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Value assignment and uncertainty evaluation for certified reference gas mixtures 经认证的标准气体混合物的值赋值和不确定度评定
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-09-09 DOI: 10.1007/s00769-024-01614-w
Christina E. Cecelski, Jennifer Carney, Antonio Possolo

The procedures used to assign values to certified reference gas mixtures and to evaluate their associated uncertainties, which are described in ISO 6143, and that were variously improved by Guenther and Possolo (Anal Bioanal Chem 399:489–500, 2011. 10.1007/s00216-010-4379-z), are further enhanced by the following developments: (i) evaluating and propagating uncertainty contributions derived from comparisons with historical reference gas mixtures of similar nominal composition; (ii) recognizing and quantifying mutual inconsistency (dark uncertainty) between primary standard gas mixtures used for calibration; (iii) employing Bayesian procedures for calibration, value assignment, and uncertainty evaluations; and (iv) employing state-of-the-art methods of meta-analysis to combine cylinder-specific measurement results. These developments are illustrated in examples of certification of two gas mixture Standard Reference Materials developed by the National Institute of Standards and Technology (NIST, USA). These examples serve only to demonstrate the methods described in this contribution and do not replace any official measurement results delivered in the certificates of any reference materials developed by NIST.

用于给认证的参比气体混合物赋值并评估其相关不确定度的程序在ISO 6143中有描述,并由Guenther和Possolo (Anal Bioanal Chem 399:489-500, 2011)进行了各种改进。10.1007/s00216-010-4379-z),通过以下发展得到进一步加强:(i)评估和传播通过与具有类似名义成分的历史参考气体混合物的比较得出的不确定性贡献;(ii)识别和量化用于校准的主要标准气体混合物之间的相互不一致(暗不确定度);(iii)采用贝叶斯程序进行校准、赋值和不确定度评估;(iv)采用最先进的荟萃分析方法,结合圆柱体特定的测量结果。美国国家标准与技术研究所(NIST, USA)开发的两种气体混合物标准参考物质的认证示例说明了这些发展。这些示例仅用于演示本文中描述的方法,不取代NIST开发的任何参考材料证书中提供的任何官方测量结果。
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引用次数: 0
Quality control charts for short or long runs without a training phase. Part 2. Performances in the presence of a persistent systematic error and simultaneous small shifts in the mean and the variance 没有训练阶段的短跑或长跑的质量控制图。第2部分。存在持续的系统误差和同时存在均值和方差的小位移时的表现
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-09-04 DOI: 10.1007/s00769-024-01616-8
Manuel Alvarez-Prieto, Ricardo Páez-Montero

Sometimes, analytical laboratories receive requests with a small number of determinations and/or samples or outside the typical scope of analytical services. As a result, they may not have historical data on the performance of the required analytical procedures and/or appropriate reference materials. Under these conditions, it is difficult or uneconomical to use traditional quality control charts. This is the so-called start-up problem of these charts. Quesenberry’s Q charts are appropriate in these situations because they do not require a prior training phase. In the first part of this series of publications, the fundamentals and the algebraic expressions of the Q charts were presented for the individual measurements for the mean (four cases) and for the variance (two cases). This experimental study was carried out with data from quality control of mass fractions of Co in a serpentinite CRM and SiO2 in a laterite CRM, by ICP-OES. The performance of Q charts is discussed in two situations: when the analytical process showed a clear systematic error from the beginning and when small shifts in mean and variance occurred simultaneously. In the first situation, performances of Q charts for the mean depended on the case: two of them were very sensitive even in the short run and the other two were insensitive and useless. In the second situation, the Q charts showed delayed alarms, but with a comparable behavior to the chart for individual measurements and the moving range of two. EWMA charts associated to Q charts were an excellent complement.

