Normy

Obsah

ČSN EN 360 This document specifies requirements, test methods, marking, manufacturer's instructions and information for retractable type fall arresters (RTFAs) and applies to a RTFA with a single retractable lanyard and a RTFA with two retractable lanyards (twin RTFA) as components of one of the fall arrest systems covered by EN 363:2018. This European standard is not applicable to RTFAs and twin RTFAs used in any sport or recreational activity.

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ČSN EN 15267-4 This document specifies the general performance criteria and test procedures for the performance test of portable automated measuring systems (P-AMS) used for periodic measurements of stationary source emissions. It applies to the performance test of P-AMS based on measurement techniques specified by the standard reference method (SRM) or an alternative method (AM). The performance test is based on the general performance criteria and test procedures specified in this document and on the specific requirements specified for the SRM or AM. This includes testing of the applicability and correct implementation of the QA/QC procedures specified for the SRM or AM. This document supports the requirements of particular EU Directives.

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ČSN EN ISO 10993-17 Tato norma je rozsáhlou technickou revizí EN ISO 10993-17:2009. Specifikuje proces a požadavky na posuzování toxikologického rizika složek zdravotnických prostředků a metody a kritéria pro posouzení, zda expozice určitou složkou může způsobit poškození pacienta. Posuzování toxikologického rizika je součástí biologického hodnocení výrobku, jak je popsáno v souboru norem EN ISO 10993.

Obsah

ČSN P CEN/TS 17981-1 This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human DNA (somatic and germline) isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated DNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, circulating cell free DNA from plasma, and DNA from saliva. NOTE 1 - Typical applications include, but are not limited to, NGS for oncology, pharmacogenomics and clinical genetics; approaches include panels (e.g. disease panels, exome panels, target gene panels and in silico panels), exome and whole genome sequencing, as well as certain epigenetics and certain single-cell analyses. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organizations performing biomedical research. This document is not applicable for in situ sequencing, DNA-mediated protein sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 - International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

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ČSN P CEN/TS 17981-2 This document specifies requirements and gives recommendations for next generation sequencing (NGS) workflows for in vitro diagnostics and biomedical research. This document covers the pre-examination processes, human RNA isolation, sequencing library preparation, sequencing, sequence analysis and reporting of the examination of sequences for diagnostic purposes from isolated RNA from, e.g. formalin-fixed and paraffin embedded tissues, fresh frozen tissues, fine needle aspirates (FNA), whole blood, circulating tumour cells (CTCs), exosomes and other extracellular vesicles, and circulating cell free RNA from plasma. NOTE 1 - Typical applications include, but are not limited to, NGS for oncology and clinical genetics, certain single-cell analyses. This document is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories, molecular pathology laboratories and molecular genetic laboratories. This document is also applicable to laboratory customers, in vitro diagnostics developers and manufacturers, biobanks, institutions, and organisations performing biomedical research. This document is not applicable for in situ sequencing, forensic sequencing, sequencing of pathogens or microorganisms and microbiome analysis. NOTE 2 - International, national or regional regulations or requirements or multiples of them can also apply to specific topics covered in this document.

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ČSN EN 88-1+A1 EN 13611:2019, Clause 1 applies with the following modification and addition: Modification: The 1st paragraph of EN 13611:2019, Clause 1 is replaced by: This document specifies the safety, design, construction, and performance requirements and testing for pressure regulators and pneumatic gas/air ratio pressure regulators (zero pressure regulators are included as a special type of pneumatic gas/air ratio pressure regulators) for burners and appliances burning one or more gaseous fuels, hereafter referred to as "pressure regulators". This document is applicable to pressure regulators with declared maximum inlet pressures up to and including 50 kPa and of nominal connection sizes up to and including DN 250. Addition: This document is applicable to: - pressure regulators which use auxiliary energy; - pneumatic gas/air ratio pressure regulators, which function by controlling a gas outlet pressure in response to an air signal pressure, air signal differential pressure, and/or to a furnace pressure signal (zero pressure regulators are included as a special type of pneumatic gas/air ratio pressure regulators); - pneumatic gas/air ratio pressure regulators, which change an air outlet pressure in response to a gas signal pressure or a gas signal differential pressure. This document is not applicable to: - pressure regulators connected directly to a gas distribution network or to a container that maintains a standard distribution pressure; - pressure regulators intended for gas appliances to be installed in the open air and exposed to the environment; - mechanically linked gas/air ratio controls; - electronic gas/air ratio controls (EN 12067-2:2022). The 4th paragraph of EN 13611:2019, Clause 1 is removed.

