Normy

Obsah

ČSN ETSI EN 302 537 V2.1.1 The present document applies to ultra low power systems and accessories operating in spectrum within the bands 401 MHz to 402 MHz and 405 MHz to 406 MHz that operate in a MEDS service for telecommand and telemetry between devices that are part of a MEDS (see definition of MEDS); 1) Only two types of MEDS system devices are permitted under the present document: 2) Frequency agile devices designed to access a minimum of 18 channels evenly distributed across the 401 MHz to 402 MHz and 405 MHz to 406 MHz bands with a minimum of 9 channels for each 1 MHz segment (i.e. 401 MHz to 402 MHz and 405 MHz to 406 MHz). Devices capable of operation only on a single channel using low duty cycle and low power for spectrum access in the 401 MHz to 402 MHz or 405 MHz to 406 MHz bands, see clause 4.2.3.1.2 and the following clauses. The frequency usage conditions for the bands 401 MHz to 402 MHz and 405 MHz to 406 MHz are European wide harmonised for "active medical implant devices" according to Commission Implementing Decision 2013/752/EU [i.12] and ERC Decision (01)17 [i.1] with the following usage restrictions: " "This set of usage conditions is only available for systems specifically designed for the purpose of providing non-voice digital communications between active implantable medical devices and/or body-worn devices and other devices external to the human body used for transferring non-time critical individual patient-related physiological information." The present document covers devices utilizing ultra low power radio devices in combination with medical devices, the medical portion of which is regulated by the Medical Device Directive [i.8] (MDD) or the Active Implantable Medical Device Directive (AIMD [i.9]). The radio part of medical devices regulated by the MDD is hereafter referred to as ULP-AMD, ULP-AMD-P for peripheral devices, and ULP-BWD for body worn devices. ULP-BWD are devices, such as a physiological parameter sensor or handheld devices that are intended to operate in very close proximity to the human body, including touching the body, whose radio antenna is external to the body and is used to communicate with a device that is part of a MEDS system. The radio part of medical devices regulated under the AIMD is hereafter referred to as Ultra Low Power-Active Medical Implants (ULP-AMI) and peripherals (ULP-AMI-P) used in a Medical Data Service (MEDS). Devices covered by the present document are an evolving new technology to be made available worldwide by the medical equipment industry that will provide high speed communications capability between devices associated with an individual patient that are part of a complete MEDS system as defined in clause 3.1. Examples of MEDS devices falling under the scope of the present document are portable body worn physiological sensors that allow ambulatory monitoring, implanted devices and external system devices used to transfer data collected by a MEDS system to medical practitioners that will use the data to diagnose and treat a patient. The present document contains requirements to demonstrate that Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz ". shall be so constructed that they both effectively use and support the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU [i.2]). It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable.

Obsah

ČSN EN 60154-2 ed. 2 Tato norma specifikuje rozměry přírub pro normální pravoúhlý vlnovod používaný v elektronických zařízeních. Pokrývá požadavky na příruby vrtané před nebo po namontování na vlnovody. Pro optimální elektrickou funkčnost se doporučuje vyvrtat naváděcí otvory dodatečně po montáži. Cílem této normy je specifikovat pro vlnovodové příruby mechanické požadavky nutné pro zajištění kompatibility a, pokud je to možné, i zaměnitelnosti, a rovněž pro zajištění odpovídající elektrické funkčnosti.

Obsah

ČSN EN 60601-2-24 ed. 2 Toto druhé vydání nahrazuje první vydání ČSN EN 60601-2-24 z roku 1999. Norma je přizpůsobena skladbě a názvosloví obecné normy ČSN EN 60601-1 ed. 2 z července 2007 a její orientaci na využívání procesu řízení rizika u zdravotnických elektrických přístrojů a na jejich nezbytnou funkčnost. Nové je zahrnutí problematiky použitelnosti a alarmů. Norma platí předně pro základní bezpečnost a nezbytnou funkčnost infuzních pump a volumetrických regulátorů infuze. Platí ale také pro infuzní soupravy, pokud jejich charakteristiky ovlivňují základní bezpečnost nebo nezbytnou funkčnost infuzních pump a volumetrických regulátorů infuze. Tato norma však nespecifikuje požadavky nebo zkoušky jiných hledisek infuzních souprav. Norma specifikuje požadavky na enterální nutriční pumpy, infuzní pumpy, ambulantní infuzní pumpy, stříkačkové nebo kontejnerové pumpy, volumetrické regulátory infuze a volumetrické infuzní pumpy. Norma neplatí pro prostředky specificky určené pro diagnostiku nebo podobné použití (například angiografické nebo jiné pumpy, trvale ovládané nebo kontrolované obsluhou); prostředky pro mimotělní krevní oběh; implantabilní prostředky; zdravotnické elektrické přístroje specificky určené pro diagnostické použití v urodynamice (měření vzájemných závislostí tlaku a objemu v močovém měchýři, plněném vodou pomocí katetru); zdravotnické elektrické přístroje specificky určené pro diagnostické použití při testování mužské impotence (měření množství infuzní kapaliny nezbytné k dosažení předvolené hladiny tlaku pro udržení erekce penisu: kavernózometrie, kavernózografie); prostředky pro které platí ISO 28620.