有时,分析实验室会收到少量检测和/或样品的请求,或者在分析服务的典型范围之外。因此,他们可能没有所要求的分析方法和/或适当的参考材料的性能的历史数据。在这种情况下,使用传统的质量控制图是困难的或不经济的。这就是这些图表中所谓的启动问题。Quesenberry的Q图适用于这些情况,因为它不需要事先的培训阶段。在本系列出版物的第一部分中,介绍了均值(四种情况)和方差(两种情况)的单独测量的Q图的基本原理和代数表达式。本实验研究采用ICP-OES法对蛇纹岩CRM中Co和红土CRM中SiO2的质量分数进行质量控制。讨论了两种情况下Q图的性能:当分析过程从一开始就显示出明显的系统误差时,以及同时发生均值和方差的小位移时。在第一种情况下,均值的Q图的性能取决于情况:其中两个即使在短期内也非常敏感,而另外两个则不敏感且无用。在第二种情况下,Q图显示延迟警报,但具有与单独测量和两个移动范围的图表相似的行为。与Q图相关联的EWMA图是一个很好的补充。
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引用次数: 0
Promotion of metrological traceability through the provision of a metrologically traceable proficiency testing reference value for the mass fraction of benzoic acid in fish sauce 通过提供鱼露中苯甲酸质量分数的计量可追溯能力测试参考值,促进计量可追溯性
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-09-04 DOI: 10.1007/s00769-024-01618-6
Jasmine Po-Kwan Lau, Alvin Wai-Hong Fung

The present paper outlines a joint proficiency testing (PT) programme established between the Asia–Pacific Metrology Programme (APMP) and the Asia Pacific Accreditation Cooperation (APAC). This programme aims to assess the analytical performance and enhance measurement proficiencies in laboratories across various economies, with a focus on the quantification of benzoic acid in fish sauce. This PT programme was organised by the Government Laboratory, the designated institute of metrology in chemistry for Hong Kong, China (GLHK). A comprehensive invitation extended to both APMP and non-APAC members resulted in the participation of 41 laboratories from 19 different economies. The metrological reference value for benzoic acid, provided by GLHK, was determined utilizing isotope-dilution mass spectroscopy (IDMS) with traceability to the International System of Units (SI). This SI-traceable reference value enhances the quality of participants’ measurements and promotes the awareness of traceability among the participants, enabling a more accurate evaluation of their results. Concurrently, this approach facilitates the building of measurement capabilities among participants, fostering more robust connections between metrology institutes and testing laboratories. The programme also revealed a notable deficiency in the understanding of statistical concepts among some participants, including the coverage factor, degrees of freedom, standard uncertainty, and expanded uncertainty. Proper interpretation of zeta-scores or En scores based on measurement uncertainties, when analysed alongside z-scores, proves to be indispensable for an accurate assessment of the participants’ measurement competencies and their ability to evaluate measurement uncertainty. The assessment of participants’ performances, taking into account measurement uncertainties, serves as a benchmark for participants to gauge the validity of their measurement uncertainty evaluations.

本论文概述了亚太计量计划(APMP)和亚太认可合作组织(APAC)之间建立的联合能力测试(PT)计划。该计划旨在评估分析性能并提高不同经济体实验室的测量熟练程度,重点是鱼露中苯甲酸的定量。此培训计划由政府化验所主办,该化验所是中国香港指定的化学计量研究所。向APMP和非apac成员发出的全面邀请导致来自19个不同经济体的41个实验室参与。利用同位素稀释质谱法(IDMS)测定了由GLHK提供的苯甲酸的计量参考值,并可溯源至国际单位制(SI)。这种si可追溯的参考值提高了参与者测量的质量,并促进了参与者对可追溯性的认识,从而能够更准确地评估他们的结果。同时,这种方法促进了参与者之间测量能力的建立,在计量机构和测试实验室之间建立了更强大的联系。该方案还显示出一些参与者对统计概念的理解明显不足,包括覆盖系数、自由度、标准不确定度和扩大不确定度。当与z分数一起分析时,基于测量不确定性的ζ分数或En分数的正确解释被证明是准确评估参与者的测量能力和他们评估测量不确定性的能力所不可或缺的。考虑测量不确定度的参与者绩效评估是参与者衡量其测量不确定度评估有效性的基准。
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引用次数: 0
A fit-for-purpose nongaseous impurity assay procedure for potential inorganic primary reference materials by inductively coupled plasma mass spectrometry
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-09-02 DOI: 10.1007/s00769-024-01617-7
Jong Wha Lee, Hyung Sik Min, Jinil Kim, Kyoung-Seok Lee

