Normy

Obsah

ČSN EN ISO 17665 ČSN EN ISO 17665:2025 stanovuje požadavky na vývoj, validaci a průběžnou kontrolu procesu sterilizace zdravotnických prostředků vlhkým teplem. Obsahuje pokyny a návody pro splnění požadavků stanovených v normativních částech, které jsou určeny na podporu správné výrobní praxe v průmyslových a zdravotnických zařízeních. Toto první vydání normy zrušuje a nahrazuje předchozí vydání norem ISO 17665-1:2006, ISOTS 17665-2:2009 a ISO/TS 17665-3:2013, které byly rozsáhle technicky revidovány.

Obsah

ČSN EN ISO 25539-3 This document specifies the requirements for the evaluation of vena cava filter systems (filters and delivery systems) and the requirements with respect to nomenclature, design attributes and information supplied by the manufacturer. Guidance for the development of in vitro test methods is included in Annex D. This document is intended to be used in conjunction with ISO 14630, which specifies general requirements for the performance of non-active surgical implants. NOTE 1 - Due to the variations in the design of implants covered by this document, and in some cases due to the emergence of novel types of such implants, acceptable standardized in vitro tests and clinical results are not always available. As further scientific and clinical data become available, a revision of this document will be necessary. This document is applicable to vena cava filters intended to prevent symptomatic pulmonary embolism by capturing blood clots in the inferior vena cava (IVC). While this document can be useful with respect to filters implanted in other venous locations (e.g. superior vena cava, iliac veins), it does not specifically address the use of filters in other implantation sites. This document is also applicable to permanent filters together with their associated delivery systems, optional filters that can be retrieved and their associated retrieval systems, and convertible filters and their associated conversion systems. While this document can be useful with respect to the evaluation of repositioning filters after chronic implantation, it does not specifically address filter repositioning. This document is not applicable to - temporary filters (e.g. tethered) that need to be removed after a defined period of time, - issues associated with viable tissues and non-viable biological materials, and - procedures and devices (e.g. venous entry needle) used prior to the vena cava filter procedure. Although absorbable filters and filters with absorbable coatings are within the scope of this document, this document is not comprehensive with respect to the absorbable properties of these devices. NOTE 2 - Absorbable implants are covered in ISO/TS 17137. Although coated filters and coated filter systems are within the scope of this document, this document is not comprehensive with respect to coatings. NOTE 3 - Vascular device-drug combination products are covered in ISO 12417-1 and some coating properties are covered in ISO 25539-4.

Obsah

ČSN EN 15877-1 Tento dokument specifikuje označení železničních nákladních vozů nebo částí železničních nákladních vozů, které se týkají jejich technických, provozních a udržovacích požadavků. Specifikuje vlastnosti těchto označení, požadavky vztahující se na jejich použití, tvar a umístění na železničním vozidle a jejich význam. Pokud je to účelné, jsou některá označení doprovázena poznámkou (poznámkami). Navrhovaná kritéria, zkoušky a technický popis štítků výrobců cisternových vozů nebyly v tomto dokumentu brány v úvahu, protože jsou specifikovány v EN 12561-1:2011. Označení pro nebezpečné zboží nebyly do této normy zahrnuty, protože jsou plně popsány v RID [14] (rozměry, barevné provedení, umístění a tvar). Pokud není označení dostatečně popsáno v RID, je uvedeno v tomto dokumentu.

Obsah

ČSN EN 14750 This document establishes thermal comfort parameters for areas accessible to passengers and staff on railway vehicles. This document also specifies conditions, performance values and the comfort parameter validation methods. This document is applicable to urban (metro, tramway), suburban and/or regional vehicles equipped with cooling and/or heating/ventilation systems. This document does not apply to main line vehicles and driver's cabs which are considered in separate Standards.

