Conformational Requirements Research Articles

Conformity of goods and transfer of risk in the international sales of goods: analysis under the rules of the CISG, Chinese law, and United Arab Emirates law

Abstract This article examines the relationship between the conformity of goods and risk transfer under the Civil Code of China, the UAE Civil Transactions Law, and the 1980 United Nations Convention on Contracts for the International Sale of Goods (CISG). The findings presented in this article consolidate the requirements of conformity of goods in the context of risk transfer between contracting parties and point out the variation between these legal documents in terms of the interpretation of the conformity of goods concept, which would play an influential role in the operation of the passing of risk. Furthermore, recommendations are offered for legislators in China and the United Arab Emirates to bridge the gap between their approaches and the international approach outlined in the CISG regarding the interpretation of the requirement of goods’ conformity in the context of risk transfer. These recommendations align with the international principle of harmonizing and unifying international commercial rules concerning risk transfer in international sale of goods contracts.

Interaction between material and process parameters during 3D concrete extrusion process

Extrusion of cement-based materials in additive manufacturing is influenced by a complex interaction of various material and process parameters. This study aims to investigate the impact of rheological properties and printing parameters on the extrudability of cement-based materials as well as the interaction between rheological properties of print materials and extrusion speed, as a key printing process parameter. 20 different print materials with diverse rheological properties were extruded at 10 different extrusion speeds. The effect of material parameters (i.e. rheological properties) and process parameters (i.e., extrusion speed) and their interaction during the extrusion process were evaluated using filament continuity, conformity and consistency. At a constant printing speed, a higher yield stress adversely impacted filament continuity in mixtures with a yield stress of over 260 Pa, whereas viscosity showed minimal influence on filament quality within the tested range of the rheological properties. The results of this study highlighted a significant correlation between material and process parameters and that adapting process parameters to variations in material properties is crucial for meeting printing criteria. The filament consistency of the mixtures with high yield stress was more sensitive to change in the extrusion speed than that of mixtures with low yield stress. An opposite trend, however, was observed for filament conformity where low yield stress mixtures showed a higher sensitivity to the extrusion speed. A procedure was suggested and applied to determine the optimum extrusion speed. Optimal extrusion speeds enabled printing mixtures with a broader spectrum of rheological properties with an acceptable visual quality, filament conformity and consistency requirements. With extrusion speed adjustment, the extrudability window was expanded from dynamic yield stress of 108–126 Pa to 108–263 Pa and plastic viscosity of 8.2–12.3 Pa.s to 5.1–16.4 Pa.s.

Data quality and timeliness analysis for post-vaccination adverse event cases reported through healthcare data exchange to FDA BEST pilot platform.

This study is part of the U.S. Food and Drug Administration (FDA)'s Biologics Effectiveness and Safety (BEST) initiative, which aims to improve the FDA's postmarket surveillance capabilities by using real-world data (RWD). In the United States, using RWD for postmarket surveillance has been hindered by the inability to exchange clinical data between healthcare providers and public health organizations in an interoperable format. However, the Office of the National Coordinator for Health Information Technology (ONC) has recently enacted regulation requiring all healthcare providers to support seamless access, exchange, and use of electronic health information through the interoperable HL7 Fast Healthcare Interoperability Resources (FHIR) standard. To leverage the recent ONC changes, BEST designed a pilot platform to query and receive the clinical information necessary to analyze suspected AEs. This study assessed the feasibility of using the RWD received through the data exchange of FHIR resources to study post-vaccination AE cases by evaluating the data volume, query response time, and data quality. The study used RWD from 283 post-vaccination AE cases, which were received through the platform. We used descriptive statistics to report results and apply 322 data quality tests based on a data quality framework for EHR. The volume analysis indicated the average clinical resources for a post-vaccination AE case was 983.9 for the median partner. The query response time analysis indicated that cases could be received by the platform at a median of 3 min and 30 s. The quality analysis indicated that most of the data elements and conformance requirements useful for postmarket surveillance were met. This study describes the platform's data volume, data query response time, and data quality results from the queried postvaccination adverse event cases and identified updates to current standards to close data quality gaps.

