Normy

Obsah

ČSN EN ISO 3826-1 This document specifies requirements, including performance requirements, for plastics collapsible, non-vented, sterile containers (known as plastics containers) complete with collecting tube outlet port(s), integral needle, and with optional transfer tube(s), for the collection, storage, processing, transport, separation, and administration of blood and blood components. The plastics containers can contain anticoagulant and/or preservative solutions, depending on the application envisaged. This document is also applicable to multiple units of plastics containers, e.g. to double, triple, quadruple, or multiple units. Unless otherwise specified, all tests specified in this document apply to the plastics container as prepared ready for use. This document is not applicable to plastics containers with an integrated filter.

Obsah

ČSN EN ISO 20186-3 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 EN ISO 28721-1 This document specifies the quality requirements for apparatus, components, appliances and accessories of glass-lined steel (including semi-crystallized enamel coatings) and glass-lined steel castings used for process plants. It specifies the quality requirements and the tests to be carried out by the manufacturer as well as the actions to be taken to repair defects. It is also applicable to glass-lined pumps, pump components and fittings. It does not apply to glass-lined flanged steel pipes or glass-lined flanged steel fittings. NOTE 1 - Provisions for glass-lined flanged steel pipes and glass-lined flanged steel fittings are given in ISO 28721-4. The test methods specified cover checking the enamel, the dimensional accuracy and the performance of apparatus and components. This document is applicable to new apparatus and components as well as used items that have been re-enamelled. It does not contain requirements regarding the chemical or physical properties of vitreous and porcelain enamels. NOTE 2 - Examples of test reports are given in Annex A.

Obsah

ČSN EN ISO 22301 Tento dokument specifikuje požadavky na implementaci, udržování a zlepšování systému managementu k ochraně před narušením, snižování pravděpodobnosti jeho výskytu, přípravu, reagování a obnovu, pokud se vyskytne. Požadavky uvedené v této mezinárodní normě jsou obecné povahy a mají být použitelné pro všechny organizace nebo jejich části, bez ohledu na druh, velikost a typ organizace. Rozsah použití těchto požadavků závisí na prostředí, ve kterém se organizace pohybuje, a na její složitosti.

Obsah

ČSN EN IEC 60317-0-8 ed. 2 Tato norma stanovuje obecné požadavky na měděné vodiče pro vinutí pravoúhlého průřezu, holé, nebo stupně 1 nebo stupně 2, nebo lakované, ovinuté vláknem polyester-sklo, stavené, neimpregnované, nebo impregnované pryskyřicí nebo lakem.

Obsah

ČSN EN 50411-3-3 Norma obsahuje počáteční a na začátku života rozměrové, optické a mechanické vlastnosti a požadavky funkčnosti ve vnějším prostředí pro chránítka svařovaných jednovidových spojů, aby mohla být zařazena jako výrobek odpovídající požadavkům pro kategorie definované evropskou normou. Přestože je v tomto dokumentu výrobek kvalifikován pro jednovidová vlákna EN IEC 60793-2-50 typu B-652.D je vhodný i pro ochranu svařovaných spojů mnohovidových vláken se skleněným pláštěm o průměru 125 µm a jiných jednovidových vláken se skleněným pláštěm o průměru 125 µm. Norma obsahuje normativní přílohu A, B a C a informativní přílohu D. Příloha A popisuje typy vláken pro zkušební vzorek, příloha B popisuje požadavky na velikost vzorku a zajištění výrobku, příloha C uvádí popis a instalaci zkušebního vzorku a příloha D popisuje teplem smrštitelná chránítka svařovaných spojů ve formě silikonového pásku.

Obsah

ČSN EN IEC 62885-9 This part of IEC 62885 lists the characteristic performance parameters for walk-behind and ride-on floor scrubbers and sweepers and other floor cleaning machines in accordance with IEC 60335-2-72:2016. The intent is to serve the manufacturers in describing parameters for their manuals and their literature. This may include all or some of the parameters listed in this definition document.

