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血細胞分析儀用校準物檢測

發(fā)布日期： 2024-06-21 17:34:53 - 更新時間：2024年06月29日 15:22

血細胞分析儀用校準物檢測項目報價？??解決方案？??檢測周期？??樣品要求？

GB/T 16886.7-2015醫(yī)療器械生物學評價第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的檢測步驟以及確定器械是否可以出廠的方法。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

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

GB/T 30107-2013健康信息學 HL7 V3 參考信息模型

本標準規(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、類及其屬性,并給出了RIM的結(jié)構(gòu)詞表。本標準適用于健康信息學領(lǐng)域內(nèi)的標準制定以及醫(yī)療保健信息系統(tǒng)的研發(fā)與管理。

YY/T 0701-2021血液分析儀用校準物

本標準規(guī)定了血液分析儀用校準物(以下簡稱為校準物)的術(shù)語和定義、技術(shù)要求、試驗方法、標志、標簽和說明書、包裝、運輸和貯存。本標準適用于血液分析儀用校準物。本校準物只用于校準血液分析儀(又稱血細胞分析儀)的白細胞計數(shù)(WBC)、紅細胞計數(shù)(RBC)、血紅蛋白測定(HGB)、平均紅細胞容積(MCV)/紅細胞比容測定(HCT)、血小板計數(shù)(PLT)五個參數(shù)，從而建立血液分析儀測量結(jié)果的計量學溯源性。

YY/T 0702-2008血細胞分析儀用質(zhì)控物（品）

本標準規(guī)定了血細胞分析儀用質(zhì)控物(品)(以下簡稱為質(zhì)控物)的術(shù)語和定義、命名與分類、技術(shù)要求、試驗方法、檢驗規(guī)則、標志、標簽和說明書、包裝、運輸和貯存。本標準未給出質(zhì)控物的白細胞分類圖形的技術(shù)要求。本標準適用于血細胞分析儀用質(zhì)控物，質(zhì)控物用于監(jiān)控或評價血細胞分析儀(又稱血液分析儀）檢測結(jié)果的精密度。

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

本標準規(guī)定了衛(wèi)生行業(yè)醫(yī)療器械、儀器設備（商品、物資）的分類與代碼。本標準適用于衛(wèi)生行業(yè)各醫(yī)療、教學、科學研究和生物制品等單位對物資管理、計劃、統(tǒng)計及會計業(yè)務等使用。

WS/T 347-2011血細胞分析的校準指南

本標準規(guī)定了血細胞分析校準的技術(shù)要求。本標準適用于使用血液分析儀的臨床實驗室及相關(guān)部門。

WS/T 360-2011流式細胞術(shù)檢測外周血淋巴細胞亞群指南

本標準規(guī)定了流式細胞術(shù)檢測外周血淋巴細胞亞群(T細胞、B細胞、NK細胞、CD4+T細胞和CD8+T細胞)的技術(shù)要點,包括標本采集和運輸、免疫熒光染色技術(shù)、流式細胞儀檢測和分析、結(jié)果報告和審核等方面。

WS/T 406-2012臨床血液學檢驗常規(guī)項目分析質(zhì)量要求

本標準規(guī)定了臨床血液學檢驗常規(guī)項目（全血細胞計數(shù)和凝血試驗）的分析質(zhì)量要求及驗證方法。本標準適用于使用血液分析儀和血凝儀的臨床實驗室、室間質(zhì)量評價機構(gòu)或體外診斷企業(yè)的內(nèi)部質(zhì)量控制、外部質(zhì)量評價及檢測系統(tǒng)的性能驗證。

DIN 58932-5-2007血液學.血液中血細胞濃度的測定.第5部分:血小板濃度的測定用參考方法

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)療器械的生物學評估.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.