1、AUTO01-A Laboratory automation: Specimen container/specimen carrire; approved standard 实验室自动化：标本容器 / 标本托架；批准标准 

2、AUTO02-A2 Laboratory automation: Bar codes for specimen container identification; Approved standard—Second edition 实验室自动化：标本容器标识条形码；批准标准 （第二版）

3、AUTO03-A2 Laboratory automation: Communications with automated clinical laboratory systems, instruments, devices, and information systems ; Approved standard— Second edition 实验室自动化：与自动化临床实验室系统、仪器、 设备和信息系统的通信；批准标准（第二版）

4、AUTO04-A Laboratory automation: Systems operational requirements, characteristics, and information elements; Approved standard 实验室自动化：系统操作要求、特征和信息元素； 批准标准

5、AUTO05-A Laboratory automation: Electromechanical interfaces ;Approved standard 实验室自动化：机电接口；批准标准

6、AUTO07-A Laboratory automation: Data content for specimen identification; Approved standard 实验室自动化：标本识别的数据内容；批准标准

7、AUTO08-P Protocols to validate laboratory information systems; Proposed guideline 确认实验室信息系统的协议；建议指南

8、AUTO09-A Remote access to clinical laboratory diagnostic devices via the internet; Approved standard 通过网络远程访问临床实验室诊断设备；批准标准 

9、AUTO10-A Autoverification of clinical laboratory test results; Approved guideline 临床实验室检测结果的自动验证；批准指南 

10、AUTO11-A2 Information technology security of in vitro diagnostic instruments and software systems;  Approved standard – Second edition 体外诊断仪器和软件系统信息技术安全；批准标 准（第二版）

11、AUTO12-A Specimen labels: Content and location, fonts, and label orientation; Approved standard 标本标签：内容、位置、字体和标签方向；批准 标准

12、AUTO13-A2 Laboratory instrument and data management systems: Design of software user interfaces and end-user software systems validation, operation, and monitoring; Approved guideline—Second edition 实验室仪器和数据管理系统：软件用户接口设计 及最终用户端软件系统的确认、操作及监控； 批准指南（第二版） 

13、LIS01-A2 Specification for low-level protocol to transfer messages between clinical laboratory instruments and computer systems; Approved standard-Second edition 临床实验室仪器和计算机系统间信息传递的初级 协议规范；批准标准（第二版） 

14、LIS2-A2 Specification for transferring information between clinical laboratory instruments and information systems; Approved standard—Second edition 临床实验室仪器和信息系统间信息传递的规范； 批准标准（第二版）

15、LIS3-A Standard guide for selection of a clinical laboratory information management system 临床实验室信息管理系统选择的标准指南

16、LIS4-A Standard guide for documentation of clinical laboratory computer systems 临床实验室计算机系统文件编制的标准指南 

17、LIS5-A Standard specification for transferring clinical observations between independent computer systems 在独立计算机系统间传递临床观察的标准规范 

18、LIS6-A Standard practice for reporting reliability of clinical laboratory information systems 临床实验室信息系统报告可靠性的标准实践

19、LIS7-A Standard specification for use of bar codes on specimen tubes in the clinical laboratory 临床实验室标本管条码使用的标准规范

20、LIS8-A Standard guide for functional requirements of clinical laboratory information management systems 临床实验室信息管理系统功能要求的标准指南

21、LIS9-A Standard guide for coordination of clinical laboratory services within the electronic health record environment and networked architectures 在电子健康记录环境和网络架构内协调临床实验 室服务的标准指南

22、C24-A3 Statistical quality control for quantitative measurement procedures: Principles and definitions; Approved guideline—Third edition 用于定量测定程序的统计学质量控制：原理和定 义；批准指南（第三版） 

23、C29-A2 Standardization of sodium and potassium ion-selective electrode systems to the flame photometric reference method; Approved standard—Second edition 钠和钾离子选择电极系统到火焰光度参考方法的 标准化；批准标准（第二版） 

24、C31-A2 Ionized calcium determinations: Precollection variables, specimen choice, collection, and handling; Approved guideline—Second edition 离子钙测定：采集前变异，标本选择，采集和处理； 批准指南（第二版）

25、C34-A3 Sweat testing: Sample collection and quantitative chloride analysis; Approved guideline—Third edition 汗液检验：样品采集和氯化物定量分析；批准指 南（第三版）

26、C37-A Preparation and validation of commutable frozen human serum pools as secondary reference materials for cholesterol measurement procedures; Approved guideline 制备和确认具有互通性的冰冻混合人血清作为二 级参考物质用于胆固醇测量程序；批准指南

