血細(xì)胞分析儀用校準(zhǔn)物檢測(cè)

血細(xì)胞分析儀用校準(zhǔn)物檢測(cè)項(xiàng)目報(bào)價(jià)？??解決方案？??檢測(cè)周期？??樣品要求？

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GB/T 16886.7-2015醫(yī)療器械生物學(xué)評(píng)價(jià) 第7部分:環(huán)氧乙烷滅菌殘留量

GB/T 16886的本部分規(guī)定了經(jīng)環(huán)氧乙烷(EO)滅菌的單件醫(yī)療器械上EO及2-氯乙醇(ECH)殘留物的允許限量、EO及ECH的檢測(cè)步驟以及確定器械是否可以出廠(chǎng)的方法。資料性附錄中還給出了其他背景信息，包括指南和本部分應(yīng)用流程圖。本部分不包括不與患者接觸的經(jīng)EO滅菌的器械(如體外診斷器械)。

GB/T 29025-2012粒度分析 電阻法

本標(biāo)準(zhǔn)規(guī)定了電阻法測(cè)量分散于電解質(zhì)溶液中顆粒粒度分布的方法。該方法適用于通過(guò)測(cè)量脈沖高度以及脈沖和顆粒體積或顆粒直徑的相關(guān)性來(lái)得到粒度分布,測(cè)量范圍約為0.4 μm~1 200 μm。盡管在本標(biāo)準(zhǔn)中沒(méi)有提出特定材料的測(cè)量細(xì)節(jié)要求,但給出了如多孔材料和導(dǎo)電性材料金屬粉末的粒度分析導(dǎo)則。

GB/T 30107-2013健康信息學(xué) HL7 V3 參考信息模型

本標(biāo)準(zhǔn)規(guī)定了用于描述靜態(tài)的健康和醫(yī)療保健信息的HL7參考信息模型(RIM),描述了HL7 RIM中的主題域、類(lèi)及其屬性,并給出了RIM的結(jié)構(gòu)詞表。本標(biāo)準(zhǔn)適用于健康信息學(xué)領(lǐng)域內(nèi)的標(biāo)準(zhǔn)制定以及醫(yī)療保健信息系統(tǒng)的研發(fā)與管理。

YY/T 0701-2021血液分析儀用校準(zhǔn)物

本標(biāo)準(zhǔn)規(guī)定了血液分析儀用校準(zhǔn)物(以下簡(jiǎn)稱(chēng)為校準(zhǔn)物)的術(shù)語(yǔ)和定義、技術(shù)要求、試驗(yàn)方法、標(biāo)志、標(biāo)簽和說(shuō)明書(shū)、包裝、運(yùn)輸和貯存。本標(biāo)準(zhǔn)適用于血液分析儀用校準(zhǔn)物。本校準(zhǔn)物只用于校準(zhǔn)血液分析儀(又稱(chēng)血細(xì)胞分析儀)的白細(xì)胞計(jì)數(shù)(WBC)、紅細(xì)胞計(jì)數(shù)(RBC)、血紅蛋白測(cè)定(HGB)、平均紅細(xì)胞容積(MCV)/紅細(xì)胞比容測(cè)定(HCT)、血小板計(jì)數(shù)(PLT)五個(gè)參數(shù)，從而建立血液分析儀測(cè)量結(jié)果的計(jì)量學(xué)溯源性。

YY/T 0702-2008血細(xì)胞分析儀用質(zhì)控物（品）

本標(biāo)準(zhǔn)規(guī)定了血細(xì)胞分析儀用質(zhì)控物(品)(以下簡(jiǎn)稱(chēng)為質(zhì)控物)的術(shù)語(yǔ)和定義、命名與分類(lèi)、技術(shù)要求、試驗(yàn)方法、檢驗(yàn)規(guī)則、標(biāo)志、標(biāo)簽和說(shuō)明書(shū)、包裝、運(yùn)輸和貯存。本標(biāo)準(zhǔn)未給出質(zhì)控物的白細(xì)胞分類(lèi)圖形的技術(shù)要求。本標(biāo)準(zhǔn)適用于血細(xì)胞分析儀用質(zhì)控物，質(zhì)控物用于監(jiān)控或評(píng)價(jià)血細(xì)胞分析儀(又稱(chēng)血液分析儀）檢測(cè)結(jié)果的精密度。

WS/T 118-1999衛(wèi)生行業(yè)藥療器械、儀器設(shè)備(商品、物資)分類(lèi)與代碼

本標(biāo)準(zhǔn)規(guī)定了衛(wèi)生行業(yè)醫(yī)療器械、儀器設(shè)備（商品、物資）的分類(lèi)與代碼。 本標(biāo)準(zhǔn)適用于衛(wèi)生行業(yè)各醫(yī)療、教學(xué)、科學(xué)研究和生物制品等單位對(duì)物資管理、計(jì)劃、統(tǒng)計(jì)及會(huì)計(jì)業(yè)務(wù)等使用。

WS/T 347-2011血細(xì)胞分析的校準(zhǔn)指南

本標(biāo)準(zhǔn)規(guī)定了血細(xì)胞分析校準(zhǔn)的技術(shù)要求。本標(biāo)準(zhǔn)適用于使用血液分析儀的臨床實(shí)驗(yàn)室及相關(guān)部門(mén)。

