Toimialayhteisöt

 

This document specifies the requirements and methods for the clinical investigation of me equipment used for the intermittent non-invasive automated estimation of the arterial blood pressure by utilizing a cuff. This document is applicable to all sphygmomanometers that sense or display pulsations, flow or sounds for the estimation, display or recording of blood pressure. These sphygmomanometers need not have automatic cuff inflation. This document covers sphygmomanometers intended for use in all patient populations (e.g. all age and weight ranges), and all conditions of use (e.g. ambulatory blood pressure monitoring, stress testing blood pressure monitoring and blood pressure monitors for the home healthcare environment for self-measurement as well as use in a professional healthcare facility). EXAMPLE Automated sphygmomanometer as given in IEC 80601-2-30 undergoing clinical investigation according to this document. This document specifies additional disclosure requirements for the accompanying documents of sphygmomanometers that have passed a clinical investigation according to this document. This document is not applicable to clinical investigations of non-automated sphygmomanometers as given in ISO 81060-1 or invasive blood pressure monitoring equipment as given in IEC 60601-2-34. This document is not applicable to clinical investigations of a set of cuffs that are not of same materials and construction. Each type of cuff set is required to be evaluated separately according to this document.

 

 

 

Standardi koskee audiovisuaalisiin eli ääntä ja kuvaa sisältäviin materiaaleihin tehtäviä käännöstekstityksiä. Käännöstekstityksiä tehdään esimerkiksi televisioon, suoratoistopalveluihin ja elokuvateatterilevitykseen sekä yritysten, järjestöjen, instituutioiden ja laitosten tuottamiin tai levittämiin videoihin.

 

Standardi koskee soveltuvin osin myös muuta av-kääntämistä, kuten dubbaus- ja selostuskääntämistä, pelikäännöksiä sekä teatteri- ja oopperaesityksiin esityspaikalla suorana ajastettavia käännöstekstityksiä. Standardi ei koske ohjelmatekstityksiä eikä kuvailutulkkausta.

 

Standardi on tarkoitettu kotimaiseen käyttöön, eikä sitä ole sidottu mihinkään tiettyyn kielipariin. Standardi on tarkoitettu sovellettavaksi Suomeen suunnattuihin tai Suomessa tuotetuista materiaaleista tehtyihin käännöstekstityksiin.

 

Standardi on tarkoitettu av-käännösalalla toimiville yrityksille ja organisaatioille sekä niiden asiakkaille.

 

 

 

This document specifies a means for communicating, or preserving as an archive, part or all of the electronic health record (EHR) of one or more identified subjects of care between EHR systems, or between EHR systems and a centralised EHR data repository . It can also be used for EHR communication between an EHR system or repository and clinical applications or middleware components (such as decision support components), or personal health applications and devices, that need to access or provide EHR data, or as the representation of EHR data within a distributed (federated) record system. This document will predominantly be used to support the direct care given to identifiable individuals or self-care by individuals themselves, or to support population monitoring systems such as disease registries and public health surveillance, animals, and events such as pollution, poisons, etc. . Uses of health records for other purposes such as teaching, clinical audit, administration and reporting, service management, research and epidemiology, which often require anonymization or aggregation of individual records, are not the focus of this document but such secondary uses might also find the document useful. This document is an Information Viewpoint specification as defined ISO/IEC 10746-1 [3]. This document is not intended to specify the internal architecture or database design of EHR systems.

 

 

This document comprises multiple human and machine-readable resources with different roles that together define a vocabulary for representing some spatial information according to a data model and extensions to a query language for accessing that information. See the Introduction section 0.4 for details of the parts. It does not define a comprehensive vocabulary for representing all spatial information: it only defines a core set of classes, properties and datatypes that can be used to construct query patterns. Many useful extensions to this vocabulary are possible, and we intend for the Semantic Web and Geospatial communities to develop additional vocabularies for describing spatial information.

 

This document specifies dimensional requirements for base-mounted in-line fuel injection pumps and high-pressure supply pumps for common rail fuel injection systems for diesel (compression-ignition) engines.