26、C38-A Control of preanalytical variation in trace element determinations; Approved guideline 微量元素检测中分析前变异的控制；批准指南

27、C39-A A designated comparison method of the measurement of ionized calcium in serum; Approved standard 血清离子钙检测的指定对比方法，批准标准

28、C40-A2 Measurement procedures for the determination of lead concentrations in blood and urine; Approve guideline—Second edition 血液和尿液中检测铅浓度的测量程序；批准指南 （第二版） 

29、C42-A Erythrocyte protoporphyrin testing; Approved guideline 红细胞原卟啉检验；批准指南 

30、C43-A2 Gas chromatography/mass spectrometry confirmation of drugs; Approved guideline — Second edition 气相色谱/质谱法确认药物；批准指南（第二版） 

31、C44-A Harmonization of glycohemoglobin measurements; Approved guideline 糖化血红蛋白检测的一致化；批准指南（第二版）

32、C45-A Measurement of free thyroid hormones; Approved guideline 游离甲状腺激素的检测；批准指南

33、C46-A2 Blood gas and pH analysis and related measurements; Approved guideline—Second edition 血气和pH分析及相关检测；批准指南（第二版）

34、C48-A Application of biochemical markers of bone turnover in the assessment and monitoring of bone diseases; Approved guideline 在评估和监测骨骼疾病中骨转化生化指标的应 用；批准指南 

35、C49-A Analysis of body fluids in clinical chemistry; Approved guideline 临床化学中体液的分析；批准指南 

36、C50-A Mass spectrometry in the clinical laboratory: General principles and guidance; Approved guideline 临床实验室中的质谱技术：一般原则和指导；批 准指南

37、C52-A2 Toxicology and drug testing in the clinical laboratory; Approved guideline—Second edition 临床实验室中毒理学和药物检测；批准指南（第 二版）

38、C56-A Hemolysis, icterus, and lipemia/turbidity indices as indicators of interference in clinical laboratory analysis; Approved guideline 溶血、黄疸和脂血/ 浑浊指标作临床实验室分析 中干扰的指示剂；批准指南

39、C58-A Assessment of fetal Lung maturity by the lamellar body count; Approved guideline 通过板层小体计数评估胎儿肺成熟度；批准指南

40、C59-A Apolipoprotein immunoassays: Development and recommended performance characteristics; Approved guideline 载脂蛋白免疫分析；开发和推荐的性能特性；批 准指南 41、C60-A Blood alcohol testing in the clinical laboratory; Approved guideline 临床实验室血液酒精测试：批准指南

42、C61-A Determination of serum iron, total iron-binding capacity and percent transferrin saturation; Approved standard 血清铁、总铁结合力和转铁蛋白饱和度的检测； 批准标准

43、C62-A Liquid chromatography-Mass spectrometry methods; Approved guideline 液相色谱 - 质谱分析方法；批准指南

44、GP05-A3 Clinical laboratory waste management ; Approved guideline—Third edition 临床实验室废弃物管理；批准指南（第三版）

45、GP11-A Basic cost accounting for clinical services; Approved guideline 临床实验室基本成本核算；批准指南

46、GP15-A3 Cervicovaginal cytology based on the papanicolaou technique; Approved guideline— Third edition 基于巴氏技术的子宫颈阴道细胞学；批准指南（第 三版）

47、GP16-A3 Urinalysis; Approved guideline – Third edition 尿液分析；批准指南（第三版）

48、 GP17-A3 Clinical laboratory safety; Approved guideline – Third edition 临床实验室安全；批准指南（第三版）

48、GP20-A2 Fine needle aspiration biopsy(FNAB) techniques; Approved guideline—Second edition 细针穿刺抽吸活检（FNAB）技术；批准指南（第 二版）

49、GP23-A2 Nongynecological cytology specimens; Preexamination, examination, and postexamination processes; Approved guideline—Second edition 非妇科细胞学标本：检查前、检查中和检查后过程；批准指南（第二版） 

50、GP27-A2 Using proficiency testing to improve the clinical laboratory; Approved guideline— Second edition 利用能力验证改进临床实验室；批准指南（第二 版） 

52、GP28-A Microwave device use in the histology laboratory; Approved guideline 微波设备在组织学实验室中的使用；批准指南 

53、GP29-A2 Assessment of laboratory tests when proficiency testing is not available; Approved guideline—Second edition 能力验证不可用时实验室检测的评估；批准指南 （第二版）

54、GP31-A Laboratory instrument implementation, verification, and maintenance; Approved guideline 实验室仪器的安装启用、验证和维护保养；批准指南 

