Normy

Obsah

ČSN EN ISO 20186-2 This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for genomic DNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for stabilizing blood cell free circulating DNA, which are not described in this document. NOTE: Circulating cell free DNA in blood is covered in ISO 20186-3. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of genomic DNA therefrom. DNA in pathogens present in blood is not covered by this document.

Obsah

ČSN EN ISO 20186-1 This document gives guidelines on the handling, storage, processing and documentation of venous whole blood specimens intended for cellular RNA examination during the pre-examination phase before a molecular examination is performed. This document covers specimens collected in venous whole blood collection tubes. This document is applicable to any molecular in vitro diagnostic examination performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions and commercial organizations performing biomedical research, and regulatory authorities. Different dedicated measures are taken for stabilizing blood cell free circulating RNA and RNA in exosomes circulating in blood. These are not described in this document. Different dedicated measures are taken for collecting, stabilizing, transporting and storing capillary blood as well as for collecting and storing blood by paper based technologies or other technologies generating dried blood. These are not described in this document. This document does not cover the isolation of specific blood cells and subsequent isolation of cellular RNA therefrom. RNA in pathogens present in blood is not covered by this document.

Obsah

ČSN ETSI EN 301 489-35 V2.2.1 The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated with Low Power Active Medical Implants (LP-AMIs) and associated Peripheral devices (LP-AMI-P) in respect of ElectroMagnetic Compatibility (EMC). The present document covers the EMC requirements for the radio functions of LP-AMI and associated Peripheral devices (LP-AMI-P). Technical specifications related to the antenna port and emissions from the enclosure port of the radio system of LP AMI and associated Peripheral devices (LP-AMI-P) are not included in the present document. Such technical specifications are found in the relevant product standards for the effective use of the radio spectrum. The present document specifies the applicable test conditions, performance assessment, and performance criteria for of LP-AMI and associated Peripheral devices (LP-AMI-P). Definitions of types of LP-AMIs and P-AMI-Ps covered by present document are given in annex B. In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present document and ETSI EN 301 489 1 [1], the provisions of the present document take precedence. The environmental classification and the emission and immunity requirements used in the present document are as stated in the ETSI EN 301 489 1 [1], except for any special conditions included in the present document. The present document, together with ETSI EN 301 489-1 [1], contains requirements to demonstrate an adequate level of electromagnetic compatibility as set out in Directive 2014/53/EU [i.1].

Obsah

ČSN ETSI EN 301 489-50 V2.2.1 The present document specifies technical characteristics and methods of measurements for equipment the following equipment types: 1) digital cellular base station equipment; 2) repeaters; 3) associated ancillary equipment. Including individually and combinations of: - UTRA, WCDMA (IMT-2000 Direct Spread, W-CDMA, UMTS); - E-UTRA, LTE (IMT-2000 and IMT advanced); - GSM (IMT-2000 SC, Technology GSM/EDGE); - MSR (IMT-2000 and IMT advanced, combination of technologies above); - OFDMA WMAN (IMT-2000 OFDMA, OFDMA WMAN); - CDMA (CDMA2000 - IMT MC, CDMA2000 1X). Technical specifications related to the antenna port and emissions from the enclosure port of radio equipment (base station (BS), and repeaters) are not included in the present document. Such technical specifications are found in the relevant product standards for the effective use of the radio spectrum. Examples of base station equipment covered by the present document are given in annex B. In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present document and ETSI EN 301 489 1 [1], the provisions of the present document take precedence. The present document covers the essential requirements of article 3.1(b) of Directive 2014/53/EU under the conditions identified in annex A. Technical specifications related to the antenna port of radio equipment and radiated emissions from the enclosure port of radio equipment and combinations of radio and associated ancillary equipment are given in the harmonised product standards ETSI EN 301 908-1 [28] or ETSI EN 301 502 [8] for the effective and efficient use of the radio spectrum.