 

This document specifies the requirements for the design, construction and installation of the following types of DC and AC electrical systems, installed either individually or in combination, for all small craft operational states and environmental locations: a) craft low voltage direct current (DC) electrical systems where the highest voltage of a system does not exceed 60 V DC; b) single-phase alternating current (AC) systems that operate at an RMS voltage not exceeding 250 V AC. NOTE In Europe, 230 V AC single-phase systems are either polarized and unpolarized. In North America, 120/240 V AC split-phase systems are a variation of a 3-wire single-phase system. The 120 V AC systems are wired polarized while the 240 V AC systems are wired unpolarized. Regarding this standard, 250 V AC is rounded up to ensure variations in 240 V AC are included. This document does not cover the following: — electrical propulsion systems of direct current less than 1 500 V DC, single-phase alternating current up to 1 000 V AC, and three-phase alternating current up to 1 000 V AC, which are addressed by ISO 16315 [1]. — any conductor that is part of a factory-built assembly and that does not extend beyond the assembly such as network cables, engines and engine management systems. — three-phase AC installations that operate at a nominal voltage not exceeding 500 V AC, which are addressed byIEC 60092-507 [2]. craft-high voltage direct current (DC) systems where the highest voltage of a systems exceeds 60 V DC and does not exceed 1 500 V DC. shore power connection for general power supply and battery charging, which are not addressed by IEC 60309-2 [3]. electromagnetic compatibility (EMC) test methods and requirements.lithium-ion batteries which are addressed by ISO 23625 [4]

 

This document provides guidance on managing an information security management system (ISMS) audit programme, on conducting audits, and on the competence of ISMS auditors, in addition to the guidance contained in iso:proj:88984ISO/FDIS 19011. This document is applicable to those needing to understand or conduct internal or external audits of an ISMS or to manage an ISMS audit programme.

 

 

This document specifies general requirements for evaluating the interactions of medical devices with blood. It describes a) a classification of medical devices that are intended for use in contact with blood, based on the intended use and duration of contact as defined in ISO 10993-1, b) the fundamental principles governing the evaluation of the interaction of devices with blood, c) the rationale for structured selection of tests according to specific categories, together with the principles and scientific basis of these tests. Detailed requirements for testing cannot be specified because of limitations in the knowledge and precision of tests for evaluating interactions of devices with blood. This document describes biological evaluation in general terms and may not necessarily provide sufficient guidance for test methods for a specific device.

 

 

This document defines various terms relating to the design, construction, primary packaging and testing of fireworks of categories F1, F2 and F3 as defined by Article 6 Paragraph (1) clause (a) subclause (i) to (iii) of Directive 2013/29/EU. It gives descriptions of fireworks types and establishes a system for categorization. Minimum labelling requirements for fireworks as well as for primary and selection packs of fireworks are specified. Firework specific test methods are defined. Specifications of requirements for construction and performance of firework, primary packs and selection packs complete this standard. This standard does not apply to fireworks intended to be kept or used at temperatures below -20 °C or above 50 °C.

 

This document provides specific safety requirements for the design and use of personal light electric vehicles totally or partially electrically powered from self-contained power sources for domestic and commercial use. This document applies to personal light electric vehicles with maximum speed up to 25 km/h. This document applies to personal light electric vehicles without self-balancing system totally or partially electrically powered from self-contained power sources having battery voltages up to 100 VDC, with or without an integrated battery charger with up to a 240 VAC input. This document specifies safety requirements, test methods, marking and information relating to personal light electric vehicles to reduce the risk of injuries to both third parties and the user during intended use, i.e. when used as intended and under conditions of misuse that are reasonably foreseeable by the manufacturer. This document provides specific prescription to assess the safety of personal light electric vehicles intended for leisure activities. This document provides a recommended method to assess the performance of personal light electric vehicles totally or partially electrically on: total run time (battery run time). This document does not apply to: — vehicles that are considered as toys; — vehicles with self-balancing system; — vehicles with seating position; — vehicles without handle bar; — vehicles intended for competition; — electrically powered assisted cycles (EPAC); — vehicles and/or devices intend for use for medical care; — electric vehicles having a maximum design speed above 25 km/h; — vehicles having a rated voltage of more than 100 VDC or 240 VAC; — vehicles without an on-board driving operator; — vehicles intended for the transport of goods and other services. NOTE 1 See D.2. NOTE 2 The local regulation could limit the use of the vehicle to a speed lower than 25 km/h.