55、GP33-A Accuracy in patient and sample identification; Approved guideline 患者和样本识别的准确性；批准指南 

56、GP34-A Validation and verification of tubes for venous and capillary blood specimen collection; Approved guideline 静脉和毛细血管血液标本采集的确认和验证；批准指南

57、GP39-A6 Tubes and additives for venous and capillary blood specimen collection; Approved standard—Sixth edition 静脉和毛细血管血液标本采集管和添加剂；批准标准（第六版）

58、GP41-A6 Procedures for the collection of diagnostic blood specimens by venipuncture; Approved standard—Sixth edition 通过静脉穿刺采集诊断血液标本的程序；批准标准（第六版）

59、GP42-A6 Procedures and devices for the collection of diagnostic capillary blood specimens; Approved standard—Sixth edition 诊断毛细血管血液标本的采集程序和设备；批准 标准（第六版）

60、GP43-A4 Procedures for the collection of arterial blood specimens; Approved standard—Fourth edition 动脉血液标本的采集程序；批准标准（第四版）

61、GP44-A4 Procedures for the handling and processing of blood specimens for common laboratory tests; Approved guideline—Fourth edition 实验室常见检测用血液标本的处理和加工程序； 批准指南（第四版）

62、GP45-A Studies to evaluate patient outcomes; Approved guideline 评估患者治疗效果的研究：批准指南

63、GP46-R Planning for challenges to clinical laboratory operations during a disaster; A report 灾难期间临床实验室运营需要的规划；报告

64、H02-A5 Procedures for the erythrocyte sedimentation rate test; Approved standard—Fifth edition 红细胞沉降率测定程序；批准标准（第五版）

65、H07-A3 Procedure for determining packed cell volume by the microhematocrit method; Approved standard—Third edition 微量法红细胞比容测定程序；批准标准（第三版）

66、H15-A3 Reference and selected procedures for the quantitative determination of hemoglobin in blood; Approved standard—Third edition 血红蛋白定量测定参考和选择程序；批准标准（第 三版）

67、H20-A2 Reference leukocyte (WBC) differential count (proportional) and evaluation of instrumental methods; Approved standard—Second edition 白细胞分类计数（百分比）参考方法和仪器法的 评估；批准标准（第二版）

68、H21-A5 Collection, transport, and processing of blood specimens for testing plasma-based coagulation assays and molecular hemostasis assay; Approved standard—Second edition 血浆凝固试验和止血分子生物学检测全血标本的 采集、转运和处理；批准标准（第五版） 

69、H26-A2 Validation, verification, and quality assurance of automated hematology analyzers; Approved standard—Second edition 自动化血液分析仪的性能验证、确认和质量保证； 批准标准（第二版）

70、H30-A2 Procedure for the determination of fibrinogen in plasma; Approved guideline— Second edition 血浆纤维蛋白原测定程序；批准指南（第二版）

71、H42-A2 Enumeration of immunologically defined cell populations by flow cytometry; Approved guideline—Second edition 流式细胞术法免疫细胞分群计数；批准指南（第 二版） 72、H43-A2 Clinical flow cytometric analysis of neoplastic hematolymphoid cells; Approved guideline—Second edition 血液和淋巴系统肿瘤细胞的临床流式细胞分析； 批准指南（第二版）

73、H44-A2 Methods for reticulocyte counting (automated blood cell counters, flow cytometry and supravital dyes); Approved guideline—Second edition 网织红细胞计数方法（自动血细胞分析仪法、流 式细胞术和体外活体染色法）；批准指南（第 二版）

74、I/LA02-A2 Quality assurance of laboratory tests for autoantibodies to nuclear antigens: ① Indirect fluorescence assay for microscopy and ② Microtiter enzyme immunoassay methods; Approved guideline—Second edition 自身核抗体实验室检测的质量保证：①应用显微 镜的间接免疫荧光检测②微量滴定酶联免疫分 析法；批准指南（第二版） 

75、I/LA18-A2 Specifications for immunological testing for infectious diseases; Approved guideline—Second edition 免疫法检测感染性疾病的特性；批准指南（第二 版） 

76、I/LA20-A2 Analytical performance characteristics and clinical utility of immunological assays for human immunoglobulin E (IgE) antibodies and defined allergen specificities; Approved guideline—Second edition 免疫学方法检测人IgE 抗体的分析性能和临床应 用以及已知过敏原的特性；批准指南（第二版） 

77、I/LA 21-A2 Clinical evaluation of immunoassays; Approved guideline—Second edition 免疫学方法的临床评估；批准指南（第二版） 