WS/T 360-2011流式細(xì)胞術(shù)檢測(cè)外周血淋巴細(xì)胞亞群指南

本標(biāo)準(zhǔn)規(guī)定了流式細(xì)胞術(shù)檢測(cè)外周血淋巴細(xì)胞亞群(T細(xì)胞、B細(xì)胞、NK細(xì)胞、CD4+T細(xì)胞和CD8+T細(xì)胞)的技術(shù)要點(diǎn),包括標(biāo)本采集和運(yùn)輸、免疫熒光染色技術(shù)、流式細(xì)胞儀檢測(cè)和分析、結(jié)果報(bào)告和審核等方面。

WS/T 406-2012臨床血液學(xué)檢驗(yàn)常規(guī)項(xiàng)目分析質(zhì)量要求

本標(biāo)準(zhǔn)規(guī)定了臨床血液學(xué)檢驗(yàn)常規(guī)項(xiàng)目（全血細(xì)胞計(jì)數(shù)和凝血試驗(yàn)）的分析質(zhì)量要求及驗(yàn)證方法。本標(biāo)準(zhǔn)適用于使用血液分析儀和血凝儀的臨床實(shí)驗(yàn)室、室間質(zhì)量評(píng)價(jià)機(jī)構(gòu)或體外診斷企業(yè)的內(nèi)部質(zhì)量控制、外部質(zhì)量評(píng)價(jià)及檢測(cè)系統(tǒng)的性能驗(yàn)證。

DIN 58932-5-2007血液學(xué).血液中血細(xì)胞濃度的測(cè)定.第5部分:血小板濃度的測(cè)定用參考方法

The aim of the standard is to specify a reference method for the determination of thrombocytes in human blood.

DIN EN ISO 15194-2009醫(yī)用體外診斷裝置.生物原始試樣中數(shù)量值的測(cè)量.合格參考材料的要求和支持文件的內(nèi)容(ISO 15194:2009),DIN EN ISO 15194:2009-10的英文版本

This International Standard specifies requirements for certified reference materials and the content of theirsupporting documentation, in order for them to be considered of higher metrological order in accordance withISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards,secondary measurement standards and international conventional calibrators that function either ascalibrators or trueness control materials. This International Standard also provides requirements on how tocollect data for value determination and how to present the assigned value and its measurement uncertainty.This International Standard applies to certified reference materials with assigned values of differential orrational quantities. Annex A provides information on nominal properties and ordinal quantities.This International Standard does not apply to reference materials that are parts of an in vitro diagnosticmeasuring system, although it is possible that many elements are helpful.

DIN SPEC 58961-2013技術(shù)報(bào)告.血小板診斷

The objective of this Technical Report is to give a description of methods for thrombocyte functional analysis used in clinical laboratories. All aspects of the analyses for preanalytics, sample treatment procedures, reagent preparations, testing procedures and clinical applications should be defined. Methods principally used for the purposes of research as well as methods, which are rarely or never applied in clinical laboratories, are not adressed in this document.

BS EN 13612-2002體外診斷醫(yī)療裝置的性能評(píng)估

This European Standard applies to the performance evaluation of in vitro diagnostic medical devices (IVD MDs) including IVD MDs for self-testing. It specifies the responsibilities and general requirements for the planning, conduct, assessment and documentation of a performance evaluation study by the manufacturer. It does not apply to specific evaluation plans for certain IVD MDs or a specific use.\nNOTE For a selection of publications on specific evaluation plans see Bibliography.\nWhere a manufacturer maintains a quality system this standard addresses the compliance with \"design validation\" and \"design changes\" as described in EN ISO 9001, EN 46001 and EN 928 especially considering the nature and use of IVD MDs.\nIn particular, this standard applies to IVD MDs to\n- show evidence to notified bodies and national authorities by results of a performance evaluation that the IVD MD performs as claimed by the manufacturer,\n- establish adequate performance evaluation data originating from appropriate studies or resulting from available literature, and to\n- satisfy the requirements of a quality system for design validation.

BS EN ISO 10993-7-2008醫(yī)療器械的生物學(xué)評(píng)估.環(huán)氧乙烷滅菌殘留量

This part of ISO 10993 specifies allowable limits for residual ethylene oxide (EO) and ethylene chlorohydrin(ECH) in individual EO-sterilized medical devices, procedures for the measurement of EO and ECH, andmethods for determining compliance so that devices may be released. Additional background, includingguidance and a flowchart showing how this document is applied, are also included in the informative annexes.EO-sterilized devices that have no patient contact (e.g., in vitro diagnostic devices) are not covered by thispart of ISO 10993.

BS EN ISO 15194-2009體外診斷醫(yī)療器械.生物源樣品的數(shù)量測(cè)量.輔助文檔的認(rèn)證參考材料和內(nèi)容要求

This International Standard specifies requirements for certified reference materials and the content of theirsupporting documentation, in order for them to be considered of higher metrological order in accordance withISO 17511. It is applicable to certified reference materials classifiable as primary measurement standards,secondary measurement standards and international conventional calibrators that function either ascalibrators or trueness control materials. This International Standard also provides requirements on how tocollect data for value determination and how to present the assigned value and its measurement uncertainty.This International Standard applies to certified reference materials with assigned values of differential orrational quantities. Annex A provides information on nominal properties and ordinal quantities.This International Standard does not apply to reference materials that are parts of an in vitro diagnosticmeasuring system, although it is possible that many elements are helpful.