Normy

Obsah

ČSN ETSI EN 301 908-18 V15.1.1 The present document specifies technical characteristics and methods of measurements for the following equipment types: Multi-Standard Radio capable Base stations (NR, E-UTRA, UTRA, GSM/EDGE, NB-IoT). Operation of NR in combination with UTRA or GSM/EDGE is not supported. These radio equipment types are capable of operating in all or any part of the frequency bands given in table 1-1. NOTE 1 - For BS capable of multi-band operation, the supported operating bands may belong to different Band Categories. The present document covers conducted requirements for multi-RAT capable NR, E-UTRA, UTRA and GSM/EDGE MSR Base Stations for 3GPP™ Release 9, 10, 11, 12, 13, 14 and 15. This includes the requirements for MSR operating bands from 3GPP Release 16. NOTE 2 - 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 ETSI EN 302 326-2 V2.1.1 The present document specifies technical characteristics and methods of measurements applicable to radio equipment used in MultiPoint (MP) Digital Fixed Radio Systems (DFRS) (see note 2) designed for use in the following sub-ranges (see note 3): - 30 MHz to 1 GHz. - 1 GHz to 3 GHz. - 3 GHz to 11 GHz. - 24,25 GHz to 29,5 GHz. - 31,0 GHz to 33,4 GHz. - 40,5 GHz to 43,5 GHz. NOTE 1 - 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. The present document is applicable to multipoint radio system equipment using any arbitrary access method. It applies to all equipment composing the MP systems, i.e. to Central Station (CS), Terminal Station (TS) and Repeater Station (RS). Time Division Duplex (TDD) or Frequency Division Duplex (FDD or H-FDD) can be used on an equivalent basis. Systems implementing an actual FH-CDMA access method with hopping period exceeding 400 ms are not considered within the scope of the present document. NOTE 2 - Applications intended for offering in the bands 3,4 GHz to 3,8 GHz the option of Nomadic Wireless Access (NWA), according to the NWA definition in Recommendation ITU R F.1399 [i.14], are also considered in the scope of the present document. NOTE 3 - For more information on the applicable frequency bands, refer to Annex F.

Obsah

ČSN EN IEC 60384-1 ed. 4 Tato mezinárodní norma IEC 60384-1 představuje kmenovou specifikaci pro neproměnné kondenzátory po-užívaných v elektronických zařízeních. Zahrnuje všeobecné požadavky a podmínky pro provádění elektrických, mechanických, klimatických a environmentálních zkoušek a měření a zkoušek vztahujících se k montáži a bezpečnosti součástek. Důležitou změnou proti předchozímu vydání je kompletní přepracování normy tak, aby odpovídala směrnicím ISO ISO/ IEC, část 2; rovněž byla zavedena nová technická kategorizace zkušebních metod. Zkušební metody byly reorganizovány podle těchto nových kategorií; tabulky, obrázky a odkazy byly odpovídajícím způsobem revidovány. Do normy byla navíc vložená příloha X, kde jsou uvedeny všechny změny v struktuře normy proti předchozímu vydání.