Purity-evaluated inorganic materials, which are potential primary reference materials (PRMs) in chemistry, are crucial to the production of inorganic calibration solutions with metrological traceability to the International System of Units (SI). Purity evaluation is typically performed by individually assaying all possible impurities (gaseous and nongaseous) in a material, but technical challenges and the lack of resources are creating bottlenecks in developing effective purity assay procedures. This study describes a nongaseous impurity assay procedure developed and used at Korea Research Institute of Standards and Science (KRISS) to evaluate the purities of inorganic PRMs. Inductively coupled plasma mass spectrometry (ICP-MS) is used to assay more than 60 impurity elements in a single day, and external glow discharge mass spectrometry (GDMS) data are used to complement ICP-MS data. All aspects of the impurity assay procedure, including sample preparation, instrument operation, and data treatment, are described in detail. It is shown that the procedure is applicable to high-purity Al, As, Cu, NaCl, Se, Si, and Zn, and that a target relative uncertainty of 0.005 % for purity values can be satisfied even if individual impurity data are quite uncertain. Particular emphasis is on clearly specifying the measurand and target uncertainty for developing a fit-for-purpose assay procedure, as they determine the acceptable level of assay quality and help preventing misinterpretation of assay results.

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引用次数: 0
Selection of bacterial strains in a testing microbiology laboratory for quality assurance purposes: ISO/IEC 17025:2017 standard point of view 用于质量保证目的的检测微生物实验室细菌菌株的选择:ISO/IEC 17025:2017标准观点
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-08-16 DOI: 10.1007/s00769-024-01615-9
Han-Min Ohn

Clause 6.5 of the ISO/IEC 17025:2017 standard describes the requirements for the metrological traceability of measurement results of a testing or calibration laboratory. Subclause 6.5.2 describes three ways to establish traceability to the International System of Units (SI). However, it is not technically possible to trace the bacterial strains used in a microbiology laboratory to the SI unit. So, when selecting a bacterial strain in a microbiology laboratory for quality assurance purposes, the laboratory needs to fulfill the subclause 6.5.3 (a) of the ISO/IEC 17025:2017 standard i.e., the laboratory needs to utilize a certified bacterial strain provided by a competent producer. So, when procuring a bacterial strain to fulfill this subclause, we need to ensure two points; (a) the bacterial strain is certified and (b) the producer is competent. A certified bacterial strain produces well-defined biochemical reactions and possesses a defined genomic sequence. There are various well-known certified bacterial strains, such as American Type Culture Collection (ATCC) strains, National Collection of Type Cultures (NCTC) strains etc. The laboratory also needs to make sure that the producer of these certified bacterial strains is competent, i.e. ISO 17034 accredited. Only when these two conditions are met, a microbiology laboratory can safely assume that it meets the requirements of subclause 6.5.3 (a) of the ISO/IEC 17025:2017 standard. For a particular bacterial species, from the vast number of strains available, the laboratory also needs to consider which specific strain to procure. The purpose of this article is to discuss why a testing microbiology laboratory needs bacterial reference materials and how it should select a bacterial reference material for quality assurance purposes from the ISO/IEC 17025:2017 standard point of view.