78、I/LA 23-A Assessing the quality of immunoassay systems: Radioimmunoassays and enzyme, fluorescence, and luminescence immunoassays 免疫分析系统的质量评估：放射、酶、荧光、发光免疫分析法；批准指南 

79、I/LA25-A2 Maternal serum screening; Approved standard—Second edition 孕期血清筛查：批准标准（第二版）

80、 I/LA 26-A2 Performance of single cell immune response assays; Approved guideline—Second edition 单细胞免疫反应测定性能；批准指南（第二版） 

81、I/LA 28-A2 Quality assurance for design control and implementation of immunohistochemistry assays; Approved guideline—Second edition 免疫组化分析的设计、控制和执行的质量保证； 批准指南（第二版） 

82、I/LA 29-A Detection of HLA-specific alloantibody by flow cytometry and solid phase assays: Approved guideline 应用流式细胞仪和固相法检测HLA 特异性同种异体抗体：批准指南 

83、I/LA 30-A Immunoassay interference by endogenous antibodies; Approved guideline 内源抗体对免疫分析的干扰；批准指南 

84、I/LA33-A Validation of automated systems for immunohematological testing before implementation; Approved guideline 自动免疫血液学检测系统使用前的验证；批准指南

85、I/LA 34-A Design and validation of immunoassays for assessment of human allergenicity of new biotherapeutic drugs; Approved guideline 免疫方法评估新型生物医药的人体致敏性：设计 和验证；批准指南

86、EP05-A3 Evaluation of precision of quantitative measurement procedures; Approved guideline—Third edition 定量测量程序精密度的评估；批准指南

87、EP06-A Evaluation of the linearity of quantitative measurement procedures: A statistical approach; Approved guideline 定量测量程序的线性评估：统计学方法；批准 指南

88、EP07-A2 Interference testing in clinical chemistry; Approved guideline—Second edition 临床化学中干扰试验；批准指南（第二版）

89、EP09-A3 Measurement procedure comparison and bias estimation using patient samples;Approved guideline—Third edition 利用患者样本进行测量程序比对和偏差估计: 批 准指南（第三版）

90、EP10-A3 Preliminary evaluation of quantitative clinical laboratory measurement procedures; Approved guideline — Third edition 临床实验室定量测量程序的初步评估；批准指南 （第三版）

91、EP12-A2 User protocol for evaluation of qualitative test performance; Approved guideline— second edition 评估定性试验性能的用户方案；批准指南（第二 版）

92、EP14-A3 Evaluation of commutability of processed samples; Approved guideline—Third edition 加工样本互通性的评估；批准指南（第三版）

93、EP15-A3 User verification of precision and estimation of bias; Approved guideline—Third edition 用户精密度验证和偏差估计；批准指南（第三版）

94、EP17-A2 Evaluation of detection capability for clinical laboratory measurement procedures; Approved guideline—Second edition 临床实验室测量程序检测能力的评估；批准指南 （第二版）

95、EP18-A2 Risk management techniques to identify and control laboratory error sources; Approved guideline—Second edition 风险管理技术来识别和控制实验室误差来源；批准指南（第二版）

96、EP19-R A framework for NCCLS evaluation protocols; A report NCCLS 评估方案框架；一个报告

97、EP21-A Estimation of total analytical error for clinical laboratory methods;Approved guideline 临床实验室方法总分析误差的评估；批准指南

98、EP23-ATM Laboratory quality control based on risk management; Approved guideline 基于风险管理的实验室质量控制；批准指南

99、EP24-A2 Assessment of the diagnostic accuracy of laboratory tests using receiver operating characteristic curves; Approved guideline —Second edition 利用受试者工作特征曲线评估实验室检测的诊断 正确性；批准指南（第二版）

100、EP25-A Evaluation of stability of in vitro diagnostic reagents;Approved guideline 体外诊断试剂稳定性的评估；批准指南

101、EP26-A User evaluation of between-reagent Lot Variation; Approved guideline 试剂批次间变异的用户评估；批准指南

102、EP27-A How to construct and interpret an error grid for quantitative diagnostic assays; Approved guideline 如何构建和解释定量诊断分析误差网格；批准指南

103、EP28-A3c Defining, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline—Third edition 临床实验室参考区间的定义、建立和验证；批准指南（第三版）

104、EP29-A Expression of measurement uncertainty in laboratory medicine; Approved guideline 检验医学测量不确定度的表达；批准指南

105、EP30-A Characterization and qualification of commutable reference materials for laboratory medicine; Approved guideline 检验医学互通性参考物质的特征描述和资格条件；批准指南 106、EP31-A-IR Verification of comparability of patient results within one health care system; Approved guideline（Interim revision） 验证患者结果在一个卫生保健系统内的可比性； 批准指南（临时修订版）