Obsah

ČSN EN ISO 80601-2-90 This document applies to the basic safety and essential performance of respiratory high-flow therapy equipment, as defined in 201.3.220, hereafter also referred to as ME equipment or ME system, in combination with its accessories: - intended for use with patients who can breathe spontaneously; and - intended for patients who would benefit from improved alveolar gas exchange; and who would benefit from receiving high-flow humidified respiratory gases, which can include a patient whose upper airway is bypassed. EXAMPLE 1 Patients with Type 1 Respiratory Failure who exhibit a reduction in arterial blood oxygenation. EXAMPLE 2 Patients who would benefit from reduced work of breathing, as needed in Type 2 Respiratory Failure, where arterial carbon dioxide is high. EXAMPLE 3 Patients requiring humidification to improve mucociliary clearance. Respiratory high-flow therapy equipment can be intended for use in the home healthcare environment or intended for use in professional healthcare facilities. NOTE 1 - In the home healthcare environment, the supply mains is often not reliable. Respiratory high-flow therapy equipment can be: - fully integrated ME equipment; or - a combination of separate items forming a ME system. This standard also applies to other types of respiratory equipment when that equipment includes a respiratory high-flow therapy mode. NOTE 2 - This standard and ISO 80601-2-12[14] are applicable to a critical care ventilator with a high-flow therapy mode. Respiratory high-flow therapy equipment can be transit-operable. This document is also applicable to those accessories intended by their manufacturer to be connected to the respiratory high-flow therapy equipment, where the characteristics of those accessories can affect the basic safety or essential performance of the respiratory high-flow therapy equipment. EXAMPLE 4 Breathing sets, connectors, humidifier, breathing system filter, external electrical power source, distributed alarm system, high-flow nasal cannula, tracheal tube, tracheostomy tube, face mask and supra-laryngeal airway. If a clause or subclause is specifically intended to be applicable to ME equipment only, or to ME systems only, the title and content of that clause or subclause will say so. If that is not the case, the clause or subclause applies both to ME equipment and to ME systems, as relevant. Hazards inherent in the intended physiological function of ME equipment or ME systems within the scope of this document are not covered by specific requirements in this document except in the general standard, 7.2.13 and 8.4.1. NOTE 3 - Additional information can be found in the general standard, 4.2. This document does not specify the requirements for: - ventilators or accessories for ventilator-dependent patients intended for critical care applications, which are given in ISO 80601-2-12[14]; - ventilators or accessories intended for anaesthetic applications, which are given in ISO 80601-2-13[15]; - ventilators or accessories intended for the emergency medical services environment, which are given in ISO 80601-2-84[20]; - ventilators or accessories intended for ventilator-dependent patients in the home healthcare environment, which are given in ISO 80601-2-72[17]; - ventilatory support equipment or accessories intended for patients with ventilatory impairment, which are given in ISO 80601-2-79[18]; - ventilatory support equipment or accessories intended for patients with ventilatory insufficiency, which are given in ISO 80601-2-80[19]; - sleep apnoea therapy ME equipment, which are given in ISO 80601-2-70[16]; - continuous positive airway pressure (CPAP) ME equipment; - high-frequency jet ventilators (HFJVs)[31], which are given in ISO 80601-2-87[21]; - gas mixers for medical use, which are given in ISO 11195[9]; - flowmeters, which are given in ISO 15002[11]; - high-frequency oscillatory ventilators (HFOVs), which are given in ISO 80601-2-87[21]; and - cuirass or "iron-lung" ventilation equipment. This document is a particular standard in the IEC 60601 series, the IEC 80601 series and the ISO 80601 series.

Obsah

ČSN EN 13941-2+A1 (38 3370) This document specifies requirements for design, calculation and installation of factory made thermal insulated bonded single and twin pipe systems for buried hot water networks for continuous operation with treated water at various temperatures up to 120 °C and occasionally peak temperatures up to 140 °C for maximum 300 h/a, and maximum internal pressure 2,5 MPa. Flexible pipe systems according to the EN 15632 series are not under the scope of this standard. The standard EN 13941, Design and installation of thermal insulated bonded single and twin pipe systems for directly buried hot water networks consists of two parts: a) EN 13941 1: Design; b) EN 13941 2: Installation. The requirements in this part, EN 13941 2, form a unity with those of EN 13941 1. The principles of the standard may be applied to thermal insulated pipe systems with pressures higher than 2,5 MPa, provided that special attention is paid to the effects of this higher pressure. Adjacent pipes, not buried, but belonging to the network (e.g. pipes in ducts, valve chambers, road crossings above ground etc.) may be designed and installed according to this standard. This standard presupposes the use of treated water, which by softening, demineralization, de-aeration, adding of chemicals, or otherwise has been treated to effectively prevent internal corrosion and deposits in the pipes. NOTE - For further information on water qualities to be used in district heating pipe systems, see bibliographic entry [8]. This document is not applicable for such units as: a) pumps; b) heat exchangers; c) boilers, tanks; d) systems behind domestic substations.

Obsah

ČSN EN 12516-2 This European Standard specifies the method for the strength calculation of the shell with respect to internal pressure of the valve.

