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Uued standardid

ISO/TR 14283:2018
Hind 100,70 EUR
Implants for surgery -- Essential principles of safety and performance
ISO/TR 14283:2017 provides fundamental principles for the design and manufacture of active or non-active implants in order that each implant can achieve its intended purpose. ISO/TR 14283:2017 is often the case that instruments and other equipment are used in association with implants. These devices might be useful or even essential for the safe implantation and/or use of the implants. This document applies to implants, however, it also applies to associated instruments and equipment to the extent that the design and manufacture of the implants is intended to ensure the safe combination and use of the implants with such devices. Requirements for the safe operation and use of associated instruments and equipment are contained in other standards.
Asendab ISO/TR 14283:2004

ISO 21533:2018
Hind 49,50 EUR
Dentistry -- Reprocessable cartridge syringes for intraligamentary injections
ISO 21533:2018 specifies requirements and test methods for reprocessable cartridge syringes intended for intraligamentary injections. ISO 21533:2018 specifies requirements for cartridge syringes with ISO metric thread sizes, and only intended for intraligamentary injections. However, attention is drawn to the existence of a variety of syringes with imperial thread sizes (see Annex A).
Asendab ISO 21533:2003

ISO 15002:2008/Amd 1:2018
Hind 13,65 EUR
ISO 15002:2008 - Amendment
Amendment to ISO 15002:2008

ISO 11737-1:2018
Hind 134,84 EUR
Sterilization of health care products -- Microbiological methods -- Part 1: Determination of a population of microorganisms on products
ISO 11737-1:2018 specifies requirements and provides guidance on the enumeration and microbial characterization of the population of viable microorganisms on or in a health care product, component, raw material or package. NOTE 1 The nature and extent of microbial characterization is dependent on the intended use of bioburden data. NOTE 2 See Annex A for guidance on Clauses 1 to 9. ISO 11737-1:2018 does not apply to the enumeration or identification of viral, prion or protozoan contaminants. This includes the removal and detection of the causative agents of spongiform encephalopathies, such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. NOTE 3 Guidance on inactivating viruses and prions can be found in ISO 22442‑3, ICH Q5A(R1) and ISO 13022. ISO 11737-1:2018 does not apply to the microbiological monitoring of the environment in which health care products are manufactured.
Asendab ISO 11737-1:2006; ISO 11737-1:2006/Cor 1:2007

ISO 13408-2:2018
Hind 117,77 EUR
Aseptic processing of health care products -- Part 2: Sterilizing filtration
ISO 13408-2:2018 specifies requirements for sterilizing filtration as part of aseptic processing of health care products conducted in accordance with ISO 13408‑1. It also offers guidance to filter users concerning general requirements for set-up, validation and routine operation of a sterilizing filtration process. ISO 13408-2:2018 is not applicable to removal of viruses. Sterilizing filtration is not applicable to fluids that intentionally contain particles larger than the pore size of the filter (e.g. bacterial whole-cell vaccines). ISO 13408-2:2018 is not applicable to high efficiency particulate air (HEPA) filters. ISO 13408-2:2018 does not specify requirements for the development, validation and routine control of a process for removing the causative agents of spongiform encephalopathies such as scrapie, bovine spongiform encephalopathy and Creutzfeldt-Jakob disease. Specific recommendations have been produced in particular countries for the processing of materials potentially contaminated with these agents.
Asendab ISO 13408-2:2003

IEC TR 61948-3:2018
Hind 34,14 EUR
Nuclear medicine instrumentation - Routine tests - Part 3: Positron emission tomographs
IEC TR 61948-3:2018(E) describes test methods for Positron Emission Tomographs (PET). As part of quality control, this document is defining routine tests to be performed by the user of Positron Emission Tomographs to maintain proper operation conditions. The results of these routine tests are compared to the reference data determined during or after acceptance test. Methods used for acceptance tests are described in IEC 61675-1:2013. In addition, today a Positron Emission Tomograph often includes X-Ray equipment for Computed Tomography (CT). For this document, PET/CT hybrid devices are considered to be state of the art, dedicated Positron Emission Tomographs not including the X-ray component being special cases only. quality control tests specific to only the CT component of the PET/CT are described in IEC 61223-2-6. The CT scanner also is subject to a type test according to IEC 60601-1 and applicable collateral and particular standards. This second edition cancels and replaces the first edition published in 2005. This edition constitutes a technical revision. This edition includes the following significant technical changes with respect to the previous edition: a) a clause to check routine performance tests has been added, b) a test to check the accuracy of co-registration of PET and CT images has been added, c) a test to check image quality has been added, d) the test to check pixel size has been removed.
Asendab IEC/TR 61948-3:2005

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prEN ISO 20186-3
Identne ISO/DIS 20186-3; prEN ISO 20186-3
Tähtaeg 16.03.2018
Molecular in-vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood - Cellular RNA - Part 3: Isolated circulating cell free DNA from plasma (ISO/DIS 20186-3:2018)
This International Standard recommends the handling, documentation, storage and processing of venous whole blood specimens intended for circulating cell free DNA (ccfDNA) examination during the pre-examination phase before a molecular assay is performed. This International Standard covers specimens collected in venous whole blood collection tubes. This International Standard is applicable to molecular in vitro diagnostic examinations including laboratory developed tests performed by medical laboratories. It is also intended to be used by laboratory customers, in vitro diagnostics developers and manufacturers, but also pertains institutions and commercial organizations performing biomedical research, biobanks, and regulatory authorities. CcfDNA profiles can change significantly after blood collection from the donor (e.g., release of genomic DNA from white blood cells, ccfDNA fragmentation and ccfDNA quantity change). Therefore, special measures have to be taken to secure good quality blood samples for ccfDNA examination and storage. Different dedicated measures need to be taken for preserving blood genomic DNA, which are not described in this International Standard. Blood genomic DNA is covered in ISO 20185-2, Molecular in vitro diagnostic examinations — specifications for pre-examination processes for venous whole blood — Part 2: Isolated genomic DNA. NOTE CcfDNA obtained from blood by the procedures suggested in this document can contain DNA present in exosomes. Pathogen DNA present in blood is not covered by this International Standard. Different dedicated measures need to be taken for preserving DNA in circulating exosomes, which are not described in this International Standard. NOTE International, national or regional regulations or requirements may also apply to specific topics covered in this International Standard.
Keel: Inglise

prEN ISO 13017
Identne ISO/DIS 13017; prEN ISO 13017
Tähtaeg 16.03.2018
Dentistry - Magnetic attachments (ISO/DIS 13017:2018)
This document specifies requirements and test methods for assessing the applicability of dental magnetic attachments that provide retention, support and stabilization of removable prostheses (crowns and bridges, partial dentures and overdentures), superstructures of dental implants and orthodontic or maxillofacial prostheses including obturators.
Keel: Inglise