Obsah

ČSN ETSI EN 301 489-53 V1.1.1 Tento dokument stanovuje technické vlastnosti a metody měření pro vysílače, budiče, opakovače, aktivní deflektory, kanálové opakovače a jakákoliv související přidružená zařízení služby zemského rozhlasového a digitálního TV vysílání. Tento dokument pokrývá základní požadavky článku 3.1(b) Směrnice 2014/53/EU za podmínek uvedených v příloze A. Technické specifikace vztahující se k emisím z anténního vstupu/výstupu a vyzařování krytem nejsou v tomto dokumentu obsaženy. Tyto technické specifikace lze nalézt v příslušných normách výrobků ETSI pro efektivní využívání rádiového spektra. V případě rozdílů (například ohledně zvláštních podmínek, definic, zkratek) mezi tímto dokumentem a EN 301 489-1 mají přednost ustanovení tohoto dokumentu. Tento dokument nemusí pokrývat ty případy, kdy se trvale vyskytuje potenciální zdroj rušení, který vytváří jednotlivě se opakující přechodné jevy nebo trvalé jevy, například radarové stanoviště v těsné blízkosti. V takovém případě může být nutná zvláštní ochrana použitá buď na zdroj rušení, nebo na část vystavenou rušení, nebo na obojí.

Obsah

ČSN ETSI EN 301 489-29 V2.2.1 The present document together with ETSI EN 301 489-1 [1], covers the assessment of all radio transceivers associated with Ultra Low Power Active Medical Implants (ULP-AMIs), Ultra Low Power Active Medical Devices (ULP-AMDs), Ultra Low Power Body Worn Devices (ULP-BWDs) and associated Ultra Low Power Active Medical Implant Peripherals (ULP-AMI-Ps), Ultra Low Power Active Medical Device Peripherals (ULP-AMD-Ps) in respect of ElectroMagnetic Compatibility (EMC). The radio link may be part of life supporting or non-life supporting equipment and can be classified independently of the classification of the medical portion of the device. The present document covers the EMC requirements for the radio functions of ultra low power implanted, body worn and associated ultra low power peripheral devices. Technical specifications related to the antenna port and emissions from the enclosure port of these radio system devices are not included in the present document. Such technical specifications are found in the relevant product standards for the effective use of the radio spectrum. The present document applies to ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P devices with RF power levels ranging up to 25 µW ERP and intended for operation in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz in accordance with the provisions of annex 12, band b) and band c), to CEPT/ERC/REC 70 03 [i.3]. Definitions of such ULP-AMI, ULP-AMD, ULP-BWD, ULP-AMD-P and ULP-AMI-P radio devices are found in the following functional radio standard: - ETSI EN 302 537 [2]: "Ultra Low Power Medical Data Service (MEDS) Systems operating in the frequency range 401 MHz to 402 MHz and 405 MHz to 406 MHz; Harmonised Standard covering the essential requirements of article 3.2 of the Directive 2014/53/EU [i.1]". In case of differences (for instance concerning special conditions, definitions, abbreviations) between the present document and ETSI EN 301 489 1 [1], the provisions of the present document take precedence. The environmental classification and the emission and immunity requirements used in the present document are as stated in the ETSI EN 301 489 1 [1], except for any special conditions included in the present document. The present document, together with ETSI EN 301 489-1 [1], are aimed to cover requirements to demonstrate an adequate level of electromagnetic compatibility.

Obsah

ČSN EN ISO 24598 - electrodes and electrode/flux combinations (all-weld metal deposits) for submerged arc welding of creep resisting and low-alloy elevated-temperature application steels. One electrode can be tested and classified with different fluxes. The solid wire electrode is also classified separately based on its chemical composition. - This document is a combined specification providing a classification system based on either: - the chemical composition of the solid wire electrode and all-weld metal deposit; or - the tensile strength of the all-weld metal deposit and the chemical composition of the solid wire electrode and all-weld metal deposit obtained with the electrode/flux combination. a) Clauses, subclauses and tables which carry the suffix letter "A" are applicable only to solid wire electrodes, tubular cored electrodes and all-weld metal deposits classified in accordance with the system based upon chemical composition. b) Clauses, subclauses and tables which carry the suffix letter "B" are applicable only to solid wire electrodes, tubular cored electrodes and all-weld metal deposits classified in accordance with the system based upon the tensile strength of all-weld metal deposits and the chemical composition of solid wire electrodes and all-weld metal deposits. c) Clauses, subclauses and tables which do not have either the suffix letter "A" or the suffix letter "B" are applicable to all solid wire electrodes, tubular cored electrodes and electrode/flux combinations classified under this document.

