11.100 实验室医学 标准查询与下载

DB22/T 2967-2019 人体尿液中可卡因的测定 液相色谱-高分辨质谱法

Determination of Cocaine in Human Urine by Liquid Chromatography-High Resolution Mass Spectrometry

DB22/T 2966-2019 人体尿液中甲基苯丙胺的测定 液相色谱-高分辨质谱法

Determination of methamphetamine in human urine by liquid chromatography-high resolution mass spectrometry

T/ZSYX 003-2019 医院病理学检查 医疗废物处理规范

本标准规定了医院病理学检查中医疗废物处理规范的防护穿戴、处理要求、处理流程。 本标准适用于医院病理学检查中产生的废物（液）收集、贮存等处理规范。

Pathology examination in hospital - Specification for treatment of medical waste

T/ZSYX 001-2019 医院病理学检查 标本送检规程

本标准规定了医院病理学检查中标本送检规程的术语和定义、要求。 本标准适用于医院病理学检查中病理标本送检、接收的管理规范

Pathology examination in hospital - Procedures for the submission of specimens

T/ZSYX 002-2019 医院病理学检查 会诊服务规范

本标准规定了医院病理学检查中会诊服务规范的术语和定义、仪容仪表、服务规范、接诊沟通、会诊规范、服务流程。 本标准适用于医院病理学检查中的会诊服务规范。

Pathology examination in hospital - Specification for consultation service

T/CSBT 008-2019 可经输血传播感染病原体核酸筛查技术要求

影响检测结果的关键因素；核酸检测试剂的性能；结果分析和核酸扩增产物引起假阳性的控制措施

Requirements for nucleic acid screening technology for transfusion transmitted pathogens

T/CSBT 004-2019 血站血液检测实验室质量监测指标

根据质量指标的相关规定、标准及指南，参照国内外其他行业的质量指标，在结合血站血液检测实验室过程技术特点的基础上，制定血站实验室质量指标，具体包括：总体类指标、过程类指标（检测前、检測中、检测后）、资源类指标（人员、设备、物料、方法、生物安全、信息和质量控制）。每项指标明确收集数据标准、计算公式、意义。三大类指标既相互独立，又有一定关联性。整体监控实验室的运行情况，为科学化、系统化分析实验室内部 运行状况、实施实验室之间能力比对提供数据支持，为实验室质量改进提供有效工具。

Quality monitoring indicators of blood testing laboratory in blood transfusion service

T/CSBT 007-2019 血站血液检测实验室室间质量评价要求

建立室间质量评价计划一般性要求、室间质量评价的组织和实施、室间质量评价技术要求、室间质量评价报告和结果利用

Requirements for external quality assessment of blood screening laboratory

ASTM F1841-19 连续流动血泵里溶血评定的标准操作规程

Standard Practice for Assessment of Hemolysis in Continuous Flow Blood Pumps

YY/T 1641-2018 医用生化培养箱

Medical biochemical incubator

WS/T 645.1-2018 临床常用免疫学检验项目参考区间第1部分：血清免疫球蛋白G、免疫球蛋白A、免疫球蛋白M、补体3、补体4

Reference intervals for commonly used clinical immunological test items Part 1: Serum immunoglobulin G, immunoglobulin A, immunoglobulin M, complement 3, complement 4

ASTM F2450-18 组织工程医疗产品用聚合支架微观结构评定的标准指南

1.1 This guide covers an overview of test methods that may be used to obtain information relating to the dimensions of pores, the pore size distribution, the degree of porosity, interconnectivity, and measures of permeability for porous materials used as polymeric scaffolds in the development and manufacture of tissue-engineered medical products (TEMPs). This information is key to optimizing the structure for a particular application, developing robust manufacturing routes, and providing reliable quality control data. 1.2 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Guide for Assessing Microstructure of Polymeric Scaffolds for Use in Tissue-Engineered Medical Products

ASTM F2382-18 在部分凝血活酶时间（PTT）上评估循环血液接触医疗器械材料的标准试验方法

1.1 This test method covers the screening of circulating blood-contacting device materials for their ability to induce blood coagulation via the intrinsic coagulation pathway. This assay should be part of the hemocompatibility evaluation for devices and materials contacting human blood, as per ANSI/ AAMI/ISO 10993-4. 1.2 All safety policies and practices shall be observed during the performance of this test method. 1.3 All plasma and any materials that had contact with plasma will be bagged in a biohazard bag, properly labelled with the contents, and disposed of by appropriate means. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories. 1.4 The normal pooled human plasma must have tested negative for Hepatitis B (HBV) or Human Immunodeficiency (HIV) viruses. The plasmas should be treated like any patient plasma using standard precautions. The plasma should be handled at the Biosafety Level 2 as recommended in the Centers for Disease Control/National Institutes of Health Manual Biosafety in Microbiological Laboratories. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Test Method for Assessment of Circulating Blood-Contacting Medical Device Materials on Partial Thromboplastin Time (PTT)