Transparent Recombination Layers Design and Rational Characterizations for Efficient Two-Terminal Perovskite-Based Tandem Solar Cells.

Two-terminal (2T) perovskite-based tandem solar cells (TSCs) arouse burgeoning interest in breaking the Shockley-Queisser (S-Q) limit of single-junction solar cells by combining two subcells with different bandgaps. However, the highest certified efficiency of 2T perovskite-based TSCs (33.9%) lags behind the theoretical limit (42-43%). A vital challenge limiting the development of 2T perovskite-based TSCs is the transparent recombination layers/interconnecting layers (RLs) design between two subcells. To improve the performance of 2T perovskite-based TSCs, RLs simultaneously fulfill the optical loss, contact resistance, carrier mobility, stress management, and conformal coverage requirements. In this review, the definition, functions, and requirements of RLs in 2T perovskite-based TSCs are presented. The insightful characterization methods applicable to RLs, which are inspiring for further research on the RLs both in 2T perovskite-based two-junction and multi-junction TSCs, are also highlighted. Finally, the key factors that currently limit the performance enhancement of RLs and the future directions that should be continuously focused on are summarized.

Recruitment of the 40S ribosomal subunit by the West Nile virus 3′ UTR promotes the cross-talk between the viral genomic ends for translation regulation

Flaviviral RNA genomes are composed of discrete RNA structural units arranged in an ordered fashion and grouped into complex folded domains that regulate essential viral functions, e.g. replication and translation. This is achieved by adjusting the overall structure of the RNA genome via the establishment of inter- and intramolecular interactions. Translation regulation is likely the main process controlling flaviviral gene expression. Although the genomic 3′ UTR is a key player in this regulation, little is known about the molecular mechanisms underlying this role. The present work provides evidence for the specific recruitment of the 40S ribosomal subunit by the 3′ UTR of the West Nile virus RNA genome, showing that the joint action of both genomic ends contributes the positioning of the 40S subunit at the 5′ end. The combination of structural mapping techniques revealed specific conformational requirements at the 3′ UTR for 40S binding, involving the highly conserved SL-III, 5′DB, 3′DB and 3′SL elements, all involved in the translation regulation. These results point to the 40S subunit as a bridge to ensure cross-talk between both genomic ends during viral translation and support a link between 40S recruitment by the 3′ UTR and translation control.

Mebendazolium mesylate anhydride salt: rational design based on supramolecular assembly, synthesis, and solid-state characterization.

The design mebendazole (MBZ) multicomponent systems is important to obtain new materials that incorporate the API (active pharmaceutical ingredient) with better thermal stability, avoiding the interconversion of desmotropes. Interestingly, the presence of water molecules in the mebendazolium mesylate monohydrate prevents the formation of the R22(8) supramolecular synthon, found in all mebendazolium salts with polyatomic counterions. Here, we designed a new mebendazolium mesylate anhydrous salt based on statistical scrutiny of all mebendazole crystal structures identified in the literature and an exhaustive analysis of the conformational and geometrical requirements for the supramolecular assembly. The synthesis of this new salt and its solid-state characterization through single-crystal X-ray diffraction and complementary techniques are presented. As expected, mebendazole recrystallization in methanol with methanesulfonic acid - a Food and Drug Administration accepted coformer - in the absence of water yields a mesylate anhydrous salt with 1 : 1 stoichiometry. This new salt crystallizes in the P212121 (19) space group. The main intermolecular interactions found in the crystal structure are the hydrogen bonds that form a R22(8) supramolecular motif that assembles the ionic pairs. Additional non-classical H-bond, as well as π⋯π and carbonyl⋯cation interactions, contribute to the final stabilization of the crystal packing. This new salt is stable up to 205 °C when it undergoes the endothermic loss of the ester moiety to yield 2-amino-5-benzoylbenzimidazole. Moreover, preliminary dissolution experiments in aqueous 0.1 mol L-1 HCl suggest an apparent solubility of mebendazolium mesylate anhydride 2.67 times higher than that of the preferred for pharmaceutical formulations MBZ form C.