Obsah

ČSN EN 3275 This European standard specifies the required characteristics, inspection and test methods, quality assurance and procurement requirements for metric series 8°30' dynamic beam seal pipe couplings, for temperature ranges type II and III according to ISO 6771 and nominal pressure up to 28 000 kPa.

Obsah

ČSN IEC 60092-101 Soubor IEC 60092 zahrnuje mezinárodní normy pro elektrické instalace v námořních lodích, zahrnující osvědčené postupy a koordinuje, pokud je to možné, existující pravidla. Tento soubor norem tvoří kodex praktické interpretace a prohlubuje požadavky Mezinárodní úmluvy o bezpečnosti lidského života na moři", jako návodu pro budoucí právní úpravy, které smí být připravovány a uvedeny do praxe majiteli plavidel, loděnicemi a příslušnými organizacemi. Tato část souboru IEC 60092 platí pro elektrická zařízení určená pro používání na lodích.

Obsah

ČSN EN 50341-2-2 This NNA has to be read in conjunction with Part 1 (EN 50341-1). All clause numbers used in this NNA correspond to those of Part 1. Specific subclauses, which are prefixed "BE", are to be read as amendments to the relevant text in Part 1. Any necessary clarification regarding the application of this NNA in conjunction with Part 1 shall be referred to the Belgian NC who will, in co-operation with CLC/TC11, clarify the requirements. Where no reference is made in this NNA to a specific subclause, then Part 1 applies. In case of "boxed values" defined in Part 1, amended values (if any), which are defined in this NNA shall be taken into account in Belgium. However, any boxed value, whether in Part 1 or this NNA, shall not be amended in the direction of greater risk in a Project Specification. The national Belgian standards/regulations related to overhead electrical lines exceeding 1 kV (AC) are listed in subclauses 2.1/BE.1 and BE.2. Only significant extracts and summaries of the Belgian national regulations are presented in the A-deviations. They must be read in conjunction with the Belgian national regulations identified in 2.1/BE.1 which is in any case the relevant document.

Obsah

ČSN EN IEC 61000-6-4 ed. 3 Tato část souboru norem stanovující požadavky EMC pro emise platí pro elektrické a elektronické přístroje určené pro použití v místech s průmyslovým prostředím. Tento dokument se nevztahuje na přístroje spadající do rozsahu platnosti IEC 61000-6-3. Prostředí, spadající do rozsahu tohoto dokumentu, se vztahují jak na vnitřní, tak venkovní prostory (areály). Požadavky na emise jsou pokryty v kmitočtovém rozsahu 0 Hz až 400 GHz a tyto požadavky byly stanoveny tak, aby poskytly dostatečnou úroveň ochrany rádiového příjmu ve stanoveném elektromagnetickém prostředí. Na kmitočtech, kde nejsou stanoveny požadavky, není třeba provádět měření. Tyto požadavky se považují za základní pro to, aby se zajistila dostatečná ochrana rádiových služeb. Pro účely zkoušení nebyly zahrnuty veškeré rušivé jevy, ale jen ty které se považují za odpovídající pro přístroje určené k provozu v prostředí popsaném v tomto dokumentu. Požadavky na zkoušení jsou stanoveny pro každý uvažovaný vstup/výstup (port). Tuto kmenovou normu EMC pro emise je třeba použít, jestliže neexistují normy EMC pro emise konkrétně zaměřené na výrobek nebo skupinu výrobků.

Obsah

ČSN EN IEC 62909-2 This part of IEC 62909 specifies GCPC interface requirements for particular distributed energy resources, namely electric vehicle (EV), battery, and photovoltaic (PV) systems. These requirements are in addition to the general requirements given in IEC 62909-1.