Obsah

ČSN EN 16803-4 This document is mainly addressed to GNSS-specialized laboratories, in charge of creating reference test scenarios that will be replayed by other users such as generalist RF lab. It is a fundamental key-point to be able to deliver homogenous test scenarios. Indeed, in the context of GNSS receiver certification, the process itself is independent from the laboratory which designed and made the scenario. In other words, the conformity level of any GNSS-based positioning terminal (GBPT) is the same whatever the specific scenario used. Using a specific urban scenario from a GNSS-specialized laboratory A leads to the same conclusion as using another specific urban scenario from a GNSS-specialized laboratory B. This is really the aim of this document: giving requirements and guidelines to all GNSS-specialized laboratories in order to make inter-operable test scenarios. It will thus provide requirements and guidelines on the following topics: - what technical documentations are required to design test scenarios (Clause 4) through: - technical documentation for "R&R", - list of documents to produce for simulation scenario; - how to collect data in order to build test scenarios (Clause 5) through: - identification of the technical documentation, - requirements for human resources, - requirements for tests platform, - requirement for RTMeS, - requirement for GNSS signals digitization, - requirements for GNSS constellations simulator, - requirements for benchmark GNSS receiver, - requirement for GBPT embedded, - requirements for other sensors; - how to validate data - after a data collection- in order to be sure of it (Clause 6) through: - validation of the field test, - validation of data for reference trajectory, - validation of digitized GNSS signals, - validation of SENSORS inertial measurements, - validation of corrections data (NRTK, PPP.), - characterization of the scenario.

Obsah

ČSN EN 16605 This document specifies the functional and performance requirements and associated tests for Galileo timing receivers. The approach for this document is that of a performance based, meaning that no specific algorithm implementation is required. Instead, performance requirements are specified together with a corresponding test suite for verification. This document is applicable to the Galileo chipset. This document does not apply to other sensors and/or additional processing that a higher synchronization Unit can implement on top of the Galileo chipset. This document is applicable to the following aspects related to Galileo timing receivers: - GNSS constellations and frequencies processed: Galileo Dual-Frequency. Other modes are optional, as explained below; - time scales, including Galileo System Time and Coordinated Universal Time; - Services Levels, this document covers the 2 levels of Service for GST and for UTC to be provided by Galileo Time Service in the first place. The document also anticipates a third Service Level to be provided in the future, for which an update of the document will be needed; - user dynamics: fixed users, defined as static users with precise knowledge of the antenna position, is the baseline mode; - processing of Timing Service Message disseminated by the Galileo System; - local timing integrity barriers: As a minimum, Time Receiver Autonomous Integrity Monitoring processing (T-RAIM); - robustness to interferences; - Galileo Open Service Navigation Message Authentication processing; - robustness to multipath. This document does not apply to the processing of GPS constellation but this does not preclude Manufacturers to implement GPS processing within the Galileo timing receivers, even if not addressed in this document. The use of other GNSS constellations is not forbidden by this document but the requirements and tests are defined considering Galileo-only, including those related to the integrity of the timing solution. This document does not apply to single-frequency modes. This does not preclude manufacturers to implement single-frequency modes within the Galileo timing receivers, even if not addressed in this document, as a back-up of the nominal Dual-Frequency mode, and reversion mechanisms. It is important to remark that the integrity of the timing solution is only specified for Galileo Dual-Frequency mode. The Galileo timing receivers is only applicable to users operating in static conditions. This document does not apply to moving users. On top of the functional requirements, performance requirements are specified in this document in terms of different key performance indicators such as: - accuracy, availability and integrity requirements; - local barriers, T-RAIM performances. This document also provides the verification matrix and specifies the test suite to verify the most fundamental requirements of the Galileo timing receivers. Finally, this document specifies a subclause dedicated to guidelines for the installation and maintenance of the Galileo timing receivers. This is a comprehensive subclause, including provisions for the antenna, cabling and receiver installation, as well as the calibration of time delays.