107、EP32-R Metrological traceability and its implementation; A report 计量学溯源及其实施；一个报告

108、M02-A12 Performance standards for antimicrobial disk susceptibility tests; Approved standard— Twelfth edition 抗菌药敏纸片测试性能标准；批准标准( 第十二 版 )

109、M06-A2 Protocols for evaluating dehydrated mueller-hinton agar; Approved standard—Second edition 脱水Mueller-Hinton 琼脂培养基检验规程；批准 标准 ( 第二版 )

110、M07-A10 Methods for dilution antimicrobial susceptibility tests for bacteria that grow aerobically; Approved standard—Tenth edition 需氧菌的抗菌药敏稀释试验方法；批准标准( 第 十版 )

111、M11-A8 Methods for antimicrobial susceptibility testing of anaerobic bacteria; Approved standard—Eighth edition 厌氧菌抗菌药物敏感性试验方法；批准标准( 第 八版 )

112、M15-A Laboratory diagnosis of blood-borne parasitic diseases; Approved guideline 血源性寄生虫病的实验室诊断；批准指南

113、M21-A Methodology for the serum bactericidal test; Approved guideline 血清杀菌试验方法；批准指南

114、M22-A3 Quality control for commercially prepared microbiological culture media; Approved standard—Third edition 商业化微生物培养基的质量控制；批准标准( 第 三版 )

115、M23-A3 Development of in vitro susceptibility testing criteria and quality control parameters; Approved guideline—Third edition 体外药敏试验标准和质量控制参数的发展；批准指南 ( 第三版 )

116、M24-A2 Susceptibility testing of mycbacteria, Nocardiae, and other aerobic actinomycetes; Approved standard—Second edition 分枝杆菌、诺卡放线菌和其他需氧放线菌的药敏试验；批准标准 ( 第二版 )

117、M26-A Methods for determining bactericidal activity of antimicrobial agents; Approved guideline 抗菌剂杀菌活性的确定方法；批准指南

118、M27-A3 Reference method for broth dilution antifungal susceptibility testing of Yeasts; Approved standard—Third edition 酵母菌培养基稀释真菌药敏试验的参考方法；批准标准 ( 第三版 )

119、M27-S4 Reference method for broth dilution antifungal susceptibility testing of yeasts; Fourth informational supplement 酵母菌培养基稀释真菌药敏试验的参考方法；第四次信息补遗

120、M28-A2 Procedures for the recovery and identification of parasites from the intestinal tract; Approved guideline—Second edition 肠道内寄生虫复苏和识别程序；批准指南( 第二 版 ) 121、M29-A4 Protection of laboratory workers from occupationally acquired infections; Approved guideline—Fourth edition 实验室工作者的职业感染保护；批准指南( 第四 版 ) 

122、M32-P Evaluation of lots of dehydrated Mueller-Hinton broth for antimicrobial susceptibility testing; Proposed guideline 批量脱水MH 肉汤培养基的抗生素敏感试验的评估；建议指南

123、M33-A Antiviral susceptibility testing: Herpes simplex virus by plaque reduction assay; Approved standard 抗病毒药物敏感性试验：空斑减数法测定的单纯性疱疹病毒；批准标准 124、M34-A Western blot assay for antibodies to Borreliaburgdorferi; Approved guideline 伯氏疏螺旋体抗体的蛋白印迹试验；批准指南

125、M35-A2 Abbreviated identification of bacteria and yeast; Approved guideline—Second edition 细菌和酵母菌的缩写标识；批准指南（第二版）

126、M36-A Clinical use and interpretation of serologic tests for Toxoplasma gondii; Approved guideline 刚地弓形体血清学测试的临床应用与说明；批准指南

126、M38-A2 Reference method for broth dilution antifungal susceptibility testing of filamentous fungi; Approved standard—Second edition 丝状真菌培养基稀释抗真菌药物敏感性试验参考方 法；批准标准 ( 第二版 )

127、M39-A4 Analysis and presentation of cumulative antimicrobial susceptibility test data; Approved guideline—Fourth edition 累积抗菌敏感性试验数据的分析和表示；批准指南 ( 第四版 )

128、M40-A Quality control of microbiological transport systems; Approved standard 微生物运输系统的质量控制；批准标准

129、M41-A Viral culture; Approved guideline 病毒培养；批准指南

130、M43-A Methods for antimicrobial susceptibility testing for human mycoplasmas; Approved guideline 人支原体抗菌药物敏感性测试方法；批准指南

