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This document specifies:
— the general principles governing the biological evaluation of medical devices within a risk management process;
— the general categorization of medical devices based on the nature and duration of their contact with the body;
— the evaluation of existing relevant data from all sources;
— the identification of gaps in the available data set on the basis of a risk analysis;
— the identification of additional data sets necessary to analyse the biological safety of the...view more

IEC 60384-13:2020 specifies preferred ratings and characteristics, selects from IEC 60384-1:2016 the appropriate quality assessment procedures, tests and measuring methods, and gives general performance requirements for this type of capacitor. Test severities and requirements specified in detail specifications referring to this sectional specification are of an equal or higher performance level. Lower performance levels are not permitted. This part of IEC 60384 applies to fixed direct current ca...view more

This document applies to medical devices other than in vitro diagnostic medical devices manufactured utilizing materials of animal origin, which are non-viable or have been rendered non-viable. It specifies, in conjunction with ISO 14971, a procedure to identify the hazards and hazardous situations associated with such devices, to estimate and evaluate the resulting risks, to control these risks, and to monitor the effectiveness of that control. Furthermore, it outlines the decision process for ...view more

IEC 63193:2020 is applicable to lead-acid batteries powering electric two-wheelers (mopeds) and three-wheelers (e-rickshaws and delivery vehicles), and also to golf cars and similar light utility and multi-passenger vehicles. The document specifies methods of tests tailored to batteries destined for the above‑referenced types of vehicles so as to ensure satisfactory and safe battery performance in the intended application. This document does not apply for example to lead-acid cells and batteries...view more

TAN - // IEC Corrigendum

IEC 63056:2020 specifies requirements and tests for the product safety of secondary lithium cells and batteries used in electrical energy storage systems (Figure 2) with a maximum DC voltage of 1 500 V (nominal). Basic safety requirements for the secondary lithium cells and batteries used in industrial applications are included in IEC 62619. This document provides additional or specific requirements for electrical energy storage systems. Since this document covers batteries for various electrica...view more

IEC 63057:2020 specifies safety tests and requirements for secondary lithium batteries permanently installed in road vehicles not for the propulsion. Replacement secondary batteries permanently installed in road vehicles not for propulsion are covered by this document. The following are typical applications that utilize the batteries under the scope of this document: a power source for the starting of internal combustion engines, lighting, on-board auxiliary equipment, and energy absorption for ...view more

REN/ERM-TGMAR-604

2017-05-12: ISO WI (ID 55336) again deleted and replaced by new ISO WI (ID 73457). ISO/TC 188 information to dataservice on 2017-05-12)

This document specifies procedures and requirements for the transfer of bunkers to vessels by bunker tankers using the Coriolis mass flow meter (MFM) system. It encompasses the process leading to the approval of the MFM system as installed on bunker tankers and post-approval bunkering operation. It covers terminology, specifications, requirements and procedures on metrology, system integrity, metering system selection and installation, MFM system verification, bunker delivery and dispute handlin...view more

This document focuses on monitoring the activity concentrations of radioactive gases. They allow the calculation of the activity releases, in the gaseous effluent discharge from facilities producing positron emitting radionuclides and radiopharmaceuticals. Such facilities produce short-lived radionuclides used for medical purposes or research and can release gases typically including, but not limited to 18F, 11C, 15O and 13N. These facilities include accelerators, radiopharmacies, hospitals and ...view more

This document describes the serialization of the lexical markup framework (LMF) model defined as an XML model compliant with the Text Encoding Initiative (TEI) Guidelines. This serialization covers the classes of ISO 24613-1 (the LMF core model) as well as classes provided by ISO 24613-2 (the machine readable dictionary, MRD, model) and ISO 24613-3 (the etymological extension).

IEC 60794-1-2:2021 is available as IEC 60794-1-2:2021 RLV which contains the International Standard and its Redline version, showing all changes of the technical content compared to the previous edition.IEC 60794-1-2:2021 applies to optical fibre cables for use with telecommunications equipment and devices employing similar techniques, and to cables having a combination of both optical fibres and electrical conductors. An objective of this document is to define general requirements and methodolo...view more

This document gives guidelines for the development of multi-operator/multi-service interoperable public surface (including subways) transport fare management systems (IFMSs) on a national and international level. This document is applicable to bodies in public transport and related services which agree that their systems need to interoperate. This document defines a conceptual framework which is independent of organizational and physical implementation. Any reference within this document to orga...view more

This document: — provides risk management elaborations for the processes described in ISO/IEC/IEEE 15288 and ISO/IEC/IEEE 12207, — provides the users of ISO/IEC/IEEE 15288, ISO/IEC/IEEE 12207 and their associated elaboration standards with common terminology and specialized guidance for performing risk management within the context of systems and software engineering projects, — specifies the required information items that are to be produced through the implementation of risk management process...view more

IEC TS 62282-9-102:2021 provides a set of specific rules, requirements and guidelines (i.e. so-called product category rules (PCR) according to ISO 14025 and thus in line with ISO 14040 and ISO 14044) for characterizing the environmental performance of stationary fuel cell combined heat and power (CHP) systems, and alternative systems for residential applications based on life cycle thinking primarily for communication to consumers.
This document covers stationary fuel cell CHP systems and alte...view more

IEC TR 61188-8:2021(E) describes the configuration of part shape data of semiconductor devices and electrical components registered in the CAD library. This document mainly describes the configuration of 2D and 3D parts shape data.

This document specifies minimum nuclear criticality safety training requirements for operations staff, operations supervisors, and management. This document is applicable to areas, processes or facilities containing quantities of fissile material for which nuclear criticality safety assessment is required as defined in ISO 1709. This document is not applicable to the transport of fissile materials outside the boundaries of nuclear establishments.

This document describes sample methods to generate spectra for colour targets comprised of highly saturated colours for colour characteristic evaluation of colorimetric image capture capability of digital still cameras (DSCs).