Obsah

ČSN EN 14309 Tato harmonizovaná norma specifikuje požadavky na průmyslově vyráběné výrobky z pěnového polystyrenu, které jsou používány pro tepelnou izolaci zařízení budov a průmyslových instalací v rozsahu provozní teploty od přibližně -180 °C do +80 °C. Tato norma zahrnuje také pěnový polystyren z modifikovaných polymerů s vyšší odolností proti vysokým teplotám. Výrobky jsou vyráběny ve formě desek s/nebo bez opláštění, ve formě rolí, izolačních segmentů, izolačních pouzder potrubí nebo jiných prefabrikovaných výrobků. Proti předchozímu vydání byla do normy zapracována ustanovení nařízení pro stavební výrobky CPR.

Obsah

ČSN EN ISO 16911-2 EN ISO 16911-2 stanoví požadavky na automatizované měřicí systémy (AMS) pro měření průtoku. Částečně je odvozena z EN 14181, což je obecný dokument prokazování kvality AMS a používá se společně s tímto dokumentem. EN ISO 16911-2 stanoví podmínky a měřítka pro výběr, instalaci, převzetí a kalibraci AMS použitých pro měření průtoku odpadních plynů ze zdroje. EN ISO 16911-2 lze použít v korelaci s manuální referenční metodou uvedenou v EN ISO 16911-1. EN ISO 16911-2 je vyvinuta hlavně pro měření emisí ze spaloven odpadů a pro velké spalovací zdroje. Z technického hlediska ji lze použít i pro ostatní procesy, kde se požaduje určení minimální nejistoty měření průtoku.

Obsah

ČSN ETSI EN 300 396-6 V1.6.1 The present document defines the Terrestrial Trunked Radio system (TETRA) Direct Mode of operation. It specifies the basic Air Interface (AI), the interworking between Direct Mode Groups via Repeaters and interworking with the TETRA Trunked system via Gateways. It also specifies the security aspects in TETRA Direct Mode and the intrinsic services that are supported in addition to the basic bearer and teleservices. The present document describes the security mechanisms in TETRA Direct Mode. It provides mechanisms for confidentiality of control signalling and user speech and data at the AI. It also provided some implicit authentication as a member of a group by knowledge of a shared secret encryption key. The use of AI encryption gives both confidentiality protection against eavesdropping, and some implicit authentication.

Obsah

ČSN ETSI EN 300 674-2-1 V2.1.1 The present document applies to Transport and Traffic Telematics (TTT) systems: - with a Radio Frequency (RF) output connection and specified antenna or with an integral antenna; - for data transmission only; - operating on radio frequencies in the 5,725 GHz to 5,875 GHz Short Range Devices frequency band. The applicability of the present document covers only the Road Side Units (RSU). The present document does not necessarily include all the characteristics which may be required by a user, nor does it necessarily represent the optimum performance achievable. The present document complies with the Commission Implementing Decision 2013/752/EU [1] and CEPT/ERC Recommendation 70-03 [2]. It is a specific standard covering various TTT applications. The present document contains requirements to demonstrate that radio equipment both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference.

Obsah

ČSN ETSI EN 302 064 V2.1.1 The present document applies to terrestrial wireless digital video link equipment operating in the frequency band 1,3 GHz to 50 GHz. The present document contains requirements to demonstrate that radio equipment both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference.

Obsah

ČSN ETSI EN 302 065-4 V1.1.1 The present document specifies the requirements for material sensing applications using UWB technology operating in all or part of the frequency band from 2,2 GHz to 8,5 GHz. Additionally, it specifies reduced emissions in the ranges from 0,96 GHz to 2,2 GHz and 8,5 GHz to 10,6 GHz. The present document applies to: 1) Material Sensing devices: a device enabling radio determination application designed to detect the location of objects within a structure or to determine the physical properties of a material. 2) Equipment fitted with a non-user changeable antenna. 3) The main categories are: a) Non fixed material sensors; b) Non fixed building material sensors; c) Fixed material sensors. The present document does not apply to: - UWB communication devices; - Ground and wall probing radar devices; - Through-wall radar imaging devices; and - (Tank) Level Probing devices. Equipment covered by the present document operates in accordance with ECC/DEC(07)01 [i.7] and Commission Decision 2014/702/EU [i.12].