131、M44-A Method for antifungal disk diffusion susceptibility testing of Yeasts; Approved guideline 酵母的抗真菌纸片扩散敏感性试验方法；批准导则

132、M44A2 Method for antifungal disk diffusion susceptibility testing of Yeasts；Approved guidelines—Second edition  酵母抗真菌纸片扩散敏感性试验方法；批准指南(第 二版 )

133、M45-P Methods for antimicrobial dilution and disk susceptibility testing of infrequently isolated or fastidious bacteria; Proposed guideline 不频繁隔离细菌或难培养细菌的抗菌稀释和纸片敏感性试验方法；建议指导准则

134、M45-A2 Methods for antimicrobial dilution and disk susceptibility testing of infrequently isolated or fastidious bacteria; Approved guideline——Second edition 不常分离细菌或难养菌的抗菌稀释与纸片敏感性试 验方法；批准指南 ( 第二版 )

135、M47-A Principles and procedures for blood cultures; Approved guideline 血液培养的原则及程序；批准指南 

136、M48-A Laboratory detection and identification of mycobacteria; Approved guideline 分枝杆菌的实验室检测与鉴定；批准指南 

137、M49-P Methods for broth dilution susceptibility testing of bacteria isolated from aquatic animals; Proposed guideline 从水生动物分离的细菌的肉汤稀释药敏试验方法； 建议指南 138、M50-A Quality control for commercial microbial identification systems; Approved guideline 商用微生物鉴定系统的质量控制；批准指南 

139、M51-A Method for antifungal disk diffusion susceptibility testing of nondermatophyte filamentous fungi; Approved guideline 非皮肤真菌丝状真菌的抗菌纸片扩散法药物敏感性 测试的方法；批准指南

140、M53-A Criteria for laboratory testing and diagnosis of human immunodeficiency virus infection; Approved guideline 人类免疫缺陷病毒感染的实验室测试和诊断标准； 批准指南 141、M54-A Principles and procedures for detection of fungi in clinical specimens—Direct examination and culture; Approved guideline 临床样品中真菌检测的原理和程序——直接检测和培养；批准指南

142、M55-R Surveillance for methicillin-resistant staphylococcus aureus: Principles, practices, and challenges; A report 耐甲氧西林金黄色葡萄球菌的监测：原理，实践和挑战；报告

143、M56-A Principles and procedures for detection of anaerobes in clinical specimens; Approved guideline 临床样品中厌氧菌的检测原理和方法；批准指南

147、M100-S16 Performance standards for antimicrobial susceptibility testing; Sixteenth informational supplement 抗菌敏感性试验性能标准；第 16 次信息补充

148、M100S25 Performance standards for antimicrobial susceptibility testing; Twenty-fifth informational supplement 抗菌敏感性试验的绩效标准；第 25 次信息补充

149、MM01-A Molecular diagnostic methods for genetic diseases;Approved guideline 遗传疾病的分子诊断方法；批准指南

150、MM01-A3 Molecular methods for clinical genetics and oncology testing；Approved guideline—Third edition 临床遗传学与肿瘤学试验的分子方法；批准指南（第 三版）

151、MM02-A2 Immunoglobulin and t-cell receptor gene rearrangement assays; Approved guideline—Second edition 免疫球蛋白和T 细胞受体基因重排分析；批准指南 （第二版）

152、MM03-P2 Molecular diagnostic methods for infectious diseases; Proposed guideline—Second edition 传染病分子诊断方法；建议指导原则（第二版）

153、MM03-Ed3 Molecular diagnostic methods for infectious diseases 传染病的分子诊断方法（第三版）

154、MM04-A Quality assurance for immunocytochemistry; Approved guideline 免疫细胞化学的质量保证；批准指南

155、MM05-A Nucleic acid amplification assays for molecular hematopathology; Approved guideline 分子血液病理学的核酸扩增分析；核准指导原则

156、MM05A2 Nucleic acid amplification assays for molecular hematopathology; Approved guideline—Second edition 分子血液病理学核酸扩增检验；批准指南（第二版)

157、MM06-A Quantitative molecular methods for infectious diseases; Approved guideline 传染病的定量分析方法；核准指导原则 

158、MM06A2 Quantitative molecular methods for infectious diseases; Approved guideline— Second edition 传染病的定量分子方法；批准指南 ( 第二版） 

159、MM07-A Fluorescence in situ hybridization (fish) methods for medical genetics; Approved guideline 医学遗传学荧光原位杂交（FISH）方法；核准指导原则 

160、MM07A2 Fluorescence in situ hybridization methods for clinical laboratories; Approved guideline—Second edition  临床实验室荧光原位杂交方法；批准指南（第二版）

