webs 1.2 Assumptions (1) Unless specifically stated, EN 1990, the EN 1991 series and EN 1993-1-1 apply. (2) The design methods given in EN 1993-1-13 are applicable if: - the execution quality is as specified in EN 1090-2, and - the construction materials and products used are as specified in the relevant parts of the EN 1993 series, or in the relevant material and product specifications.
1.1 Scope of prEN 1993-1-4 This document provides supplementary rules for the structural design of steel structures that extend and modify the application of EN 1993-1-1, EN 1993-1-3, EN 1993-1-5 and EN 1993-1-8 to austenitic, duplex (austenitic-ferritic) and ferritic stainless steels. NOTE 1 Austenitic-ferritic stainless steels are commonly known as duplex stainless steels. The term duplex stainless steel is used in this document. NOTE 2 Information on the durability of stainless steels is given in Annex A. NOTE 3 The execution of stainless steel structures is covered in EN 1090-2 and EN 1090-4. 1.2 Assumptions Unless specifically stated, EN 1990, EN 1991 (all parts), EN 1993-1-1, EN 1993-1-3, EN 1993-1-5 and EN 1993-1-8 apply. The design methods given in prEN 1993-1-4 are applicable if - the execution quality is as specified in EN 1090-2 and EN 1090-4, and - the construction materials and products used are as specified in EN 1993-1-1, EN 1993-1-3, EN 1993 1-5 and EN 1993-1-8, or in the relevant material and product specifications.
This document specifies requirements and guidance for the interoperability of data, data sharing mechanisms, and services within data spaces. It covers requirements, criteria and implementation guidance on: - dataset content, use restrictions, licences, data collection methodology, data quality and uncertainty, and on machine-readable formats to find, access and use of data; - data structures, data formats, vocabularies, classification schemes, taxonomies and code lists, and how to describe these elements a publicly available and consistent manner; - technical means to access the data, such as application programming interfaces, and their terms of use and quality of service to enable automatic access and transmission of data between parties; - where applicable, the means to enable the interoperability of tools for automating the execution of data sharing contracts. This document is applicable to all organizations participating in dataspaces, regardless of their size or type.
ISO 10993-11:2017 specifies requirements and gives guidance on procedures to be followed in the evaluation of the potential for medical device materials to cause adverse systemic reactions.
Specifies methods for testing valves which are used in a circuit in order to determine their steady-state and dynamic performance. Requirements for test installations and procedures, measurements and presentation of results are specified. Does not establish limits of performance. Accuracy of measurement is divided into three classes (A, B and B) which are explained in annex A. Guidance as to the use of practical units for the presentation of results is given in annex B.
The ISO/IEC 19788 series specifies, in a rule-based manner, properties and their attributes for the description of learning resources. This includes the rules governing the identification of properties and the specification of their attributes. These properties may be used to form the description of a learning resource, i.e. as a metadata learning resource (MLR) record described in ISO/IEC 19788-8:2015 Data elements for MLR record.
This document is intended to help implementers with a starting point for adopting the ISO/IEC 19788-1:2024framework by defining an application profile that lists properties and rules, mostly taken from ISO/IEC 19788-2:2011/Amd 1:2016. In addition, it adds, as examples, three locally defined properties and one vocabulary
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 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 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.
This document is applicable to the design, information for use, maintenance and testing of power-driven winches for which the prime mover is an electric motor, hydraulic motor, or pneumatic motor. Winches are designed for the movement or manipulation of loads supported on level or inclined planes in situations where risks resulting from a failure of the winding mechanism or pulling medium are mitigated by external measures. This document is not applicable to devices which handle suspended loads. Generally, a winch is used without any additional transport movement, except in cases where a winch is used on a stranded vehicle for self-recovery of the vehicle. Applications of winches covered are for example, but not limited to: a) rope winches; b) belt winches, except steel belts used as pulling media; c) traction winches, including double capstan and traction sheave winches. These types of winches a) to c) also include the following specific applications: — vehicle recovery winches; — winches for boat trailers; — winches for stationary offshore applications. NOTE Examples are shown in Annex H. This document does not apply to: — power-driven hoists in accordance with EN 14492-2; — forestry winches in accordance with EN ISO 19472-1; — winches for seagoing vessels and mobile offshore units; — winches for the lifting of persons; — NGL building hoists in accordance with EN 14492-2; — winches for the handling of hot molten masses. This document deals with the significant hazards, hazardous situations or hazardous events relevant to power driven winches when used as intended and under conditions of misuse which are reasonably foreseeable, identified in Annex A. This document does not specify additional requirements for hazards related to the use of power driven winches in explosive atmospheres in underground mines.
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.
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 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 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.