Using Inducible Signaling Receptors to Increase Erythropoietic Output from Genome-Edited Hematopoietic Stem Cells

Introduction: Oxygen is delivered to all tissues in the body through the hemoglobin molecule uniquely present in red blood cells (RBCs). Proper production and function of RBCs is therefore critical to human health. However, genetic defects of the hematologic system such as anemias and hemoglobin disorders (broadly termed “hemoglobinopathies”) are among the most common genetic disorders in the world. Therefore, developing strategies to regulate RBC development may allow researchers and clinicians to increase therapeutic potential of hematologic cell and gene therapies. Erythropoietin (EPO) signaling is indispensable to RBC development. In its native form, two EPO receptor (EPOR) monomers dimerize in the presence of EPO cytokine to initiate a downstream signaling cascade. Prior work has shown that conformational requirements of EPOR dimerization are rather “loose” and signaling may also be initiated by agonistic diabodies or in the context of chimeric receptors. While these chimeric receptors have limited clinical applicability, inducible dimerization domains such as engineered FKBPs are currently being used in clinical trials in the form of inducible safety switches. Due to the modular nature of cytokine receptors, we hypothesized that inducible dimerization domains (such as the FKBP domain) could be paired with endogenous receptors and signaling pathways to generate chimeric receptors that place RBC development under the control of a bioavailable small molecule - and therefore in the control researchers and clinicians. This study presents a set of chimeric, synthetic receptors that support HSPC output towards the erythroid lineage via a non-immunogenic, non-toxic small molecule (AP30187, hereafter termed “BB”). Methods: In-vitro editing was performed in primary human CD34+ HSPCs by electroporating Cas9 protein complexed with sgRNA along with an AAV6 DNA repair template to facilitate gene insertion via homology-directed repair (HDR). Bulk edited CD34+ HSPCs were then differentiated into RBCs using established differentiation protocols in the presence and absence of both erythropoietin and BB. Differentiation was determined by staining for RBC surface markers (CD71 and GPA) and subsequent flow cytometry analysis. Erythropoietic output was determined by cell density counts. Allele frequency of the edited cell population was determined through droplet digital PCR. Results: We generated seven FKBP-EPOR chimeric receptors - with the basic structure of SFFV-[FKBP-EPOR]-2A-YFP-bGH - that placed the FKBP binding domain at different regions of the endogenous receptor (Figure 1) and analyzed their ability to support RBC differentiation in the absence of EPO but with BB. Out of the seven constructs we found a set of receptors - 1.4 and 1.5 - that demonstrated erythropoietin-independent, BB-mediated erythroid differentiation at 108% and 94% mock RBC differentiation respectively. Construct 1.5 - dubbed inducible EPOR (iEPOR) - was chosen over 1.4 for further optimization because it was also no longer EPO responsive. We further optimized the design of iEPOR by 1) introducing a secretory signal peptide to improve trafficking of the receptor to the cell surface; 2) inclusion of a naturally occurring EPOR truncation that results in supraphysiological RBC differentiation; and 3) modification of the genomic insertion site and promoter of the iEPOR cassette to generate a toolbox of expression profiles. Our results suggest that iEPOR mimics the native EPOR signaling cascade with high fidelity and sensitivity according to bulk RNA-Seq data. We also observe a significant increase in erythropoietic output for iEPOR version 1.4 (6.7-fold by day 11 of RBC differentiation in +BB over -BB conditions, P=0.003), which was further enhanced by the above modifications for vector iEPOR version 3.5.2 (12.9-fold by day 11 of RBC differentiation in +BB over -BB conditions, P<0.0001). Additionally, iEPOR is demonstrated to be erythropoietin-independent, dose-responsive, and tunable via expression from different loci and promoters. Conclusion:iEPORs represent a powerful new tool to alter the cellular dynamics of red blood cell development. The work demonstrated in this study has the potential to dramatically improve the efficacies of existing gene therapies, offer a route to EPO-free ex-vivo RBC production, as well as serve as a new tool by which to better understand stem cell biology and differentiation.