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ČSN EN 1854+A1 EN 13611:2019, Clause 1 applies with the following modification: Modification: The 1st paragraph of EN 13611:2019, Clause 1 is replaced by: This document specifies the safety, design, construction, and performance requirements and testing of pressure sensing devices for burners and appliances burning one or more gaseous fuels. This document is applicable to pressure sensing devices for gaseous fuels, air, or combustion products with declared maximum inlet pressures up to and including 500 kPa. It applies to all types of pressure sensing devices, including electronic, differential and inferential types. It also specifies requirements for pressure sensing devices which are intended to be applied to steam boilers and as such need to meet increased reliability requirements. EN 13611:2019 Clause 1, 4th paragraph is not applicable.

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ČSN EN ISO 11979-7 This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

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ČSN EN ISO 4259-5 This document specifies statistical methodology for assessing the expected agreement between two test methods that purport to measure the same property of a material, and for deciding if a simple linear bias correction can further improve the expected agreement. This document is applicable for analytical methods which measure quantitative properties of petroleum or petroleum products resulting from a multi-sample-multi-lab study (MSMLS). These types of studies include but are not limited to interlaboratory studies (ILS) meeting the requirements of ISO 4259-1 or equivalent, and proficiency testing programmes (PTP) meeting the requirements of ISO 4259-3 or equivalent. The methodology specified in this document establishes the limiting value for the difference between two results where each result is obtained by a different operator using different apparatus and two methods X and Y, respectively, on identical material. One of the methods (X or Y) has been appropriately bias-corrected to agree with the other in accordance with this practice. This limit is designated as the between-methods reproducibility. This value is expected to be exceeded with a probability of 5 % under the correct and normal operation of both test methods due to random variation.

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ČSN EN ISO 21860 This document establishes the Reference Standards Portfolio (RSP) for the clinical imaging domain (as defined in Clause 4). An RSP lists the principle health information technology (HIT) standards that form the basis of implementing and deploying interoperable applications in the target domain. An RSP includes a description of the domain, a normative list of standards, and an informative framework for mapping the standards to example deployment use cases. The lists do not include standards that are specifically national in scope. The primary target audience for this document is policy makers (governmental or organizational), regulators, project planners and HIT managers. This document will also be of interest to other stakeholders such as equipment and HIT vendors, clinical and health information management (HIM) professionals and standards developers. The intended usage of this document is to inform decisions about selecting the standards that will form the basis of integration projects in geographic regions or healthcare organizations.

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ČSN EN ISO 12417-1 This document specifies requirements for vascular device-drug combination products (VDDCPs). With regard to safety, this document outlines requirements for intended performance, design attributes, materials, design evaluation, manufacturing, sterilization, packaging and information supplied by the manufacturer. For implanted products, this document is intended to be used as a supplement to ISO 14630, which specifies general requirements for the performance of non-active surgical implants. This document is intended to be used as a supplement to relevant device-specific standards, such as the ISO 25539 series specifying requirements for endovascular devices. Requirements listed in this document also address VDDCPs that are not permanent implants. NOTE 1 - Due to variations in the design of combination products covered by this document and due to the relatively recent development of some of these combination products, acceptable standardized in vitro test results and clinical study results are not always available. As further scientific and clinical data become available, appropriate revision of this document can be necessary. This document applies to delivery systems or parts of the delivery system that are an integral component of the vascular device and that are drug-covered (e.g. drug-covered balloon catheters and drug-covered guidewires). This document does not apply to devices whose PMOA provide a conduit for delivery of a drug (e.g. infusion catheters), unless they contain a drug component that is intended to have an ancillary action to the device part (e.g. antimicrobial coated infusion catheter). This document does not apply to procedures and devices used prior to and following the introduction of the VDDCP (e.g. balloon angioplasty devices) that do not affect the drug-related aspects of the device. This document does not provide a comprehensive pharmacological evaluation of VDDCPs. NOTE 2 - Some information about the requirements of certain national and regional authorities is given in Annex B. The connection of absorbable components of VDDCPs (e.g. coatings) with drug-related aspects of the device are addressed in this document. This document does not provide an exhaustive list of the degradation and other time-dependent aspects of absorbable implants and coatings. NOTE 3 - For more information on absorbable coatings, refer to ISO/TS 17137 and ASTM F3036-13. This document does not address issues associated with viable or non-viable biological materials such as tissues, cells or proteins. This document does not address issues associated with active surgical implants (i.e. implants that require power not generated by the human body or gravity).

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ČSN EN IEC 62282-6-101 This part of IEC 62282 covers micro fuel cell power systems and fuel cartridges that are wearable or easily carried by hand, providing direct current outputs that do not exceed 60 V DC and power outputs that do not exceed 240 VA. Portable fuel cell power systems that provide output levels that exceed these electrical limits are covered by IEC 62282-5-100.