 

This document specifies the requirements for the design, construction and installation of the following types of DC and AC electrical systems, installed on small craft either individually or in combination: a) extra-low-voltage direct current (DC) electrical systems that operate at nominal potentials of 50 V DC or less; b) single-phase alternating current (AC) systems that operate at a nominal voltage not exceeding AC 250 V. This document does not cover the following: — electrical propulsion systems of direct current less than 1 500 V DC, single-phase alternating current up to 1 000 V AC, and three-phase alternating current up to 1 000 V AC, which are addressed by ISO 16315; — any conductor that is part of an outboard engine assembly and that does not extend beyond the outboard engine manufacturers supplied cowling; — three-phase AC installations that operate at a nominal voltage not exceeding 500 V AC, which are addressed by IEC 60092-507.

 

This document specifies requirements, test methods and performance criteria for factory-applied polymer coatings applied to the internal and external surfaces of steel pipes intended for use in fixed water-based fire-fighting systems designed in accordance with the EN 12845 series of standards. This document specifies requirements for the polymer coating when used as a corrosion-protection system. The mechanical and functional characteristics of the steel pipes and pipe systems are outside the scope of this document and are as specified in the EN 12845 series. NOTE Throughout this document, the term "coating" refers exclusively to factory-applied polymer coatings unless otherwise specified.

 

This document provides guidance on the description of soil in the field and its environmental context. It is applicable to natural, near-natural, urban and industrial sites. The soil observations and measurements can be made on a project site level, on a plot level, on layer or horizon level and on specific soil constituents. It also provides guidance on how to describe layers of anthropogenic (artificial) material or layers that were not modified by pedogenic processes in the strict sense and how to describe coarse material of natural or artificial origin. This document can be used in combination with other publications that provide guidance or requirements regarding specific aspects of soil observations and measurements. NOTE 1 It might not be possible or necessary to record data under all the headings listed in Clauses 4 to 11. NOTE 2 Overall guidance for presentation of information from soil surveys is given in ISO 15903. NOTE 3 The guidance provided assumes that sampling will be done in accordance with ISO 18400.

 

This part of the EN 1366 series specifies a method of test and criteria for the evaluation (including field of direct application rules) of the ability of a partial penetration seal to maintain the fire resistance of a separating element at the position at which it has been penetrated by a device or devices that passes through one face of the element only. Partial penetration seals are used to seal apertures for electrical sockets, downlighters, media devices, cables and any item which requires an opening to be made in one face of the element of construction but does not include a device which passes through both faces. Supporting constructions are used in this part of the EN 1366 series to represent separating elements such as walls or floors. The supporting construction shall be a system that has been subject to a fire test in accordance with one of the following standards: EN 13381 1 for horizontal membranes, EN 13381 2 for vertical membranes, EN 1364 1 or EN 1365 1 for walls, EN 1366 3 for walls based on a standard supporting construction, or EN 1364 2 or EN 1365 2 for floors. This is referred to throughout this document as the applicable test standard for the supporting construction. This part of the EN 1366 series is used in conjunction with EN 1363 1. The purpose of a test described in this part of the EN 1366 series is to assess the integrity and insulation performance of the partial penetration seal, of the partially penetrating service(s) or device(s) and of the separating element in the surrounding area of the partial penetration seal. Where partial penetration seals are installed in loadbearing elements, it is possible that the loadbearing capacity is also considered. It is not the intention of this test to provide quantitative information on the rate of leakage of smoke and/or hot gases or on the transmission or generation of fumes. Tests in accordance with this part of the EN 1366 series are not intended to supply any information on the ability of the partial penetration seal to withstand stress caused by movements or displacements of the penetrating devices. The risk of spread of fire downwards cannot be assessed with this test. Tests in accordance with this part of the EN 1366 series do not address any risks associated with leakage of dangerous liquids or gases caused by failure of the device in case of fire.