Obsah

ČSN EN ISO 21922 This document specifies safety requirements, certain functional requirements, and marking of valves and other components with similar bodies, hereinafter called valves, for use in refrigerating systems including heat pumps. This document includes requirements for valves with extension pipes. This document describes the procedure to be followed when designing valve parts subjected to pressure as well as the criteria to be used in the selection of materials. This document describes methods by which reduced impact values at low temperatures may be taken into account in a safe manner. This document applies to the design of bodies and bonnets for pressure relief devices, including bursting disc devices, with respect to pressure containment but it does not apply to any other aspects of the design or application of pressure relief devices. In addition, this document is applicable to valves with a maximum operating temperature not exceeding 200 °C and a maximum allowable pressure not exceeding 160 bar1). 1) 1 bar = 0,1 MPa.

Obsah

ČSN EN 16602-70-16 The scope of the document addresses the generic verification for all types of adhesive bonding for space applications including evaluation phases. This standard covers all aspects of the adhesive bonding lifetime such as assembly, integration and testing, on-ground acceptance testing, storage, transport, pre-launch, launch and in-flight environments. This standard does not cover requirements for: - Adhesive bonding used in EEE mounting on printed circuit boards (for this subject see ECSS-Q-ST-70-61) - Adhesive bonding used in hybrid manufacturing (for this subject see ESCC 2566000) - Adhesive bonding for cover-glass on solar cell assemblies (for this subject see ECSS-E-ST-20-08) - Design of adhesive joints (for this subject see ECSS-E-ST-32) - Long term storage and long term storage sample testing - Performance of adhesive bonds - Functional properties of adhesive joints - Co-curing processes - Life-time aging prediction, neither on ground (humidity) nor in-orbit (thermal cycling) This standard may be tailored for the specific characteristics and constrains of a space project in conformance with ECSS-S-ST-00.

Obsah

ČSN EN 12464-1 (36 0450) Tento dokument stanovuje požadavky na osvětlení pro vnitřní pracoviště z hlediska zrakové pohody a zrakového výkonu osob s normálním nebo korigovaným zrakem. Uvedeny jsou všechny běžné zrakové úkoly, včetně práce na zobrazovacích jednotkách (DSE, display screen equipment). Tento dokument stanovuje požadavky na řešení osvětlení pro většinu vnitřních pracovišť a přilehlých prostorů z hlediska kvantity a kvality osvětlení. K tomu jsou doplněna doporučení pro správnou osvětlovací praxi včetně zohlednění vizuálních i nevizuálních (neobrazových) potřeb z hlediska osvětlení. Tento dokument nestanovuje požadavky na osvětlení z hlediska bezpečnosti a zdraví pracovníků při práci a nebyl připraven na základě uplatnění článku 169 Smlouvy o fungování Evropské unie, ačkoliv požadavky na osvětlení uvedené v tomto dokumentu zpravidla splňují bezpečnostní požadavky. POZNÁMKA - Požadavky na osvětlení z hlediska bezpečnosti a zdraví pracovníků při práci mohou být obsaženy ve směrnicích založených na článku 169 Smlouvy o fungování Evropské unie, v národních právních předpisech členských států přejímajících tyto směrnice nebo v jiných národních právních předpisech členských států. Tento dokument neposkytuje konkrétní řešení ani neomezuje projektanty při využití nových metod nebo při použití inovativních zařízení. Osvětlení může být zajištěno denním světlem, elektrickým osvětlením nebo jejich kombinací. Tento dokument není určen pro osvětlení venkovních pracovišť ani pro osvětlení podzemních dolů nebo nouzové osvětlení. Pro venkovní pracoviště viz EN 12464-2 a pro nouzové osvětlení viz EN 1838 a EN 13032-3.

