血细胞分析仪用校准物检测

发布时间：2024-06-21 作者：中析研究所浏览：

GB/T 16886.7-2015医疗器械生物学评价第7部分:环氧乙烷灭菌残留量

GB/T 16886的本部分规定了经环氧乙烷(EO)灭菌的单件医疗器械上EO及2-氯乙醇(ECH)残留物的允许限量、EO及ECH的检测步骤以及确定器械是否可以出厂的方法。资料性附录中还给出了其他背景信息，包括指南和本部分应用流程图。本部分不包括不与患者接触的经EO灭菌的器械(如体外诊断器械)。

GB/T 29025-2012粒度分析电阻法

本标准规定了电阻法测量分散于电解质溶液中颗粒粒度分布的方法。该方法适用于通过测量脉冲高度以及脉冲和颗粒体积或颗粒直径的相关性来得到粒度分布,测量范围约为0.4 µm~1 200 µm。尽管在本标准中没有提出特定材料的测量细节要求,但给出了如多孔材料和导电性材料金属粉末的粒度分析导则。

GB/T 30107-2013健康信息学 HL7 V3 参考信息模型

本标准规定了用于描述静态的健康和医疗保健信息的HL7参考信息模型(RIM),描述了HL7 RIM中的主题域、类及其属性,并给出了RIM的结构词表。本标准适用于健康信息学领域内的标准制定以及医疗保健信息系统的研发与管理。

YY/T 0701-2021血液分析仪用校准物

本标准规定了血液分析仪用校准物(以下简称为校准物)的术语和定义、技术要求、试验方法、标志、标签和说明书、包装、运输和贮存。本标准适用于血液分析仪用校准物。本校准物只用于校准血液分析仪(又称血细胞分析仪)的白细胞计数(WBC)、红细胞计数(RBC)、血红蛋白测定(HGB)、平均红细胞容积(MCV)/红细胞比容测定(HCT)、血小板计数(PLT)五个参数，从而建立血液分析仪测量结果的计量学溯源性。

YY/T 0702-2008血细胞分析仪用质控物（品）

本标准规定了血细胞分析仪用质控物(品)(以下简称为质控物)的术语和定义、命名与分类、技术要求、试验方法、检验规则、标志、标签和说明书、包装、运输和贮存。本标准未给出质控物的白细胞分类图形的技术要求。本标准适用于血细胞分析仪用质控物，质控物用于监控或评价血细胞分析仪(又称血液分析仪）检测结果的精密度。

WS/T 118-1999卫生行业药疗器械、仪器设备(商品、物资)分类与代码

本标准规定了卫生行业医疗器械、仪器设备（商品、物资）的分类与代码。本标准适用于卫生行业各医疗、教学、科学研究和生物制品等单位对物资管理、计划、统计及会计业务等使用。

WS/T 347-2011血细胞分析的校准指南

本标准规定了血细胞分析校准的技术要求。本标准适用于使用血液分析仪的临床实验室及相关部门。

WS/T 360-2011流式细胞术检测外周血淋巴细胞亚群指南

本标准规定了流式细胞术检测外周血淋巴细胞亚群(T细胞、B细胞、NK细胞、CD4+T细胞和CD8+T细胞)的技术要点,包括标本采集和运输、免疫荧光染色技术、流式细胞仪检测和分析、结果报告和审核等方面。

WS/T 406-2012临床血液学检验常规项目分析质量要求

本标准规定了临床血液学检验常规项目（全血细胞计数和凝血试验）的分析质量要求及验证方法。本标准适用于使用血液分析仪和血凝仪的临床实验室、室间质量评价机构或体外诊断企业的内部质量控制、外部质量评价及检测系统的性能验证。

DIN 58932-5-2007血液学.血液中血细胞浓度的测定.第5部分:血小板浓度的测定用参考方法

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

DIN EN ISO 15194-2009医用体外诊断装置.生物原始试样中数量值的测量.合格参考材料的要求和支持文件的内容(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技术报告.血小板诊断

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体外诊断医疗装置的性能评估

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医疗器械的生物学评估.环氧乙烷灭菌残留量

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.