Toimialayhteisöt

 

This document addresses symbols that may be used to convey certain items of information related to medical devices dedicated to blood collection processes and storage. The information may be required on the device itself, as part of the label, or provided with the device. Many countries require that their own language be used to display textual information with medical devices. This raises problems to device manufacturers and users. The symbols specified in this document do not replace current national regulatory requirements. Manufacturers seek to take costs out of labelling by reducing or rationalizing variants. This results in a major problem of translation, design and logistics when multiple languages are included on a single label or piece of documentation.  As other medical devices, blood medical devices, labelled in a number of different languages, can experience confusion and delay in locating the appropriate language. This document proposes solutions to these problems through the use of internationally recognized symbols with precisely defined meanings. This document is primarily intended to be used by manufacturers of medical devices dedicated to the blood collection, process storage and distribution, who market identical products in countries having different language requirements for medical device labelling. This document may also be of assistance to different stages of the blood supply chain, e.g.: distributors of blood collection devices (manual or automated) or other representatives of manufacturers; blood centres and distribution centres to simplify and secure the operating procedures. The use of these symbols is primarily intended for the medical device rather than the therapeutic product. This document does not specify requirements relating to the size and colour of symbols although the symbols specified have been specially designed so as to be clearly legible when reproduced in the space typically available on the labels of blood treatment and transfusion devices, and also so as to be suitable for on-line printing. Several of the symbols specified in this document may be suitable for application in other areas of medical technology.

 

This document specifies requirements for qualification testing of brazers and brazing operators for metallic materials. This document gives general provisions on quality requirements for brazing (see Annex A). This document applies to the following brazing processes according to ISO 857-2 and ISO 4063:2009 with local and global heating: —    911 Infrared brazing; —    912 Flame brazing, torch brazing; —    913 Laser beam brazing; —    914 Electron beam brazing; —    916 Induction brazing; —    918 Resistance brazing; —    919 Diffusion brazing; —    921 Furnace brazing; —    922 Vacuum brazing; —    923 Dip-bath brazing; —    924 Salt-bath brazing; —    925 Flux bath brazing; —    926 Immersion brazing; —    972 Arc weld brazing. This document is not applicable to personnel operating brazing equipment who do not have any direct influence on the quality of the brazed joint, for example, personnel performing exclusively loading/unloading the brazing unit or just initiating the brazing cycle in automatic brazing. The principles of this document can be applied to other brazing processes and brazing of materials not listed. This document does not apply to brazing for aerospace applications covered by ISO 11745.

 

This document gives the safety requirements and measures for table band saws and band resaws, with manual loading and/or unloading and suitable for continuous production use, hereinafter referred to as “machines”. The machines are designed to cut solid wood and material with similar physical characteristics to wood. 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 have been 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: a) device to tilt the table; b) device to tilt the saw unit. This document does not apply to: 1)    machines driven by combustion engines or power take offs (PTO); 2)    log band sawing machines; NOTE Log band sawing machines are covered by EN 1807-2:2013. 3)    horizontal band saws and band resaws; 4)    machines designed for cross-cutting of firewood. This document does not deal with hazards related to the combination of a single machine being used with any other machine (as part of a line). This document is not applicable to machines intended for use in potentially explosive atmospheres or to machines manufactured prior to the date of its publication.

 

This document specifies rules for restrained states.

 

The standard specifies a data model in UML and a derived XML schema (XSD) for defining the Level of Information Need in software applications based on concepts and principles given in Part 1, and guidance given in Part 2, in compliance with the principles and data exchange standards of data templates (ISO 23387). The standard defines the exchange format schema in XSD according to the UML schema and it gives guidelines for the usage and application of the schema. In addition, the integration with Linked Data principles and paradigms will be demonstrated.

 

This document specifies a method for the correct measurement of the colour of finished leather by instrumental means. The document describes general concepts of colour measurement adapted to leather and the calculation of differences in colour. This document defines the following: a) the use of D65 as the standard light source for the leather industry; b) the use of D65 light source 10° as standard conditions for colour matching, for the definition of daylight simulators and as the reference light source for metamerism analysis; c) the use of CIEDE2000 as the colour difference formula.

 

This document provides the part of the method to calculate the GHG emissions throughout the LNG chain specific to regasification. The general requirements are covered in ISO 6338-1.

 

This document provides the part of the method to calculate the GHG emissions throughout the LNG chain specific to shipping. The general requirements are covered in ISO 6338-1.

 

This document specifies the test conditions for the determination of the tensile properties of monolayer flat fibre reinforced plastics, based upon the general principles given in ISO 527-1. The methods are used to investigate the tensile behaviour of the test specimens and for determining the tensile strength, tensile modulus and failure strain under the defined conditions when loaded in fibre direction. The test method is suitable for use with monolayer materials made of fibre-reinforced thermoset and thermoplastic composites incorporating preimpregnated materials (prepregs). The monolayer has a unidirectional (e.g. tapes) or multidirectional (e.g. fabric) reinforcement. In case of thermoset material, the thermoset matrix needs to be able to transduce shear stresses. So, it is recommended to use specimens in cured state. The reinforcement fibres covered include glass fibres, carbon fibres, aramid fibres and other similar synthetic or natural fibres. Two methods are described (A: Reduced force clamping, B: Parallel clamping)

 

This standard defines a nomenclature for communication of information from point-of-care medical devices. Primary emphasis is placed on acute care medical devices and patient vital signs information. The nomenclature also supports concepts in an object-oriented information model that is for medical device communication.