Obsah

ČSN EN 285+A1 Tato evropská norma stanovuje požadavky a příslušné zkoušky pro velké parní sterilizátory používané převážně ve zdravotnictví pro sterilizaci zdravotnických prostředků a jejich příslušenství umístěných v jednom nebo více sterilizačních modulech. Zkušební vsázky popsané v této evropské normě jsou zvoleny tak, aby reprezentovaly většinu vsázek (tj. balené zboží vyrobené z kovu, pryže a porézních materiálů) pro hodnocení parních sterilizátorů určených obecně ke sterilizaci zdravotnických prostředků. Specifické vsázky (např. těžké kovové předměty nebo dlouhé a/nebo úzké dutiny) však vyžadují jiné zkušební vsázky. Tato evropská norma platí pro parní sterilizátory konstruované tak, aby se do nich vmístil nejméně jeden sterilizační modul, nebo sterilizátory, jejichž sterilizační komora má objem nejméně 60 l. Tato evropská norma nestanovuje požadavky na velké parní sterilizátory určené k tomu, aby používaly, obsahovaly nebo byly vystaveny působení hořlavých látek nebo látek, které by mohly způsobit výbuch. Tato evropská norma nestanovuje požadavky pro zařízení určená ke zpracování biologického odpadu nebo lidských tkání. Tato evropská norma nepopisuje systém managementu kvality pro řízení všech fází výroby sterilizátorů.

Obsah

ČSN EN ISO 5840-1 This document is applicable to heart valve substitutes intended for implantation and provides general requirements. Subsequent parts of the ISO 5840 series provide specific requirements. This document is applicable to newly developed and modified heart valve substitutes and to the accessory devices, packaging, and labelling required for their implantation and for determining the appropriate size of the heart valve substitute to be implanted. ISO 5840-1 outlines an approach for verifying/validating the design and manufacture of a heart valve substitute through risk management. The selection of appropriate qualification tests and methods are derived from the risk assessment. The tests can include those to assess the physical, chemical, biological, and mechanical properties of heart valve substitutes and of their materials and components. The tests can also include those for preclinical in vivo evaluation and clinical evaluation of the finished heart valve substitute. ISO 5840-1 defines operational conditions for heart valve substitutes. ISO 5840-1 furthermore defines terms that are also applicable to ISO 5840-2 and ISO 5840-3. ISO 5840-1 does not provide requirements specific to homografts, tissue engineered heart valves (e.g. valves intended to regenerate in vivo), and heart valve substitutes designed for implantation in circulatory support devices. Some of the provisions of ISO 5840-1 can be applied to valves made from human tissue that is rendered non-viable. NOTE - A rationale for the provisions of ISO 5840-1 is given in Annex A.

Obsah

ČSN ETSI EN 301 908-10 V4.3.1 The present document applies to the following equipment types for IMT-FT. IMT-FT is the Digital Enhanced Cordless Telecommunications (DECT) system being a member of the ITU IMT-2000 family: a) Base Station (BS) (termed as Fixed Part (FP) throughout the present document) b) User Equipment (UE) (termed as Portable Part (PP) throughout the present document) c) Cordless Terminal Adapter (CTA) (specific type of UE) d) Repeater (termed as Wireless Relay Station (WRS) (FP and PP combined) throughout the present document) e) Hybrid Part (HyP) (a PP with capability to act as a FP to provide PP to PP communication) These radio equipment types can operate in all or any part of the frequency bands given in table 1. The IMT-FT (DECT) service frequency bands for transmitting and receiving for all elements are the parts of the IMT spectrum applicable for TDD operation, 1 900 MHz to 1 980 MHz and 2 010 MHz to 2 025 MHz. NOTE 1 - IMT-FT equipment may have a second mode for providing operation also in the DECT band 1 880 MHz to 1 900 MHz. Application of DECT in the band 1 880 MHz to 1 900 MHz is covered by ETSI EN 301 406 [i.7]. Details of the DECT Common Interface may be found in ETSI EN 300 175-1 [i.12], ETSI EN 300 175 parts 2 [1] to 3 [2], ETSI EN 300 175-4 [i.13], ETSI EN 300 175 parts 5 [3] to 6 [4] and ETSI EN 300 175 parts 7 [i.14] to 8 [i.15]. Further details of the DECT system may be found in ETSI TR 101 178 [i.1]. Information about ULE may be found in ETSI TS 102 939 1 [i.16] and ETSI TS 102 939-2 [i.17]. 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 2 - The relationship between the present document and essential requirements of article 3.2 of Directive 2014/53/EU [i.18] is given in annex A.