161、MM09-A  Nucleic acid sequencing methods in diagnostic laboratory medicine; Approved guideline 诊断实验室医学中的核酸排序方法；核准指导原则

162、MM09A2 Nucleic acid sequencing methods in diagnostic laboratory medicine； Approved guideline—Second edition  诊断实验室医学中的核酸测序方法；批准指南（第 二版） 

163、MM10-P Genotyping for infectious diseases: Identification and characterization; Proposed guideline 传染病基因分型：识别与表征；建议指导原则 

164、MM10A Genotyping for infectious diseases: Identification and characterization; Approved guideline 传染病基因分型：识别与表征；批准指南 

165、MM11-A Molecular methods for bacterial strain typing；Approved guideline—First edition 菌株分型的分子生物学方法；批准指南（第一版） 

166、MM12-P Diagnostic nucleic acid microarrays; Proposed guideline 诊断核酸微阵列；建议指导原则

167、MM12AF Diagnostic nucleic acid microarrays; Approved guideline 诊断核酸微阵列；批准指南

168、MM13-A Collection, transport, preparation, and storage of specimens for molecular methods; Approved guideline 用于分子方法的样本的收集、运输、制备和存储； 批准指南

169、MM14-A Proficiency testing (external quality assessment) for molecular methods; Approved guideline 分子方法的熟练度测试（外部质量评估）；核准指导原则 

170、MM14A2 Design of molecular proficiency testing/external quality assessment; Approved guideline—Second edition 分子能力验证/ 外部质量评估设计；批准指南（第 二版） 

171、MM16-A Use of external RNA controls in gene expression assays; Approved guideline— First edition 基因表达检测中外源RNA 参照物的应用；批准指南（第一版） 

172、MM16-P Use of external RNA controls in gene expression assays; Proposed guideline 外部RNA 对照物在基因表达分析中的使用；建议 指导原则 

173、MM17-A Verification and validation of multiplex nucleic acid assays; Approved guideline— First edition 核酸多重检测的验证；批准指南（第一版）

174、MM18-A Interpretive criteria for identification of bacteria and fungi by DNA target sequencing; Approved guideline—First edition 通过DNA 靶序列识别细菌和真菌的标准；批准指 南（第一版）

175、MM19-A Establishing molecular testing in clinical laboratory environments; Approved guideline—First edition 在临床实验室环境下建立的分子检测；批准指南（第 一版）

176、MM20-A Quality management for molecular genetic testing; Approved guideline—First edition 分子遗传测试的质量管理；批准指南（第一版）

177、MM22-A Microarrays for diagnosis and monitoring of infectious diseases; Approved guideline—First edition 传染病的微阵列诊断与监测；批准指南（第一版）

178、NBS01-A6 Blood collection on filter paper for newborn screening programs; Approved standard—Sixth edition 新生儿血滤片筛查；批准标准（第六版）

179、NBS02-A2 Newborn screening follow-up; Approved guideline—Second edition 新生儿筛查随访；批准指南（第二版）

180、NBS03-A Newborn screening for preterm, low birth weight, and sick newborns; Approved guideline 早产、低出生体重和患病新生儿筛查；批准指南 

181、NBS04-A Newborn screening by tandem mass spectrometry; Approved guideline 串联质谱法筛查新生儿疾病；批准指南 

182、NBS05-A Newborn screening for cystic fibrosis; Approved guideline 新生儿囊性纤维化筛查；批准指南 

183、NBS06-A Newborn blood spot screening for severe combined immunodeficiency by measurement of t-cell receptor excision circles; Approved guideline 通过测定T 细胞受体切除环对新生儿进行血液筛查 以检测重症综合性免疫缺陷；批准指南

184、POCT01-A2 Point-of-care connectivity; Approved standard—Second edition 床边监护连接性；批准标准（第二版）

185、POCT02-A Implementation guide of POCT01 for health care providers; Approved guideline 医疗服务人员的 POCT01 实施指南；批准指南

186、POCT04-A2 Point-of-care in vitro diagnostic(IVD) testing; Approved guideline—Second edition 床旁体外诊断（IVD）检测；批准指南（第二版）

187、POCT05-A Performance metrics for continuous interstitial glucose monitoring; Approved guideline 连续间隙血糖监测的性能度量；批准指南

188、POCT07-A Quality management: Approaches to reducing errors at the point of care; Approved guideline 质量管理：减少床旁错误的方法；批准指南

189、POCT09-A Selection criteria for point-of-care testing devices; Approved guideline 床旁检测装置的选用标准；批准指南