Obsah

ČSN ETSI EN 301 559 V2.1.1 The present document covers, for Low Power Active Medical Implants (LP-AMI) using the band bands 2 483,5 MHz to 2 500 MHz, and associated Peripherals (LP AMI P) used in an Active Medical Implant Communications System (AMICS), the required characteristics considered necessary to efficiently use the available spectrum and serve the interests of patients with implanted devices. The specifications contained in the present document were developed to ensure that the health and safety of the patients that are using this equipment under the direction of medical practitioners is protected. Of particular importance is the inclusion of spectrum monitoring and access requirements designed to significantly reduce any interference potential between AMICS operating in the band or between AMICS and other primary or secondary users of the band. An AIMD is regulated under the AIMD Directive 90/385/EEC [i.5] radio parts contained therein (referred to herein as LP-AMI and LP-AMI-P for associated peripheral devices) are regulated under the Directive 2014/53/EU [i.1]. The frequency usage conditions for the bands 2 483,5 MHz to 2 500 MHz are EU wide harmonised for the SRD category "active medical implant devices" according to Commission Implementing Decision 2013/752/EU [i.13] with the following usage restrictions: - "This set of usage conditions is only available to active implantable medical devices. Peripheral master units are for indoor use only." The present document contains the technical characteristics for LP-AMI and associated peripherals LP-AMI-P radio equipment which is also addressed by CEPT/ERC/REC 70-03 [i.3] annex 12 sub-band e) to that document. It does not necessarily include all the characteristics, which may be required by a user, nor does it necessarily represent the optimum performance achievable. The present document applies to LP-AMI and LP-AMI_P operating in the band 2 483,5 MHz to 2 500 MHz: - for telecommand and telemetry between LP-AMI and LP-AMI-P; - for telecommand and telemetry between LP-AMI to another LP-AMI; - with or without an integral antenna; and/or - with an antenna connection provided only for the purpose of connecting a dedicated antenna. The present document contains required characteristics considered necessary for the radio devices used in AMICS to meet in order to efficiently use the available spectrum for the purpose of transferring data that is used in diagnosing and delivering therapies to individuals with various illnesses. Of particular importance is the inclusion of spectrum monitoring and access requirements (listen before talk protocol) designed to significantly reduce any interference potential between AMICS operating in the band or between an AMICS and the primary users of the band. The present document is a specific product standard applicable to low power transmitters that are part of a system used in the AMICS operating in spectrum within the frequency band 2 483,5 MHz to 2 500 MHz. The present document contains requirements to demonstrate that Low Power Active Medical Implants (LP-AMI) ".shall be so constructed that it both effectively uses and supports the efficient use of radio spectrum in order to avoid harmful interference" (article 3.2 of the Directive 2014/53/EU) [i.1]. The present document does not necessarily include all the requirements which may be required by a user, nor does it necessarily represent the optimum performance achievable.

Obsah

ČSN EN 61360-6 Tato část IEC 61360 poskytuje pokyny pro definici pojmů, které se používají k popisu tříd a vlastností navržených pro aktualizaci obsahu společného datového slovníku IEC (IEC CDD). Tato část IEC 61360 zahrnuje následující témata: - základní přehled o základních konceptech IEC 61360; - formulování definic a jiných prvků textu; - přehled o postupu údržby IEC CDD; - kontrolní seznam pro poskytování vstupních dat pro obsah IEC CDD.

Obsah

ČSN EN ISO 10360-12 This part of ISO 10360 specifies the acceptance tests for verifying the performance of an articulated arm CMM by measuring calibrated test lengths as stated by the manufacturer. It also specifies the reverification tests that enable the user to periodically reverify the performance of the articulated arm CMM. It applies to articulated arm CMMs using tactile probes and optionally optical distance sensors (also referred to as laser line scanners or laser line probes). Details on tests for scanner accessories are given in Annex E. This part of ISO 10360 does not specify how often or when testing is performed, if at all, nor does it specify which party should bear the cost of testing. This part of ISO 10360 specifies - performance requirements that can be assigned by the manufacturer or the user of the articulated arm CMM, - the manner of execution of the acceptance and reverification tests to demonstrate the stated requirements, - rules for proving conformance, and - applications for which the acceptance and reverification tests can be used.