ISO/IEC 17025:2017标准第6.5条描述了测试或校准实验室测量结果的计量可追溯性要求。第6.5.2款描述了建立国际单位制(SI)可追溯性的三种方法。然而,从技术上讲,不可能将微生物实验室使用的细菌菌株追踪到SI单位。因此,当为质量保证目的在微生物实验室中选择菌株时,实验室需要满足ISO/IEC 17025:2017标准的6.5.3 (a)小节,即实验室需要使用由合格生产商提供的经认证的菌株。因此,当获得一种细菌菌株来满足这一条款时,我们需要确保两点;(a)菌株是经过认证的,(b)生产商是合格的。经鉴定的菌株产生明确的生化反应,并具有明确的基因组序列。有各种知名的认证菌株,如美国类型培养收集(ATCC)菌株,国家类型培养收集(NCTC)菌株等。实验室还需要确保这些经过认证的菌株的生产商是合格的,即通过了ISO 17034认证。只有当满足这两个条件时,微生物实验室才能安全地假设它符合ISO/IEC 17025:2017标准第6.5.3 (a)款的要求。对于一种特定的细菌,从大量可用的菌株中,实验室还需要考虑采购哪一种特定的菌株。本文的目的是从ISO/IEC 17025:2017标准的角度讨论为什么检测微生物实验室需要细菌标准物质,以及如何选择细菌标准物质以保证质量。
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引用次数: 0
Correction: Certification of the total element mass fractions in UME EnvCRM 03 soil sample via a joint research project 更正:通过联合研究项目认证 UME EnvCRM 03 土壤样本中的总元素质量分数
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-07-09 DOI: 10.1007/s00769-024-01611-z
Alper Isleyen, Suleyman Z. Can, Oktay Cankur, Betul Ari Engin, Jochen Vogl, Maren Koenig, Milena Horvat, Radojko Jacimovic, Tea Zuliani, Vesna Fajon, Aida Jotanovic, Luka Gaževic, Milena Milosevic, Maria Ochsenkuehn–Petropoulou, Fotis Tsopelas, Theopisti Lymberopoulou, Lamprini-Areti Tsakanika, Olga Serifi, Klaus M. Ochsenkuehn, Ewa Bulska, Anna Tomiak, Eliza Kurek, Zehra Cakılbahçe, Gokhan Aktas, Hatice Altuntas, Elif Basaran, Barıs Kısacık, Zeynep Gumus
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引用次数: 0
The optimization approach for uncertainty assessment of the heating value of aviation fuel 航空燃料热值不确定性评估的优化方法
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-07-03 DOI: 10.1007/s00769-024-01610-0
Zhaoming Zhou, Shangchun Wei, Zijun Song, Jiayang Li

Accurately determining the calorific value of aviation kerosene is crucial for optimizing aircraft engine efficiency and design testing. However, current measurement methods exhibit significant uncertainties, necessitating an assessment of the uncertainty associated with measuring the calorific value of aviation kerosene to establish precise results. The present paper introduces the oxygen bomb calorific value measurement method and the probability box model, proposing an improved aviation kerosene calorific value uncertainty evaluation method by combining it with the MCM method. An uncertainty evaluation model based on GUM method, MCM method, and improved MCM method is established in conjunction with experimental data. The analysis of different models demonstrates that the improved MCM method effectively considers the uncertainty of corresponding distribution parameters of variables based on their own uncertainties, providing a reliable approach for calculating the heating value uncertainty of aviation kerosene.

准确测定航空煤油的热值对优化飞机发动机效率和设计试验至关重要。然而,目前的测量方法显示出很大的不确定性,需要评估与测量航空煤油热值有关的不确定性,以确定精确的结果。本文介绍了氧弹热值测量方法和概率盒模型,并将其与MCM方法相结合,提出了一种改进的航空煤油热值不确定度评定方法。结合实验数据,建立了基于GUM法、MCM法和改进MCM法的不确定度评价模型。对不同模型的分析表明,改进的MCM方法在考虑变量自身不确定性的基础上,有效地考虑了相应分布参数的不确定性,为计算航空煤油热值不确定性提供了可靠的方法。
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引用次数: 0
Association between blood lead levels and socio-demographic factors among outpatient children in Ningbo, China 中国宁波门诊儿童血铅水平与社会人口因素的关系
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-06-24 DOI: 10.1007/s00769-024-01609-7
Chengbo Zhou, Wenbo Lu, Haiyan Qiu, Lihua Zhu, Jishan Zheng, Wenyuan Liu