Co-Design of Approximate Multilayer Perceptron for Ultra-Resource Constrained Printed Circuits

Printed Electronics (PE) exhibits on-demand, extremely low-cost hardware due to its additive manufacturing process, enabling machine learning (ML) applications for domains that feature ultra-low cost, conformity, and non-toxicity requirements that silicon-based systems cannot deliver. Nevertheless, large feature sizes in PE prohibit the realization of complex printed ML circuits. In this work, we present, for the first time, an automated printed-aware software/hardware co-design framework that exploits approximate computing principles to enable ultra-resource constrained printed multilayer perceptrons (MLPs). Our evaluation demonstrates that, compared to the state-of-the-art baseline, our circuits feature on average 6x (5.7x) lower area (power) and less than 1% accuracy loss.

Preserving the positivity of the deformation gradient determinant in intergrid interpolation by combining RBFs and SVD: Application to cardiac electromechanics

The accurate, robust and efficient transfer of the deformation gradient tensor between meshes of different resolution is crucial in cardiac electromechanics simulations. This paper presents a novel method that combines rescaled localized Radial Basis Function (RBF) interpolation with Singular Value Decomposition (SVD) to preserve the positivity of the determinant of the deformation gradient tensor. The method involves decomposing the evaluations of the tensor at the quadrature nodes of the source mesh into rotation matrices and diagonal matrices of singular values; computing the RBF interpolation of the quaternion representation of rotation matrices and the singular value logarithms; reassembling the deformation gradient tensors at quadrature nodes of the destination mesh, to be used in the assembly of the electrophysiology model equations. The proposed method overcomes limitations of existing interpolation methods, including nested intergrid interpolation and RBF interpolation of the displacement field, that may lead to the loss of physical meaningfulness of the mathematical formulation and then to solver failures at the algebraic level, due to negative determinant values. Furthermore, the proposed method enables the transfer of solution variables between finite element spaces of different degrees and shapes and without stringent conformity requirements between different meshes, thus enhancing the flexibility and accuracy of electromechanical simulations. We show numerical results confirming that the proposed method enables the transfer of the deformation gradient tensor, allowing to successfully run simulations in cases where existing methods fail. This work provides an efficient and robust method for the intergrid transfer of the deformation gradient tensor, thus enabling independent tailoring of mesh discretizations to the particular characteristics of the individual physical components concurring to the of the multiphysics model.

Lack of conformity of goods with the contract and sustainability issue – Directive (EU) 2019/771

This paper analyses the provisions of Directive (EU) 2019/771 on certain aspects concerning contracts for the sale of goods from the sustainability perspective. In order to determine whether the legal solutions enshrined in the mentioned Directive represent a novelty, the paper also focuses on the provisions of Directive 1999/44/EC on certain aspects of the sale of consumer goods and associated guarantees. This article aims to assess the contribution of Directive (EU) 2019/771 to achieving more sustainable consumption patterns. The issues covered concern the requirements of conformity, the legal guarantee period, the obligation to provide spare parts, the primary and secondary set of remedies, the commercial guarantee, and the expected future steps toward the amendments to Directive (EU) 2019/771. Although Directive (EU) 2019/771 explicitly mentions achieving more sustainable consumption patterns and a circular economy and encouraging sustainable consumption, it may be stated that these notions are not considered to a sufficient extent. Namely, the right to repair is not prioritised over the right to a replacement, while the obligation to provide spare parts is not included among the objective requirements of conformity. The opportunity granted to the Member States to allow the consumer to opt for a specific remedy if the lack of conformity appears within a period not exceeding 30 days after the delivery may be considered another example of neglecting the mentioned notions.