Obsah

ČSN EN IEC 62985 This document applies to CT SCANNERS that are able to display and report CTDIVOL in accordance with IEC 60601-2-44, and RADIATION dose index monitoring software (RDIMS) for the purpose of calculating, displaying and recording the SIZE SPECIFIC DOSE ESTIMATE (SSDE) and its associated components. Specifically, this document provides standardized methods and requirements for calculating, displaying, or recording of SSDE, SSDE(z), WATER EQUIVALENT DIAMETER (DW), and DW(z), where z represents a specific longitudinal position of the scanned object. This document provides a method of determining a reference WATER EQUIVALENT DIAMETER, DW,REF(z), using CT scans of two cylindrical water PHANTOMS and one or more anthropomorphic PHANTOM(S), which conform to the specifications defined in this document. The method of calculating the WATER EQUIVALENT DIAMETER that is implemented by the MANUFACTURER, DW,IMP(z), is tested and validated against DW,REF(z) using the TEST OBJECTS and methods defined within this document. This document also describes the methods for calculating SSDE and DW, which represent the average values of SSDE(z) and DW(z) over the RECONSTRUCTION LENGTH.

Obsah

ČSN EN 12716 (73 1072) Tento dokument stanovuje obecné principy provádění prací tryskové injektáže. POZNÁMKA - Postupy tryskové injektáže se liší od postupů injektáže popsané v EN 12715.

Obsah

ČSN ETSI EN 301 908-1 V13.1.1 The present document applies to user equipment, repeaters and base stations for IMT, falling within the scope of one of the other parts of ETSI EN 301 908 [i.8], except for IMT-2000 FDMA/TDMA (DECT). The present document also covers the corresponding ancillary equipment. NOTE 1: ETSI EN 301 908-10 [i.7] contains in particular requirements for radiated spurious emissions and control and monitoring functions applicable to IMT-2000 FDMA/TDMA (DECT) equipment. The present document includes technical requirements which are common to equipment falling within the scope of several of the other parts. It should be used in conjunction of at least another part of ETSI EN 301 908 [i.8]. NOTE 2: The other parts of ETSI EN 301 908 [i.8], which are listed in the foreword of the present document, specify technical requirements in respect of a particular type of IMT equipment. NOTE 3: Recommendations ITU R M.1457 12 [i.4] and M.2012-1 [i.5] define the characteristics of the members of the IMT-2000 family and IMT-Advanced respectively by means of references to technical specifications developed by Standards Development organizations. The present document applies to equipment designed to meet any version of the terrestrial specifications referenced in Recommendations ITU R M.1457 12 [i.4] and M.2012-1 [i.5]. 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. NOTE 4: The relationship between the present document and essential requirements of article 3.2 of Directive 2014/53/EU [i.1] is given in annex A.

Obsah

ČSN EN ISO 12944-5 Norma popisuje typy nátěrů a nátěrových systémů, které se běžně používají k protikorozní ochraně ocelových konstrukcí. Uvádí rovněž instrukce pro výběr nátěrových systémů vhodných pro různá prostředí s výjimkou stupně korozní agresivity CX a stupně Im4 podle ČSN EN ISO 12944-2, pro různé stupně přípravy povrchu a předpokládanou životnost. V přílohách uvádí minimální požadavky na protikorozní ochranné systémy (přípravu povrchu, minimální počet vrstev a jmenovitou tloušťku suchého filmu), nátěrové systémy na uhlíkovou ocel, na ponorem žárově zinkovanou ocel, na žárově stříkané kovové povlaky. Dále se zabývá svařitelnými základními nátěrovými hmotami.

Obsah

ČSN EN ISO 11117 This document specifies the requirements for valve protection caps and valve guards used on cylinders for liquefied, dissolved or compressed gases. Valve protection caps and valve guards are some of the options available to protect cylinder valves, including valves with integral pressure regulators (VIPRs) during transport. This document is applicable to valve protection caps and valve guards which inherently provide the primary protection of a cylinder valve. It can also be used to test other equipment (e.g., handling devices) attached to cylinder packages, even in cases where the cylinder valve is inherently able to withstand damage without release of the content. This document excludes protection devices for cylinders with a water capacity of 5 l or less and cylinders whereby the protection device is fixed by means of lugs welded or brazed to the cylinder, or is welded or brazed directly to the cylinder. This document does not cover valve protection for breathing apparatus cylinders. NOTE - Small cylinders (e.g., medical cylinders) are commonly transported in an outer-packaging (e.g., pallet) to meet transport regulations. This document does not specify requirements that could be necessary to enable the valve protection device to be used for lifting the cylinder.