Obsah

ČSN EN 17997 This document specifies the methodology to define the train related braking model and required emergency and service brake on-board parameters to enable speed and distance monitoring for trains equipped and operated on railway lines using ETCS Baseline 3. This document is only applicable for ETCS Gamma braking model trains (i.e. the train is said to be a "gamma" train). This document does not specify the way these parameters are transferred to and can be used by the ETCS on-board system (e.g. during start of mission - SoM). The ETCS "conversion models" are not covered by this document and are described in EN 16834:2019, Annex F. The ETCS "conversion models" are intended for use with trains where the braking performance is expressed using braked weight percentages ("lambda" train). Any trackside related input parameters, including national values, are not covered in this document. Information can be found in the SUBSET-026 (see [11]).

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ČSN EN 14211 This document specifies a continuous measurement method for the determination of the concentrations of nitrogen dioxide and nitrogen monoxide present in ambient air based on the chemiluminescence measuring principle. This document describes the performance characteristics and sets the relevant minimum criteria required to select an appropriate chemiluminescence analyser by means of type testing. It also includes the evaluation of the suitability of an analyser for use in a specific fixed site so as to meet the data quality requirements (see Annex I of Directive 2008/50/EC [1] for additional information) and requirements during sampling, calibration and quality assurance for use. The method is applicable to the determination of the concentration of nitrogen dioxide present in ambient air up to 500 µg/m3. This concentration range represents the certification range for nitrogen dioxide for type testing. The method is applicable to the determination of the concentration of nitrogen monoxide present in ambient air up to 1 200 µg/m3. This concentration range represents the certification range for nitrogen monoxide for the type testing. The method covers the determination of ambient air concentrations of nitrogen dioxide and nitrogen monoxide in zones classified as rural areas, urban-background areas, traffic-orientated locations and locations influenced by industrial sources. The results are expressed in µg/m3 (at 20 °C and 101,3 kPa). This document contains information for different groups of users. Clause 5 to Clause 7 and Annex B and Annex C contain general information about the principles of NOx measurement by chemiluminescence analyser and sampling equipment. Clause 8, Annex E is specifically directed towards test houses and laboratories that perform type testing of NOx analysers. These sections contain information about: - type testing conditions, test procedures and test requirements; - analyser performance requirements; - evaluation of the type testing results; - evaluation of the associated uncertainty of the measurement performed by the NOx analyser based on the type testing results. Clause 9 to Clause 11 and Annex F and Annex G are directed towards monitoring networks performing the practical measurements of NOx in ambient air. These sections contain information about: - initial installation of the analyser in the monitoring network and acceptance testing; - ongoing quality assurance/quality control; - calculation and reporting of measurement results; - evaluation of the associated uncertainty of the measurements under practical monitoring conditions. This document represents an evolution of earlier editions (EN 14211:2005 and EN 14211:2012).

Obsah

ČSN EN 14625 This document specifies a continuous measurement method for the determination of the concentrations of ozone present in ambient air based on the ultraviolet photometric measuring principle. This document describes the performance characteristics and sets the relevant minimum criteria required to select an appropriate ultraviolet photometric analyser by means of type testing. It also includes the evaluation of the suitability of an analyser for use in a specific fixed site in order to meet the data quality requirements (see Annex I of Directive 2008/50/EC [1] for additional information) and requirements during sampling, calibration and quality assurance for use. The method is applicable to the determination of the concentration of ozone present in ambient air up to 500 µg/m3. This concentration range represents the certification range for ozone for type testing. The method covers the determination of ambient air concentrations of ozone in zones classified as rural areas, urban and urban-background areas. The results are expressed in µg/m3 (at 20 °C and 101,3 kPa). This document contains information for different groups of users. Clause 5 to Clause 7 and Annex B and Annex C contain general information about the principles of ozone measurement by ultraviolet photometric analyser and sampling equipment. Clause 8 and Annex E are specifically directed towards test houses and laboratories that perform type testing of ozone analysers. These sections contain information about: - type testing conditions, test procedures and test requirements; - analyser performance requirements; - evaluation of the type testing results; - evaluation of the associated uncertainty of the measurement performed by the ozone analyser based on the type testing results. Clause 9 to Clause 11 and Annex F and Annex G are directed towards monitoring networks performing the practical measurements of ozone in ambient air. These sections contain information about: - initial installation of the analyser in the monitoring network and acceptance testing; - ongoing quality assurance/quality control; - calculation and reporting of measurement results; - evaluation of the uncertainty of measurement results under practical monitoring conditions. This document represents an evolution of earlier editions (EN 14625:2005 and EN 14625:2012).