“When They Hand You Your Uniform, They Forget to Say, ‘Hand Me Your Soul’”: Incidents and Impacts of Institutional Betrayal in Canadian Police Services

ABSTRACT This interdisciplinary study applies Erving Goffman’s sociological theory of the total institution and the psychological framework of institutional betrayal to better understand how ongoing gendered and racialized power structures are maintained in Canadian policing. An intersectional analysis of 116 in-depth interviews with police officers from 31 police services and an on-line, national survey (N = 727) reveal that steep institutional requirements of assimilation and conformity, combined with various, commonly reported mechanisms of institutional betrayal effectively silenced, discredited, and/or minimized reports of sexual and gender and/or race-based workplace abuse. This led to significantly negative impacts on racialized women, men, and white women’s mental health, retention rates, and willingness to report workplace abuse. Overall, this study found the ongoing presence of systemic racism and sexism within police services across Canada, institutional knowledge of their existence, coordinated efforts to contain complaints, and ongoing resistance to meaningful change.

Internal Auditing Risk Analysis for Medical Laboratories Seeking Accreditation through the Hong Kong Laboratory Accreditation Scheme (HOKLAS).

The primary aim of this study was to determine quantitatively the extent of coverage of the Hong Kong Laboratory Accreditation Scheme (HOKLAS 015) requirements by guidance checklists (HOKLAS 016-02 and HOKLAS 021). The level of conformance requirement coverage of HOKLAS 015 by HOKLAS 016-02 and HOKLAS 021 was calculated by an evaluation checklist based on conformance requirements in HOKLAS 015. A distribution analysis of conformance requirements relating to the International Standard ISO 15189:2012 process-based quality management system model was also performed to elicit further coverage information. HOKLAS 016-02 was found to provide coverage of 76% while HOKLAS 021 was found to provide coverage of 11%. HOKLAS 015 was also found to have a distribution coverage of 78% relating to the International Standard ISO 15189:2012 process-based quality management system model. The results of this analysis should be of value to medical laboratories wishing to maintain the internal auditability required by HOKLAS 015 by gaining an awareness of the extent of coverage provided by HOKLAS 016-02 and HOKLAS 021.

Stabilizing hydroperoxyflavin intermediate formation via a peptide appendage: a neutral flavoenzyme model.

A bioinspired mimic for the stabilization of hydroperoxyflavin intermediate formation was designed and investigated for monooxygenase like catalytic properties. A suitable peptide appendage was covalently linked to the C7-position of the neutral isoalloxazine core to synthesize Fl-G, Fl-F, Fl-P, and Fl-βA analogues. While the presence and identity of the peptide appendage were found to be crucial for catalytic efficiency, corroborative observations were made from theoretical studies as well, supporting the precise conformational and accessibility requirements for the stabilization of the key hydroperoxyflavin intermediate. A simple yet elegant flavopeptide model (Fl-G) was found to achieve almost quantitative catalytic efficiency compared to the control flavin analogue without a peptide appendage.

KEC 기준을 적용한 저압 전기설비의 접지저항값에 따른 접지계통 안전성 분석

The KEC(Korea Electro-technical Code) is applied in accordance with the international standard conformity requirement for installation and inspection of domestic electrical equipments. The main differences between KEC and the past standard are classification of grounding methods according to the type of grounding system, and protection against electric shock. Accordingly, in the standard of human body protection from electric shock, the allowable dangerous voltage has become more important than the grounding resistance value, but in the case of design and construction of low voltage electrical equipment, it is difficult to calculate that. Therefore, in this paper we model the types of grounding systems that can be applied in Korea through simulation, and the safety of the grounding system according to the grounding resistance value in terms of electric shock protection is reviewed by simulating human electric shock case study.

Practical considerations for laboratories: Implementing a holistic quality management system.

