International Organization For Standardization Research Articles

Clinical Application of ISO and CEN/TS Standards for Liquid Biopsies-Information Everybody Wants but Nobody Wants to Pay For.

Liquid biopsies are emerging as valuable clinical biomarkers for cancer monitoring. Although International Organization for Standards (ISO) and Technical Specifications from the European Committee for Standardization (CEN/TS) standardized workflows exist, their implementation in clinical practice is underdeveloped. We aimed to assess the applicability of ISO and CEN/TS standards in a real-world clinical setting, with a particular focus on evaluating the impact of preanalytical parameters and hemolysis on liquid biopsy analysis. We evaluated 659 peripheral blood samples from advanced prostate cancer patients against ISO and CEN/TS standards and documented all essential criteria, including tube draw order, filling level, temperature, and time tracking from blood draw to storage. We assessed hemolysis and its effect on circulating tumor DNA (ctDNA) and circulating tumor cell (CTC) analysis. Our results demonstrated a high compliance rate, with 96.2% (634/659) of samples meeting essential ISO and CEN/TS criteria. We did not observe a significant impact on ctDNA or CTC detection rates between hemolytic and nonhemolytic samples. Hemolysis was identified in 12.9% (40/311) of plasma samples from our advanced prostate cancer cohort, and within the draw order of 5 blood collection tubes, hemolysis did not significantly increase from tube 1 to 5. In total, 83.8% (552/659) of blood collection tubes had high fill levels above 80% of nominal filling level. Our study demonstrates the feasibility and benefits of adhering to ISO and CEN/TS standards in a clinical liquid biopsy study. The standards revealed that hemolysis occurred frequently but did not impair downstream ctDNA and CTC analysis in our cohort of advanced prostate cancer patients.

Free Radicals in Little Cigar Mainstream Smoke and the Potential Influence of Flavoring Chemicals on Free Radical Production.

Implementation of the Tobacco Control Act in 2009 banned characterizing flavors in cigarettes (except menthol and tobacco), but substitution has occurred by the continued availability of alternative flavored products (i.e., flavored little cigars). Little is known about how flavorants in noncigarette tobacco products impact human health. Thus, we investigated the impact of flavorants on free radical production in the mainstream smoke of little cigars. Gas- and particulate-phase free radical yields in mainstream smoke generated from 12 commercial little cigar brands and research little cigars and cigarettes were measured via electron paramagnetic resonance spectroscopy using the International Organization of Standardization (ISO) smoking protocol. Flavorants were extracted from unsmoked little cigars and analyzed by gas chromatography-mass spectroscopy. Gas- and particulate-phase radical yields from little cigars ranged from 13.5 to 97.6 and 0.453-1.175 nmol/unit, respectively. Comparatively, research cigarettes yielded an average of 4.9 nmol gas-phase radicals/unit and 0.292 nmol particulate-phase radicals/unit. From the products, 66 flavorants were identified, with each brand containing 4-24 individual flavorants. The free radical content was strongly correlated with the number of flavorants present in each cigar (r = 0.74, p = 0.01), indicating that highly flavored little cigars may produce higher levels of toxic free radicals. The presence of the flavorant ethyl methylphenylglycidate (strawberry) was associated with >2-fold higher levels of GP radicals (p = 0.001). Our results show that free radical delivery from little cigars is greater than that from research cigarettes and provide empirical evidence for the harmfulness of flavored tobacco products. Additionally, it demonstrates that flavorants present in combustible tobacco products can influence the levels of free radicals produced. Therefore, future tobacco product standards should consider little cigars.

Validation of two automatic sphygmomanometers according to the modified International Standardization Organization 81060-2:2018 protocol in adults with a mid-upper arm circumference of 22 centimeters or less.

A recent International Organization for Standardization (ISO) Task Group report calls for research to investingate potential special populations in validation studies of automated blood pressure (BP) devices. Accordingly, we aimed to determine the accuracy of two previously validated BP monitors passed in a general population when measured in adults with a mid-upper arm circumference (MUAC) ≤ 22 cm. Test device A was the OMRON HEM 7121 equipped with the HEM CS24 cuff designed for an arm circumference of 17-22 cm. Test device B was the YuWell YE660Е with the YuWell '360°' cuff (18-36 cm). Data from 37 participants aged 20.14 ± 2.23 (18-28) years were analyzed according to criterion 1 of ISO Standard 81060-2 : 2018. According to criterion 1, the mean ± SD of the BP differences for the device A was -7.81 ± 5.20/-10.66 ± 5.48 mmHg (systolic/diastolic) and for the device B was -8.00 ± 6.30/-16.11 ± 5.15 mmHg (systolic/diastolic), respectively. This means that neither device met the requirements. Since devices A and B, which had passed in a general population study, failed in adults aged 18-28 years with an MUAC ≤ 22 cm, such individuals might be considered as new special population for validation studies.