190、POCT10-A2 Physician and nonphysician provider-performed microscopy testing; Approved guideline—Second edition 医生和非医学从业者进行提供者操作显微检测 （PPM）技术；批准指南（第二版）

191、POCT11-A2 Pulse oximetry; Approved guideline—Second edition 脉搏血氧计；批准指南（第二版）

192、POCT12-A3 Point-of-care blood glucose testing in acute and chronic care facilities; Approved guideline—Third edition 急性和慢性护理设施中的血糖即时检测；批准指南 （第三版）

193、POCT13A2 Glucose monitoring in settings without laboratory support；Approved guideline— Second edition 无实验室支持的环境中的葡萄糖监测；批准指南（第 二版）

194、POCT14-A Point-of-care monitoring of anticoagulation therapy; Approved guideline 抗凝治疗的即时监测；批准指南

195、QMS01-A4 Quality management system: A model for laboratory services; Approved guideline—Fourth edition 质量管理体系：一种实验室服务的模式；批准指南 （第四版）

196、QMS02-A6 Quality management system: Development and management of laboratory documents; Approved guideline—Sixth edition 质量管理体系：实验室文件的开发和管理；批准指 南（第六版）

197、QMS03-A3 Training and competence assessment; Approved guideline—Third edition 培训和能力评估；批准指南（第三版）

198、QMS04-A2 Laboratory design; Approved guideline—Second edition 实验室设计；批准指南（第二版）

199、QMS05-A2 Quality management system: Qualifying, selecting, and evaluating a referral laboratory; Approved guideline—Second edition 质量管理体系：委托实验室资格认定、选择和评估； 批准指南（第二版）

200、QMS06-A3 Quality management system: Continual improvement; Approved guideline—Third edition 质量管理体系：持续改进；批准指南（第三版）

201、QMS07-A2 Application of a quality management system model for respiratory services; Approved guideline—Second edition 在呼吸科中的应用质量管理体系模型：批准指南（第 二版）

202、QMS08-A2 Application of a quality management system model for medical imaging services; Approved guideline—Second edition 在医学影像部门中应用质量管理体系模型；批准指 南（第二版）

203、QMS09-A2 Application of a quality management system model for inpatient medication use; Approved guideline—Second edition 在住院患者用药中应用质量管理体系模型；批准指南（第二版）

204、QMS10-A A Model for managing medical device alerts (hazards and recalls) for healthcare organizations; Approved guideline 医疗机构用于管理医疗设备报警（风险和召回）的模型；批准指南

205、QMS11-A Management of nonconforming laboratory events; Approved guideline 不合格实验室事件的管理；批准指南

206、QMS12-A Development and use of quality indicators for process improvement and monitoring of laboratory quality; Approved guideline 开发和使用质量指标用于实验室质量监测和流程改 进；批准指南

207、QMS13-A Quality management system: equipment; Approved guideline 质量管理体系：设备；批准指南

208、QMS14-A Quality management system: leadership and management roles and responsibilities; Approved guideline 质量管理体系：领导阶层与管理者的角色和职责； 批准指南

209、QMS15-A Assessments: Laboratory internal audit program; Approved guideline 评估：实验室内审计划；批准指南

210、QMS20-R Understanding the cost of quality in the laboratory; A report 理解实验室的质量成本；报告

211、VET01-A4 Performance standards for antimicrobial disk and dilution susceptibility tests for bacteria isolated from animals; Approved standard—Fourth edition 来源于动物的细菌菌株的抗菌盘与稀释药敏试验的 性能标准；批准标准（第四版）

212、VET02-A3 Development of in vitro susceptibility testing criteria and quality control parameters for veterinary antimicrobial agents; Approved guideline—Third edition 体外药敏试验标准的发展和兽用抗菌药物的质量控 制参数 ; 批准指南（第三版）

213、VET03-A Performance standards for antimicrobial susceptibility testing of bacteria isolated from aquatic animals; Second informational supplement 源自水生动物的细菌的抗菌药物敏感试验的性能标 准：第二次信息补充

214、VET03/ VET04-S2 Methods for antimicrobial disk susceptibility testing of bacteria isolated from aquatic animals; Approved guideline 源自水生动物的细菌的纸片扩散抗菌敏感性测试的 方法；批准指南

215、VET04-A2 Methods for broth dilution susceptibility testing of bacteria isolated from aquatic animals; Approved guideline—Second edition 培养基稀释法对水生生物中分离的细菌进行药敏试验；批准指南（第二版）

216、VET05-R Generation, presentation, and application of antimicrobial susceptibility test data for bacteria of animal origin; A report—First edition 动物源性细菌耐药性数据的产生、表现和应用；报告（第一版）