A laboratory quality management system (LQMS) is an essential element for the effective operation of research, clinical, testing, or production/manufacturing laboratories. As technology continues to rapidly advance and new challenges arise, laboratories worldwide have responded with innovation and process changes to meet the continued demand. It is critical for laboratories to maintain a robust LQMS that accommodates laboratory activities (e.g., basic and applied research; regulatory, clinical, or proficiency testing), records management, and a path for continuous improvement to ensure that results and data are reliable, accurate, timely, and reproducible. A robust, suitable LQMS provides a framework to address gaps and risks throughout the laboratory path of workflow that could potentially lead to a critical error, thus compromising the integrity and credibility of the institution. While there are many LQMS frameworks (e.g., a model such as a consensus standard, guideline, or regulation) that may apply, ensuring that the appropriate framework is adopted based on the type of work performed and that key implementation steps are taken is important for the long-term success of the LQMS and for the advancement of science. Ultimately, it ensures accurate results, efficient operations, and increased credibility, enabling protection of public health and safety. Herein, we explore LQMS framework options for each identified laboratory category and discuss prerequisite considerations for implementation. An analysis of frameworks' principles and conformity requirements demonstrates the extent to which they address basic components of effective laboratory operations and guides optimal implementation to yield a holistic, sustainable framework that addresses the laboratory's needs and the type of work being performed.

Optimizing safety budget allocation in process industry using risk metrics

Pro-active investment into process risk mitigation can impact organizational business performance positively by allowing avoidance of future accidents. While several approaches have been reported in the literature, there is a need for a plant-wide safety investment optimization (SIO) framework in order to mitigate all identified, credible accident scenarios. The present work includes both individual and societal risk as metrics simultaneously for decision-making for optimal risk reduction. The overall framework satisfies three requirements: ensuring compliance with national process risk acceptance regulations; procurement of insurance cover for specific risks, and investment in selective residual risks, not attended to in the previous phases, so as to secure financial benefits of reduced asset and human losses from possible future accidents. An example case study based on a process plant is presented in way of illustrating the application of the SIO framework. The first layer of quantitative risk analysis computations indicates the public IR exceeds the tolerable limit, but societal risk (SR) compliance exists. The algorithm to enable compliance for SR by mitigating the maximum cumulative accident frequency and/or fatality is presented. Next, based on expected annualized loss, we illustrate the choice of an insurance cover for mitigating the residual risks that may cause significant property losses. Thereafter, based on the availability of additional safety budget, a cost-benefit analysis for safeguards for mitigating the still remaining risks is exemplified. This leads to the identification of the combination of safeguards that secure the maximum possible benefit to the organization. This step, in effect, allows the organization to progress beyond the minimal requirement of regulatory conformity. The cost-benefit analysis demonstrated can potentially constitute a viable business decision as it may allow an organization to secure the best return on focused investments on safeguards.

Neutralizing antibodies protect mice against Venezuelan equine encephalitis virus aerosol challenge.

Venezuelan equine encephalitis virus (VEEV) remains a risk for epidemic emergence or use as an aerosolized bioweapon. To develop possible countermeasures, we isolated VEEV-specific neutralizing monoclonal antibodies (mAbs) from mice and a human immunized with attenuated VEEV strains. Functional assays and epitope mapping established that potently inhibitory anti-VEEV mAbs bind distinct antigenic sites in the A or B domains of the E2 glycoprotein and block multiple steps in the viral replication cycle including attachment, fusion, and egress. A 3.2-Å cryo-electron microscopy reconstruction of VEEV virus-like particles bound by a human Fab suggests that antibody engagement of the B domain may result in cross-linking of neighboring spikes to prevent conformational requirements for viral fusion. Prophylaxis or postexposure therapy with these mAbs protected mice against lethal aerosol challenge with VEEV. Our study defines functional and structural mechanisms of mAb protection and suggests that multiple antigenic determinants on VEEV can be targeted for vaccine or antibody-based therapeutic development.