Validating the Accuracy of Omron HEM-1026 (HCR-1901T2/HCR-1902T2): Blood Pressure Monitoring Device at Home, According to the Universal Protocol.

The performance of Omron HEM-1026 (HCR-1901T2 / HCR-1902T2) for monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018+amendment (Amd)1:2020 protocol. The device was assessed in 101 participants who fulfilled the inclusion criteria, including arm circumference range and systolic and diastolic BP provided by the protocol. Data validation and analysis were performed according to the manufacturer's instructions. In the ISO 81060-2:2018+Amd 1:2020 validation procedure (criterion 1), the mean ± standard deviation (SD) of the differences between the test device and reference BP was -2.1 ± 7.24/-0.6 ± 5.63 mmHg (systolic/diastolic). These data fulfilled the ISO81060-2:2018+Amd1:2020 requirement of ≤5±≤8 mmHg. The mean differences between the two observers and Omron HEM-1026 were -2.1 ± 5.71 mmHg for systolic BP and -0.6 ± 4.81 mmHg for diastolic BP, fulfilling criterion 2 with an SD of ≤ 6.62 for systolic BP and ≤ 6.91 for diastolic BP. The two ISO criteria were fulfilled. The Omron HEM-1026 BP monitor fulfilled the requirements of the ISO 81060-2:2018+Amd 1:2020 validation standard and can be recommended for home BP measurements in the general population.

Implementation of energy reduced 90Sr/90Y radiation fields, or: Propagation of beta radiation, a case study

Reference beta-particle radiation fields are well described in the standard series ISO 6980 issued by the International Organization for Standardization (ISO). In its 2022/2023 edition, two new radiation fields are defined consisting of a radioactive 90Sr/90Y source and a 3 mm or 4 mm plastic absorber located 4 cm in front of the source — with the reference plane of the radiation field being located 20 cm from the source. In this work, the detailed method of how to implement and use these new radiation fields using a Beta Secondary Standard, BSS 2, is described. Furthermore, the influence of the position and thickness of the plastic absorber on the radiation field, i.e., on its spectral and angular distribution as well as on the dose rate, was investigated. It turned out that a change of position by one centimeter or a thickness change of a tenth of a millimeter result in significant changes of the dose rate (∼ 7 % to ∼ 10 %). Finally, the dependence of the angular and spectral distribution on the position and thickness of the absorber was investigated in detail.

3D-printed Ti6Al4V thoracic fusion cage: Biomechanical behavior and strengthening mechanism

To effectively replace diseased and damaged thoracic vertebrae, a series of three-dimensional (3D) printed titanium (Ti) alloy (Ti6Al4V) thoracic fusion cages with varying volume ratio of reinforced scaffolds are designed, and their structure-function relationships are investigated systematically. It is demonstrated that the mechanical strength of fusion cage is gradually enhanced as the scaffold volume increases, which may be attributed to its textural transformation from α phase to β phase. The compressive, shear, and fatigue of fusion cages successfully attain the International Organization for Standardization (ISO 23089), when the scaffold volume ratio exceeds 15%. Furthermore, the biomechanical analyses, including stress distributions and subsidence in flexion, extension, axial rotation, and lateral bending sections of fusion cages, further shed light on their potential clinical applications. This work deeply deciphers the intrinsic connection between biomechanical property and material texture of the thoracic fusion cages, offering valuable insights into their strengthening mechanism, which providing a guidance for the precise design and quick synthesis of other 3D-printed Ti6Al4V implants.

Acciones para establecer el esquema de certificación de Sistemas de Gestión de Organizaciones Educativas basado en NC-ISO 21001:2019 en Cuba

To demonstrate their quality, higher education institutions can be accredited by sectoral educational quality schemes or certify their management systems, following the approaches of the International Organization for Standardization. The objective of this work is to present the actions carried out in Cuba to establish the certification scheme, according to NC-ISO 21001:2019. To this end, a descriptive research was carried out, with a qualitative approach, supported by the analysis of scientific articles and other documents that substantiate the importance of the SGOE. The focus group technique was applied to know the experts' perceptions about the relevance of establishing this certification in the country. The necessary actions were planned to establish the scheme and it was designed with the University of Havana, as owner. The certification of Management Systems for Educational Organizations will allow institutions that provide higher-level and postgraduate training services to demonstrate the quality of their educational processes, through compliance with the NC-ISO 21001:2019 standard, by a third-party evaluation scheme, which includes educational organizations that are not governed by the sectoral accreditation system established in Cuba.

