Ämnesområden

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 specifies and classifies the component/product performance characteristics, which may be necessary for the design, rating and dimensioning, placing on the market of residential ventilation products and systems to provide the predetermined performance, comfort conditions of temperature, air velocity, humidity, hygiene and sound in the occupied zone. It defines those performance characteristics (mandatory or optional) which are determined, measured and presented according to relevant test methods. It provides a classification scheme, which leads to a full definition of product properties based on test methods described in various European Standards, and gives an overview of the test standards. Distinction between mandatory and optional requirements is left to each European and national regulation(s). The codification part in Annex B and the classification part in Clause 8 apply to the following products: - unidirectional mechanical supply and exhaust residential ventilation units according to EN 13141-4:2021 and EN 13141-6:2014; - ducted mechanical bidirectional residential ventilation units according to EN 13141-7:2021; - non-ducted mechanical bidirectional residential ventilation units according to EN 13141-8:2022. This document does not apply to other products such as filters, fire dampers, ducts, control devices and sound attenuators, which may also be incorporated in residential ventilation. This document specifies in Annex ZA and Annex ZB the requirements of EU 1253/2014 and EU 1254/2014 for residential ventilation units below 1 000 m3/h air volume flow. This document does not cover requirements raised by European Directives (e.g. low voltage directive, EMC directive) and other requirements such as corrosion, reaction to fire and snow penetration.

This document specifies requirements and recommendations for the design, preparation and application of - renders based on cement, lime or other mineral binders, and/or combinations thereof, masonry cement and polymer modified binder based external renderings, in accordance with EN 998-1 or site made renders; - renders based on organic binders in accordance with EN 15824 on all common types of backgrounds. It includes rendering on both new and old backgrounds and the maintenance and repair of existing work. This document gives guidance on the use of established site, factory and semi-finished factory-made renders. This document does not cover the following: a) the use and application of special renders for liquid retaining structures, e.g. coatings, and for backgrounds to cladding systems; b) the structural repair of concrete; c) the installation of external thermal insulation composite systems (ETICS); d) the specification and use of sealants used to seal joints for use with rendering; e) the use of gypsum-based renders; f) renders on historical monuments or buildings in protected areas; g) the design and installation of flashings at windowsills and elsewhere. Because of the many varied materials, practices and different climatic conditions, it is not possible for certain aspects of the standard to enter into sufficient detail to be fully usable by all practitioners. NOTE Local or national regulations take precedence when applicable.

This document deals with the design considerations and essential principles for internal plastering systems and application of plastering systems. The different parts of the EN 13914 series of standards specify requirements and recommendations for detailing, design and material considerations, the selection of mixes and the application of gypsum plasters, gypsum/lime plasters, lightweight plasters, lime/gypsum-, cement- and cement/lime-based plasters, lime-based plasters, clay plasters, silicate plasters, organic plasters, polymer-modified plasters, etc. This document does not deal with the following: - external finishes; - painting and/or preparation; - impregnations; - structural repair of concrete; - prefabricated fibre-reinforced plaster elements; - surface treatments. Because of the many varied materials, practices and different climatic conditions, it is not possible for certain aspects of the standard to enter into sufficient detail to be fully usable by all practitioners. NOTE Local or national regulations take precedence when applicable.

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 specifies the requirements and test methods for sterilized absorbent points used in endodontic procedures. Absorbent points are marketed sterilized or non-sterilized. The requirements apply to absorbent points which have been sterilized once in a manner approved by the manufacturer. This document specifies numerical systems and a colour-coding system for designating the sizes of absorbent points. Clause 7 specifies the labelling and packaging needed, including the instructions for use. A claim by the manufacturer that the contents of the unopened pack are sterile is the responsibility of the manufacturer (see Table 2). This document does not specify requirements or test methods for sterility. NOTE 1 Reference to applicable national regulations can be made. Reference is made to internationally accepted pharmacopoeia. NOTE 2 National requirements can apply. Standards on methods of validating sterilization processes are also available: ISO 11137-1, ISO 11137-2 and ISO 11137-3.

