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实验室医学

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标准编号 标准名称 状态 发布日期
ISO 21151:2020 EN In vitro diagnostic medical devices -- Requirements for international harmonisation protocols establishing metrological traceability of values assigned to calibrators and human samples 现行 2020-05-25
ISO 17511:2020 EN In vitro diagnostic medical devices -- Requirements for establishing metrological traceability of values assigned to calibrators, trueness control materials and human samples 现行 2020-04-24
ISO/TS 10993-19:2020 EN Biological evaluation of medical devices-- Part 19:Physico-chemical, morphological and topographical characterization of materials 现行 2020-03-12
ISO 10993-7:2008/Amd 1:2019 EN Applicability of allowable limits for neonates and infants 现行 2019-12-09
ISO 10993-9:2019 EN Biological evaluation of medical devices-- Part 9:Framework for identification and quantification of potential degradation products 现行 2019-11-26
ISO 10993-15:2019 EN Biological evaluation of medical devices-- Part 15:Identification and quantification of degradation products from metals and alloys 现行 2019-11-26
ISO 20186-3:2019 EN Molecular in vitro diagnostic examinations -- Specifications for pre-examination processes for venous whole blood-- Part 3:Isolated circulating cell free DNA from plasma 现行 2019-09-25
ISO/TS 20914:2019 EN Medical laboratories - Practical guidance for the estimation of measurement uncertainty 现行 2019-07-29
ISO 20776-1:2019 EN Susceptibility testing of infectious agents and evaluation of performance of antimicrobial susceptibility test devices- Part 1:Broth micro-dilution reference method for testing the in vitro activity of antimicrobial agents against rapidly growing aerobic bacteria involved in infectious diseases 现行 2019-06-05
ISO 20916:2019 EN In vitro diagnostic medical devices - Clinical performance studies using specimens from human subjects - Good study practice 现行 2019-06-04
ISO 20186-1:2019 EN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood- Part 1:Isolated cellular RNA 现行 2019-02-19
ISO 20186-2:2019 EN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for venous whole blood- Part 2:Isolated genomic DNA 现行 2019-02-19
ISO/TS 21726:2019 EN Biological evaluation of medical devices - Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents 现行 2019-02-01
ISO 15195:2018 EN Laboratory medicine - Requirements for the competence of calibration laboratories using reference measurement procedures 现行 2018-12-20
ISO 20166-3:2018 EN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue- Part 3:Isolated DNA 现行 2018-12-14
ISO 20166-2:2018 EN Molecular in vitro diagnostic examinations - Specifications for pre-examinations processes for formalin-fixed and paraffin-embedded (FFPE) tissue- Part 2:Isolated proteins 现行 2018-11-30
ISO 20166-1:2018 EN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for formalin-fixed and paraffin-embedded (FFPE) tissue- Part 1:Isolated RNA 现行 2018-11-26
ISO 20184-1:2018 EN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue- Part 1:Isolated RNA 现行 2018-11-22
ISO 20184-2:2018 EN Molecular in vitro diagnostic examinations - Specifications for pre-examination processes for frozen tissue- Part 2:Isolated proteins 现行 2018-11-07
ISO/TR 10993-22:2017 EN Biological evaluation of medical devices- Part 22:Guidance on nanomaterials 现行 暂无
ISO/TR 10993-33:2015 EN Biological evaluation of medical devices- Part 33:Guidance on tests to evaluate genotoxicity - Supplement to ISO 10993-3 现行 暂无
ISO/TS 10993-19:2006 EN Biological evaluation of medical devicesPart 19:Physico-chemical, morphological and topographical characterization of materials 现行 暂无
ISO/TS 10993-20:2006 EN Biological evaluation of medical devicesPart 20:Principles and methods for immunotoxicology testing of medical devices 现行 暂无
ISO 14155:2011/Cor 1:2011 EN ISO 14155:2011/Cor 1:2011 EN 现行 暂无
ISO 10993-1:2009/Cor 1:2010 EN ISO 10993-1:2009/Cor 1:2010 EN 现行 暂无
ISO 10993-4:2002/Amd 1:2006 EN Biological evaluation of medical devicesPart 4:Selection of tests for interactions with blood 被代替 暂无
ISO 10993-7:2008/Cor 1:2009 EN ISO 10993-7:2008/Cor 1:2009 EN 现行 暂无
ISO/TS 22367:2008/Cor 1:2009 EN ISO/TS 22367:2008/Cor 1:2009 EN 现行 暂无
ISO 18385 EN Minimizing the risk of human DNA contamination in products used to collect, store and analyze biological material for forensic purposes - Requirements 现行 暂无
ISO 7713:1985 EN Laboratory glassware — Disposable serological pipettes 现行 暂无
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