Obsah

ČSN EN 14212 This document specifies a continuous measurement method for the determination of the concentration of sulfur dioxide present in ambient air based on the ultraviolet fluorescence measuring principle. This document describes the performance characteristics and sets the relevant minimum criteria required to select an appropriate ultraviolet fluorescence analyser by means of type testing. It also includes the evaluation of the suitability of an analyser for use in a specific fixed site so as to meet the data quality requirements (see Annex I of Directive 2008/50/EC [1] for additional information) and requirements during sampling, calibration and quality assurance for use. The method is applicable to the determination of the mass concentration of sulfur dioxide present in ambient air up to 1000 µg/m3. This concentration range represents the certification range for sulfur dioxide for type testing. The method covers the determination of ambient air concentrations of sulfur dioxide in zones classified as rural areas, urban-background areas, traffic-oriented locations and locations influenced by industrial sources. The results are expressed in µg/m3 (at 20 °C and 101,3 kPa). This document contains information for different groups of users. Clause 5 to Clause 7 and Annex C and Annex D contain general information about the principles of sulfur dioxide measurement by ultraviolet fluorescence analyser and sampling equipment. Clause 8 and Annex E are specifically directed towards test houses and laboratories that perform type testing of sulfur dioxide analysers. These sections contain information about: - type testing conditions, test procedures and test requirements; - analyser performance requirements; - evaluation of the type testing results; - evaluation of the associated uncertainty of the measurement performed by the sulfur dioxide analyser based on the type testing results. Clause 9 to Clause 11 and Annex F, Annex G and Annex H are directed towards monitoring networks performing the practical measurements of sulfur dioxide in ambient air. These sections contain information about: - initial installation of the analyser in the monitoring network and acceptance testing; - ongoing quality assurance/quality control; - calculation and reporting of measurement results; - evaluation of the uncertainty of the measurement results under practical monitoring conditions. This document represents an evolution of earlier editions (EN 14212:2005 and EN 14212:2012).

Obsah

ČSN EN IEC 62127-2 ed. 2 This part of IEC 62127 specifies absolute hydrophone calibration methods and relative (comparative) hydrophone calibration methods. Recommendations and references to accepted literature are made for the various relative and absolute calibration methods in the frequency range covered by this document.

Obsah

ČSN ETSI EN 301 908-14 V17.1.1 The present document specifies technical characteristics and methods of measurements for the types of equipment: Base Station for Evolved Universal Terrestrial Radio Access (E-UTRA). Base Station for Evolved Universal Terrestrial Radio Access (E-UTRA) with NB-IoT. Base Station for NB-IoT standalone. NOTE - UTRA TDD is not included in Release 17 of ETSI EN 301 908. This radio equipment type is capable of operating in all or any part of the operating bands given in table 1-1. Unless stated otherwise, requirements specified for the TDD duplex mode apply for downlink and uplink operations in Frame Structure Type 2. NB-IoT is designed to operate in the E-UTRA operating bands 1, 3, 8, 20, 28, 31, 41, 42, 43, 65, 72, 87, 88 which are defined in table 1-1. The present document covers the requirements for E-UTRA Base Stations for 3GPP Release 8, 9, 10, 11, 12, 13, 14, 15, 16 and 17. Additionally, it includes the requirements for E-UTRA Base Station operating bands from 3GPP Release 18. The RF requirements in the present document do not apply for multi-band operation supporting bands for both FDD and TDD. NOTE - 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.