Lead exposure is a well-known health concern, affecting children worldwide. We aim to assess children’s blood lead levels (BLLs), and the association of risk factors with elevated BLL in children since the phase-out of leaded gasoline. We enrolled 8085 outpatient children to assess their blood lead levels, and the associations with social-demographic factors. Social-demographic information was obtained by using questionnaires. Multivariable linear and logistic regression models were performed to explore the associations between social-demographic factors and elevated BLLs. The geometric mean BLL was 15.96 μg/L. The prevalence rates of elevated BLLs (≧ 100 μg/L and ≧ 50 μg/L) were 2.0 % and 10.9 %, respectively. BLLs in boys were higher than that in girls (P < 0.001). Girls had a lower risk of BLLs above 50 μg/L than boys (OR = 0.83, 95 % CI 0.71–0.96). Father’s occupation as a skilled laborer or professional worker and living in the suburbs significantly contributed to the elevated BLLs ( ≧ 50 μg/L), with the ORs of 1.39 (1.06–1.81), 1.33 (1.01–1.75) and 1.24 (1.02–1.50), respectively. Our results suggested that children who lived in suburbs and whose fathers were skilled laborers and professional workers were more likely to have BLLs above 50 μg/L.

铅暴露是众所周知的健康问题,影响着全世界的儿童。我们的目的是评估儿童的血铅含量(BLLs),以及自含铅汽油逐步淘汰以来儿童血铅含量升高与风险因素的关联。我们招募了 8085 名门诊儿童,以评估他们的血铅水平以及与社会人口因素的关联。社会人口学信息通过问卷调查获得。我们采用多变量线性回归和逻辑回归模型来探讨社会人口因素与血铅含量升高之间的关系。几何平均 BLL 为 15.96 微克/升。BLL 升高(≧ 100 μg/L 和 ≧ 50 μg/L)的发生率分别为 2.0 % 和 10.9 %。男孩的 BLL 值高于女孩(P < 0.001)。女孩的 BLL 超过 50 μg/L 的风险低于男孩(OR = 0.83,95 % CI 0.71-0.96)。父亲的职业是技术工人或专业工人以及居住在郊区也是导致儿童血清白蛋白升高(≧ 50 μg/L)的重要原因,OR 值分别为 1.39(1.06-1.81)、1.33(1.01-1.75)和 1.24(1.02-1.50)。我们的研究结果表明,居住在郊区、父亲是技术工人和专业工人的儿童,其血清胆固醇水平超过 50 μg/L 的可能性更大。
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引用次数: 0
AQbD enabled method development and quantification of asiaticoside in foam-based formulations AQbD使泡沫配方中积雪草苷的方法开发和定量成为可能
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-06-24 DOI: 10.1007/s00769-024-01608-8
Mohit Kumar, Anjali Pant, Shruti Chopra, Amit Bhatia

The purpose of this study was to develop a rapid, sensitive, and precise RP-HPLC (Reverse-Phase High-Performance Liquid Chromatography) method for the estimation of asiaticoside (AC) using the analytical quality by design (AQbD) approach. Initially, important AQbD prerequisites like analytical target profile (ATP) and critical analytical attributes (CAAs), such as theoretical plates and tailing factor, were defined. The final chromatographic conditions for the analysis of AC consist of stationary phase {A COSMOSIL 5C18-MS-II packed column (250 mm × 4.6 mm i.d, 5 µm)}, mobile phase was Smix {Methanol and Acetonitrile (40:25)}, and Orthophosphoric acid buffer (0.025 % OPA) in the ratio of 65:35 v/v at a flow rate of 1.0 mL/min and detection wavelength was 205 nm. The diversity in CAAs with different inputs was explained using the Ishikawa fishbone diagram. Taguchi design was selected as the first screening design to choose the critical material attributes (CMAs) that influence the method development. Subsequently, for more systematic optimization of the chromatographic technique and evaluation of CAAs, central composite design (CCD) was employed. In conclusion, the findings of the present study validated the utility of AQbD in the systemic design of a liquid chromatographic method with fine sensitivity for AC estimation in pharmaceutical products.