Enrollment Appraisal Using Rule-Based Decision Support System

This study explores the development and evaluation of a web-based enrollment appraisal system utilizing a rule-based decision support system for universities and colleges. Designed for the context of Antique, Philippines, the system leverages a two-tier architecture for efficient processing and secure data management. A user-friendly interface guides applicants through the enrollment process, while a secure server and rule-based engine analyze data against pre-defined eligibility criteria. The Rapid Application Development (RAD) methodology ensured a user-centered design with iterative development cycles incorporating user feedback. Evaluations using McCall's Software Quality Standard and the International Organization for Standardization and International Electrotechnical Commission (ISO/IEC) 25010 standard revealed the system's strengths in technical aspects (security, usability) and overall functionality. User feedback highlighted areas for improvement in interface design, clarity, and user perceptions of data security. The study concludes that the system offers a promising approach for more efficient and transparent enrollment processes. By addressing the feedback received, the system can be further enhanced to improve the user experience and build trust among applicants.

Evaluating the impact of safety pictogram training on comprehension scores and knowledge retention among engineering students

Safety pictograms are essential tools for identifying workplace hazards by providing critical information about health hazard risks, fire safety, emergency evacuation, and accident prevention. Effective safety pictogram training programs are necessary to enhance workers' knowledge of these pictograms. This study evaluates the effectiveness of a safety pictogram training program on the comprehension and retention of knowledge among engineering students. A total of 262 participants were asked to predict the meaning of 22 safety pictograms regulated by International Organization for Standardization (ISO) 7010 before and after a one-hour online training session. A follow-up test was administered six months later to assess long-term knowledge retention. Results showed that the average comprehension rate increased from 60.1 % before training to 68.3 % after training, with a retention rate of 66.0 % six months after training. The study found that training positively affected comprehension of emergency and mandatory action pictograms, while lower scores were observed for warning pictograms. Statistical tests revealed a significant effect of training on comprehension levels 16 out of 22 pictograms, with an average increase in comprehension of 11.2 %. Of these 16 pictograms, the comprehension level of 10 pictograms increased after training and remained at the same level six months later. However, the scores decreased slightly six months after the intervention, indicating the need for continued reinforcement or retraining. These findings have important implications for safety education and training programs, particularly in industries where safety hazards are widespread. The positive impact of training on comprehension scores highlights the ongoing need to improve safety pictogram comprehension to consistently meet standard acceptance criteria. Future training programs may need to focus on categories such as warning pictograms and fire equipment and fire action pictograms, which exhibited lower comprehension scores, to ensure better employee understanding.

Effects of Testing Methods and Sample Configuration on the Flexural Properties of Extruded Polystyrene.

Extruded polystyrene (XPS) is frequently used in the construction of many different structures. Therefore, it is necessary to appropriately characterize its mechanical properties to ensure the safety of said structures. Among the available characterization tests, static bending tests are simple and easy to perform; owing to these characteristics, they should be performed more frequently than other tests. In static bending tests on XPS, there are several challenges owing to the high flexibility of XPS, and the chosen testing method and sample configuration affect the accuracy of characterization. For cellular plastics, including XPS, three-point bending (TPB) test methods are standardized by the International Organization for Standardization (ISO) and Japanese Industrial Standards (JIS) as in ISO 1209-2:2007 and JIS K 7221-2:2006, respectively, where the sample configurations are determined. Therefore, TPB tests of cellular plastics have been conventionally performed based on these standardized methods to characterize the bending properties. In contrast, investigations on the effects of testing methods and sample configurations have often been neglected due to the existence of these standardized methods. However, to characterize the bending properties of XPS accurately, the effects of the testing method and sample configuration must be examined in detail. In this study, three bending properties (Young's modulus, proportional limit stress, and bending strength) of samples cut from an XPS panel were determined using three-point bending (TPB), four-point bending (FPB), and compression bending (CB) tests with varying sample span/depth ratios from 5 to 50 at intervals of 5, and statistical analyses were performed to determine the relevance of the tests. The effect of sample configuration on Young's modulus could be reduced when the span/depth ratio range was 25-50, 25-50, and 15-50 in the TPB, FPB, and CB tests, respectively, whereas that on the proportional limit stress was reduced in the span/depth ratio range of 5-50, 20-50, and 15-50 in the TPB, FPB, and CB tests, respectively. Additionally, the effect on the bending strength was reduced when the span/depth ratio range was 5-50, 20-50, and 5-50 in the TPB, FPB, and CB tests, respectively. Therefore, these results suggest that the TPB and CB tests were more feasible than the FPB test when the span/depth ratio was determined as being 25-50 and 15-50, respectively. However, clear differences were observed in the sample bending properties determined in these tests. In light of these findings, further studies should be conducted to elucidate these differences.

Investigation of prevalence and antimicrobial resistance of Salmonella in pet dogs and cats in Turkey.