This document gives the safety requirements and measures for four-sided moulding machines, capable of continuous production use, with a maximum working width of 350 mm and a maximum speed of the integrated workpiece feed of 200 m/min, hereinafter referred to as “machines”, designed to cut solid wood and materials with similar physical characteristics to wood (see ISO 19085-1:2021, 3.2). It deals with all significant hazards, hazardous situations and events, listed in Annex A, relevant to the machines, when operated, adjusted and maintained as intended and under the conditions foreseen by the manufacturer; reasonably foreseeable misuse has been considered too. Also, transport, assembly, dismantling, disabling and scrapping phases are taken into account. It is also applicable to machines fitted with one or more of the following devices / additional working units, whose hazards have been dealt with: —   universal spindle; —   glass bead saw unit; —   fixed or movable workpiece support; —   quick tool changing system; —   laser marking unit; —   automatic workpiece returner; —   in-feed hopper; —   loading magazine; —   unloading table. This document does not deal with any hazards related to: a) in-feed devices other than in-feed hopper and loading magazine; NOTE 1     For mechanical in-feed devices which also prevent access to the in-feed opening, see 6.6.4. b) out-feed devices other than unloading table, except for hazards related to ejection from the machine due to climb cutting; c) out-feed of workpieces on machines with feed speed higher than 60 m/min; NOTE 2     Machines with feed speed higher than 60 m/min are usually combined with mechanical unloading and workpiece transfer systems. d) machines being used in combination with any other machine (as part of a line). It is not applicable to machines intended for use in potentially explosive atmosphere and to machines manufactured prior to its publication.

This document gives the safety requirements and measures for edge banding machines fed by chains or belts, with manual loading and unloading and maximum workpiece height capacity of 100 mm, capable of continuous production use, hereinafter referred as “machines”. It deals with all significant hazards, hazardous situations and events, listed in Annex A, relevant to the machines, when operated, adjusted and maintained as intended and under the conditions foreseen by the manufacturer; reasonably foreseeable misuse has been considered too. Also, transport, assembly, dismantling, disabling and scrapping phases are taken into account. The machines are designed to process in one pass one end (single-end machine) or both ends (double-end machine) of panels of: —   materials with similar physical characteristics to wood (see ISO 19085-1:2021, 3.2), even with a core sheet of aluminium light alloy; —   gypsum plaster boards. Edges to be applied by the machine can be made of: —   paper; —   melamine; —   plastic; —   composite materials; —   aluminium; —   light alloy; —   veneer; —   solid wood. It is also applicable to machines fitted with one or more of the following devices/working units, whose hazards have been dealt with: —   hot air banding unit; —   laser banding unit; —   infrared banding unit; —   dynamic processing units; —   sanding belt units; —   milling unit installed out of the integral enclosure at the panel side on single-end machines; —   milling unit installed out of the integral enclosure between machines halves of double-end machines; —   additional fixed or movable workpiece support along the feed; —   additional infeed workpiece support; —   additional outfeed workpiece support; —   in-feed device for transversal loading of panels in single-end machines; —   intermediate workpiece support in double-end machines; —   automatic panel returner in single-end machines; —   automatic tool changing; —   quick tool changing system; —   automatic multiple edges infeed device; —   workpiece heaters. This document does not deal with any hazards relating to: a)  systems for loading and unloading of the workpiece to a single machine other than automatic panel returner and infeed and outfeed workpiece supports (e.g. robots); b)  the combination of a single machine being used with other machines (as part of a line); c)  workpiece dividing unit installed out of the integral enclosure and/or whose tools protrude out of the integral enclosure; d)  plasma banding unit. It is not applicable to machines intended for use in potentially explosive atmosphere nor manufactured before the date of its publication.

ISO 12625-8:2010 specifies a basket-immersion test method for the determination of water-absorption time and water-absorption capacity of tissue paper and tissue products. It is expressly stated that the detection of impurities and contraries in tissue paper and tissue products be applied according to ISO 15755. For the determination of moisture content in tissue paper and tissue products, ISO 287 is applicable.

ISO 10519:2015 specifies a spectrometric method for the determination of the chlorophyll content of rapeseed. It is not applicable to the determination of chlorophyll in oils.