本研究的目的是建立一种快速、灵敏、精确的反相高效液相色谱(RP-HPLC)方法,利用设计质量法(AQbD)测定积雪草苷(AC)的含量。首先,定义了重要的AQbD先决条件,如分析目标剖面(ATP)和关键分析属性(CAAs),如理论板和尾尾因子。AC分析的最终色谱条件为:固定相{A COSMOSIL 5C18-MS-II填充柱(250 mm × 4.6 mm, 5µm)},流动相为Smix{甲醇和乙腈(40:25)},正磷酸缓冲液(0.025% OPA),比例为65:35 v/v,流速为1.0 mL/min,检测波长为205 nm。利用Ishikawa鱼骨图解释了不同投入条件下CAAs的多样性。选择田口设计作为第一个筛选设计,选择影响方法发展的关键材料属性(cma)。随后,为了更系统地优化色谱技术和评价CAAs,采用中心复合设计(CCD)。总之,本研究的结果验证了AQbD在系统设计一种具有良好灵敏度的药物中AC估计的液相色谱方法中的实用性。
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引用次数: 0
Proficiency tests for analysis of pesticide residues in kimchi cabbage and ginseng in South Korea from 2008 to 2020 2008 至 2020 年韩国泡菜卷心菜和人参中农药残留分析的能力测试
IF 0.8 4区 工程技术 Q4 CHEMISTRY, ANALYTICAL Pub Date : 2024-06-17 DOI: 10.1007/s00769-024-01605-x
Seonghee Ahn, Byungjoo Kim

From 2008 to 2020, the Ministry of Food and Drug Safety (MFDS) and the Korea Research Institute of Standards and Science (KRISS) jointly conducted a proficiency testing (PT) program for the analysis of pesticide residues in kimchi cabbage and ginseng powder. This collaborative effort marked a significant milestone in South Korea, being the first instance of employing metrologically traceable assigned values, determined via isotope dilution mass spectrometry (IDMS), in PT programs. The focus was on a selective range of pesticides, including diazinon, chlorpyrifos, p,p’-DDE, γ-HCH (lindane), α-endosulfan, and β-endosulfan. Each biennial PT program centered on two of these pesticides with participating laboratories reporting their mass fractions in provided samples. PT samples were prepared meticulously prepared in powder form by KRISS, ensuring homogeneity and stability, integral for the accuracy of the testing. The paper elaborates on the intricate processes involved in PT sample preparation and the rigorous assignment of values. To evaluate laboratory proficiency, the Horwitz equation was utilized as a general mode to set for standard deviations in proficiency assessment. An in-depth review of seven PT programs conducted over this period demonstrates the significant role these programs played in advancing the measurement competencies of laboratories, underscoring the novelty and impact of this long-term collaborative effort.

从 2008 年到 2020 年,韩国食品药品安全部(MFDS)和韩国标准与科学研究院(KRISS)联合开展了一项能力验证计划(PT),用于分析泡菜卷心菜和人参粉中的农药残留。这项合作在韩国具有重要的里程碑意义,它是首次在能力验证计划中采用同位素稀释质谱法(IDMS)确定的可计量溯源的分配值。该计划的重点是一系列选择性农药,包括二嗪农、毒死蜱、p,p'-DDE、γ-HCH(林丹)、α-硫丹和β-硫丹。每两年一次的 PT 计划都以其中的两种农药为中心,由参与实验室报告其在所提供样品中的质量分数。PT 样品由 KRISS 以粉末形式精心制备,以确保样品的均匀性和稳定性,这也是确保检测准确性不可或缺的一部分。论文详细阐述了 PT 样品制备和严格赋值的复杂过程。为了评估实验室能力,霍维茨方程被用作能力评估中设定标准偏差的一般模式。对这一时期开展的七项能力验证计划进行的深入回顾表明,这些计划在提高实验室测量能力方面发挥了重要作用,突出了这一长期合作努力的新颖性和影响力。
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引用次数: 0
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