T/ZZB 0539-2018 胱抑素C测定试剂（盒）

本标准规定了胱抑素C测定试剂（盒）的术语和定义、组成、基本要求、技术要求、试验方法、检验规则、标识、标签、使用说明书、组配包装，运输贮存和质量承诺的要求。 本标准适用于全自动生化分析仪，基于免疫透射比浊法对人源样本中胱抑素C（又称胱氨酸蛋白酶抑制剂C，CYS-C等）进行定量测定的试剂（盒）。

Cystatin C test reagent kit

ASTM D6499-18 橡胶树天然橡胶（HNR）及其制品中抗原蛋白的免疫学测定的标准试验方法

1.1 This test method covers an immunological method to determine the amount of antigenic protein in Hevea Natural Rubber and its products using rabbit antisera specific for HNRL proteins. This immunoassay procedure quantitatively measures the level of antigenic latex proteins in solution using an inhibition format. The samples may include glove or other product extracts which have been collected in order to measure the HNR levels. Although this method detects antigenic proteins, it should not be considered as a measure of allergenic proteins. Correlation of protein/antigen levels with the level of allergenic proteins has not been fully established. 1.2 For the purpose of this test method, the range of protein will be measured in terms of microgram to milligram quantities. 1.3 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.4 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee.

Standard Test Method for Immunological Measurement of Antigenic Protein in Hevea Natural Rubber (HNR) and its Products

DB12/T 796-2018 疾控机构实验室质量管理规范

本标准适用于天津市具有检验检测资质的疾病预防控制机构实验室。

CDC Laboratory Quality Management Standards

ASTM F2103-18 作为生物医学和组织工程医疗产品应用的起始材料的壳聚糖盐的特性和试验的标准指南

1.1 This guide covers the evaluation of chitosan salts suitable for use in biomedical or pharmaceutical applications, or both, including, but not limited to, tissue-engineered medical products (TEMPS). 1.2 This guide addresses key parameters relevant for the functionality, characterization, and purity of chitosan salts. 1.3 As with any material, some characteristics of chitosan may be altered by processing techniques (such as molding, extrusion, machining, assembly, sterilization, and so forth) required for the production of a specific part or device. Therefore, properties of fabricated forms of this polymer should be evaluated using test methods that are appropriate to ensure safety and efficacy. 1.4 Warning—Mercury has been designated by EPA and many state agencies as a hazardous material that can cause central nervous system, kidney, and liver damage. Mercury, or its vapor, may be hazardous to health and corrosive to materials. Caution should be taken when handling mercury and mercury-containing products. See the applicable product Material Safety Data Sheet (MSDS) for details and EPA’s website (http://www.epa.gov/mercury/faq.htm) for additional information. Users should be aware that selling mercury or mercurycontaining products, or both, in your state may be prohibited by state law. 1.5 The values stated in SI units are to be regarded as standard. No other units of measurement are included in this standard. 1.6 This standard does not purport to address all of the safety concerns, if any, associated with its use. It is the responsibility of the user of this standard to establish appropriate safety, health, and environmental practices and determine the applicability of regulatory limitations prior to use. 1.7 This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 This guide is under the jurisdiction of ASTM Committee F04 on Medical and Surgical Materials and Devices and is the direct responsibility of Subcommittee F04.42 on Biomaterials and Biomolecules for TEMPs. Current edition approved June 1, 2018. Published August 2018. Originally approved in 2001. Last previous edition approved in 2011 as F2103 – 11. DOI: 10.1520/F2103-18. Copyright © ASTM International, 100 Barr Harbor Drive, PO Box C700, West Conshohocken, PA 19428-2959. United States This international standard was developed in accordance with internationally recognized principles on standardization established in the Decision on Principles for the Development of International Standards, Guides and Recommendations issued by the World Trade Organization Technical Barriers to Trade (TBT) Committee. 1 2. Referenced Documents

Standard Guide for Characterization and Testing of Chitosan Salts as Starting Materials Intended for Use in Biomedical and Tissue-Engineered Medical Product Applications

DB22/T 393-2018 保健用品卫生要求

Hygienic Requirements for Health Products

KS P ISO 10993-14-2017 医疗器械生物学评价第14部分:陶瓷降解产物的鉴定和定量

Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics

KS P ISO 10993-14:2017 医疗器械的生物学评估 第14部分：陶瓷降解产物的识别和量化

Biological evaluation of medical devices — Part14:Identification and quantification of degradation products from ceramics