Managing enterprise information: meeting performance and conformance objectives in a changing information environment

This paper presents the findings of an in-depth survey to examine the current status of enterprise information management (EIM) in organizations. The survey explores five key areas: drivers and capabilities of EIM; current status of EIM strategies; EIM content and technologies; EIM and compliance; and the changing role of the information professional. The survey reveals that the drivers for EIM cannot be simply reduced to a series of technical or organizational needs and that EIM is a complex sociotechnical phenomenon. A fine balance is required to achieve business performance objectives whilst at the same time also meeting conformance requirements. To date, few organizations have implemented enterprise-wide EIM strategies; however those who do have them are better able to keep track of, and achieve, performance objectives. In terms of technologies and content the landscape is complex with organizations focusing their efforts into managing and reducing this complexity. Finally information management work is changing; the survey reveals EIM as a multi-stakeholder activity requiring the combination of a wide range of professional groups, skills and knowledge. The survey findings provide the basis for further research investigations in supporting organization in their EIM initiatives.

Conformity Evaluation of Afinion 2 Analyzer Maintainability: Compliance Practicality for Philippine National Standard PNS ISO 15189:2013 Accreditation.

The implementation of Philippine National Standard PNS ISO 15189:2013 to support the medical laboratory to produce competent results is a recognised challenge. It is apparent that the approach of ensuring the equipment availability can be specifically optimised. No known research has focused on exploring on the conduct of conformity evaluation of Afinion 2 Analyzer maintainability for the PNS ISO 15189:2013 accredited medical laboratory. The aim of the current study was to develop a practical tool for the medical laboratory to support the internal audit process by determining the compliance status of Afinion 2 Analyzer maintainability. The relevant conformance requirements in Clauses 4 (Management requirements) and 5 (Technical requirements) of PNS ISO 15189:2013, manufacturer requirements and specific requirements for accreditation from 70/101 (69%) accreditation bodies in 80/249 (32%) countries were identified as specific audit criteria for Afinion 2 Analyzer conformity evaluation checklists for the maintenance and reference equipment. This study identified a total of 44/1515 (2.9%) conformance requirements and 33/1515 (2.2%) conformance requirements was associated with the hardware and software component of Afinion 2 Analyzer, respectively in Clauses 4 and 5 of PNS ISO 15189:2013. In addition, manufacturer requirements (n = 5) were identified relating to preventive maintenance. Further, specific requirements for accreditation for maintenance of reference equipment were identified and selected from 13/75 (17%) accreditation bodies in 26/90 (29%) countries; together these requirements were used to develop conformity evaluation of Afinion 2 Analyzer checklists (n = 3) and an interpretation checklist. The present study has offered a practical contribution to existing knowledge of PNS ISO 15189:2013 accreditation compliance management by providing the medical laboratory with a practicable tool to determine the conformity status of Afinion 2 Analyzer maintainability in accordance with PNS ISO 15189:2013 conformance requirements, manufacturer and specific requirements for accreditation.

Finite-amplitude acoustic responses of large-amplitude vibration objects with complex geometries in an infinite fluid

High-intensity acoustic waves existing commonly in aeronautical and aerospace vehicles manifest nonlinear propagation behaviors. Large-amplitude vibration and irregular shape of the aerospace vehicles further complicate the acoustic responses. This paper is concerned with numerical analysis of finite-amplitude acoustic responses of complex-shaped vibration objects. The time-dependent effect of the solid boundary position due to the large-amplitude vibration of the objects is considered. A set of first-order differential equations is derived to govern the finite-amplitude acoustic wave. A fourth-order dispersion-relation-preserving finite difference formulation is employed to solve the nonlinear acoustic equations on a fixed Cartesian grid. Acoustic responses of the fluid and the vibration of the complex-shaped object are coupled by considering the compatibility conditions on the fluid-solid interface. A ghost-cell sharp-interface immersed boundary method is utilized to relax the conformity requirement between the computational grid and solid boundary. Numerical filters are employed in the computational procedure to suppress numerical oscillations. The present method is validated through several numerical tests. Numerical analysis of finite-amplitude acoustic responses of a complex-shaped object is performed. The nonlinear effect of a finite-amplitude acoustic wave, the time-dependent effect of solid boundary position, and the coupling effect between them on the propagation behaviors of nonlinear acoustic waves are discussed.