 

This document describes in a general way the application of the soil quality TRIAD approach for the site-specific ecological risk assessment of contaminated soils. In detail, it presents in a transparent way three lines of evidence (chemistry, ecotoxicology and ecology) which together allow an efficient, ecologically robust but also practical risk assessment of contaminated soils. This procedure can also be applicable to other stress factors, such as acidification, soil compaction, salinization, loss of soil organic substance, and erosion. However, so far, no experience has been gained with these other applications. Therefore, this document focuses on soils contaminated by chemicals. NOTE 1 This document focuses on ecological risk assessment. Thus, it does not cover human health end points. In view of the nature of this document, the investigation procedure is described on a general level. It does not contain details of technical procedures for the actual assessment. However, this document includes references relating to technical standards (e.g. ISO 15799, ISO 17616) which are useful for the actual performance of the three lines of evidence. In ecological risk assessment, the effects of soil contamination on the ecosystem are related to the intended land use and the requirements that this use sets for properly functioning soil. This document describes the basic steps relating to a coherent tool for a site-specific risk assessment with opportunities to work out site-specific details. This document can also be used for the evaluation of clean-up operations, remediation processes or management measures (i.e. for the evaluation of the environmental quality after having performed such actions). NOTE 2 The application of this document starts when it has already been decided that an ecological risk assessment at a given site needs to be performed. In other words, the practical performance of the soil quality TRIAD and the evaluation of the individual test results will be described. Thus, nothing will be said about decisions whether (and if yes, how) the results of the assessment are included in soil management measures or not. NOTE 3 The TRIAD approach can be used for different parts of the environment, but this document focuses mostly on the soil compartment. Comparable documents for other environmental compartments are intended to be prepared in addition (e.g. the terrestrial aboveground compartment) in order to perform a complete site assessment, based on the same principles and processes.

 

ISO 5667-15:2009 provides guidance on procedures for the preservation, handling and storage of samples of sewage and waterworks sludge, suspended matter, saltwater sediments and freshwater sediments, until chemical, physical, radiochemical and/or biological examination can be undertaken in the laboratory. The procedures in ISO 5667-15:2009 are only applicable to wet samples of sludge, sediment and suspended matter.

 

This document specifies the general requirements on procedures for the preservation, handling and storage of samples of sewage and waterworks sludge, suspended matter, marine sediments and freshwater sediments for either chemical, physical, radiochemical, hydrobiological or microbiological examination, or all, in the laboratory. The procedures in this document are not applicable to dried samples of sludge, sediment and suspended matter. NOTE The storage conditions given do not necessarily apply for derived samples, e.g. sediment eluates or extracts. This document is not applicable to samples intended for biotesting with ecotoxicological or biological assays (which is specified in ISO 5667-16[5]) nor intended for microplastics (which is specified in ISO 5667-27[7]).

 

ISO 21734-2 defines the safety and connectivity requirements with the infrastructure for successful performance of the automated driving bus within the defined use case, and the process through which this is verified. a) definitions of operation cases for automated driving bus (ADB) b) performance requirements for successful operation of ADB with respect to ADB vehicle, infrastructure, IoT infrastructure, monitoring and management center, and bus station c) test procedures for evaluating safe operation of the ADB in cooperation with ADB system components

 

This document specifies the essential dimensional features of keystone rings made of steel, types T, TB, TBA, TM, K, KB, KBA and KM, having diameters from 70 mm up to and including 160 mm, used in reciprocating internal combustion piston engines.

 

This document specifies the essential dimensional features of keystone rings made of cast iron, types T, TB, TBA, TM, K, KB, KBA and KM, having diameters from 70 mm up to and including 200 mm, used in reciprocating internal combustion piston engines.

 

 

This document supports evaluation of the accuracy, secrecy, and privacy of biometric template protection schemes. It establishes definitions, terminology, and metrics for stating the performance of such schemes. Particularly, this document establishes requirements for the measurement and reporting of: — theoretical and empirical accuracy of biometric template protection schemes, — theoretical and empirical probability of a successful attack on biometric template protection schemes (single or multiple), and — the biometric information leaked when one or more biometric template protection schemes are compromised. This document also gives guidance on measuring and reporting diversity and unlinkability of templates. This document does not: — establish template protection schemes; — address testing of traditional encryption schemes.

 

This document specifies basic requirements for the design, layout and application of boom accessories, referred to as auxiliary equipment for the purpose of this document. This document does not purport to address all safety concerns, if any, associated with its use. However, it is the responsibility of the user of this document to establish the appropriate safety and health procedures, and to determine the applicability of regulatory limitations.

 

This document specifies a test method for measuring the forces needed for the placement and removal of dental attachments (frictional retention elements of ball head-, snap-on, prefabricated telescopic and bar systems used for the attachment, support and stabilization of crowns and bridges, single attachments, removable partial dentures, complete dentures, and other superstructures on dental implant systems (including monopart implants) and, if not other justified, on natural teeth and root post copings). If not otherwise justified, this document can also be used for tests on custom-made or patient matched devices (e.g. laboratory manufactured). This test method is not applicable to retention devices for which normal placement and removal requires any off-axis rotation for the path of least resistance. This test method is not applicable to dental magnetic attachments, these are specified in ISO 13017.