Although salmonellosis is considered to be a foodborne zoonotic disease, pets can play a significant role in the dissemination of antimicrobial-resistant Salmonella organisms to humans because of close contact with their owners. To determine the prevalence, risk factors, virulence factors, serotypes, and antimicrobial resistance profile of Salmonella in pet dogs and cats in Turkey and to assess the public health risk. Furthermore, to perform macroscopic comparison of lactic acid bacteria (LAB) in Salmonella-positive and Salmonella-negative animals. International Standards Organization (ISO) 6579-1:2017 and Food and Drug Administration (FDA) methods were used to compare the effectiveness of culture methods in the identification of Salmonella in 348 rectal swabs. Positive isolates were serotyped using the slide agglutination method according to the White-Kauffmann-Le Minor scheme and the presence of virulence genes (invA and stn) were evaluated by polymerase chain reaction (PCR). Antimicrobial activity was tested by Kirby-Bauer disk diffusion method according to Clinical and Laboratory Standards Institute (CLSI) guidelines. Salmonella prevalence was 5.73% (9/157) in dogs and 0.0% (0/191) in cats. Eight (8/9) isolates were cultured with the ISO method and 5 (5/9) isolates were cultured with the FDA method. Macroscopic results revealed that Salmonella agents had no effect on LAB. Three different serotypes were detected and all isolates were positive for virulence genes. Antibiotic resistance profiling indicated that 11.1% of the isolates were MDR and the highest resistance was found for ciprofloxacin. MDR-resistant S. Virchow and carbapenem-resistant S. Enteritidis were detected from dog isolates. There was a significant difference between raw meat consumption and Salmonella carriage (p < 0.01). Dogs could be potential carriers of Salmonella infection. The isolation of Salmonella in healthy dogs instead of dogs suffering from diarrhoea indicates that attention should be paid to asymptomatic carriage. The emergence of resistance among zoonotic Salmonella isolates poses a significant threat to public health.

Establishing a Geo-Database for Drinking Water and Its Delivery and Storage Components with an Object-Based Approach

Infrastructure facilities that serve the city as a whole and should be considered as a whole should be built in an orderly and planned manner, just as cities are. Infrastructure facilities become obsolete over time. Aging infrastructure facilities may become unserviceable over time. When the need for maintenance and repair arises, it is mandatory to renew or replace infrastructure facilities. In this case, necessary maintenance/repair and renovation works should be completed as soon as possible. These infrastructure facilities may not be transferred to maps in the digital environment and may often be managed with person-oriented information, not institutional. There is a problem for decision makers, namely, that the construction, maintenance, repair and governance of infrastructure facilities cannot be carried out systematically, on time and effectively. The only way to provide such a service is through the combined use of today’s informatics, Geographical Information System (GIS) and Global Navigation Satellite System (GNSS) technologies, unlike the classical methods of the past. The aim of the study is to effectively manage the scarce resource of drinking water and its facilities, which are an important component of infrastructure facilities, with a method that uses current mapping technologies and informatics facilities. Especially after Infrastructure for Spatial Information (INSPIRE) and the transformation of Land Administration Domain Model (LADM) to the International Organization for Standardization (ISO) standard, Turkish National Geographic Information System (TNGIS) studies and many academic studies carried out in Türkiye have been modelled with Unified Modelling Language (UML) diagrams in accordance with LADM. Similarly, within the scope of this study, UML diagrams were prepared, and then a GIS database was established. Thanks to field workers, chiefs, engineers and others working on water pipelines, all necessary data, classic, as-built and digital, were gathered. These were collected in different ways in order to conduct spatial and non-spatial analysis in the study area of Trabzon. The most important result from the study is that the entire drinking water infrastructure of Trabzon has been transferred to the system in a structure that allows spatial queries, ensuring that damage detection on water components, maintenance and repair processes are carried out in the shortest time and at the lowest cost. The investigation and application of a sensor-integrated GIS-aided system, making it possible to control and monitor the use of lost and illegal water to be controlled as well as inform consumers who will be affected by possible maintenance and repair, is recommended.

Cyanogenic Glucoside and Methaemoglobin Complex Effects Oo Parboiled Aad Roasted Irish Potato (Solanum Tuberosum) Tubers

The importance of Irish Potatoes (Solanum tuberosum) as a global crop that can be transformed into many products impacting several health dimensions cannot be over emphasized. This research determined the cyanogenic glucosides of raw, parboiled and roasted Irish potatoes (Solanum tuberosum); and the pH effects on the cyanogenic glucosides of the processed Irish potato using a colorimeter through the formation of cyanomethemoglobin. The results show a variation in the cyanogenic glucoside concentration at various pHs. The highest cyanogenic glucoside concentration of 1.18 ± 0.2316 mg/kg was recorded in raw potatoes at pH 8.6 while the lowest cyanogenic glucoside concentration of 1.05 ± 0.0600 mg/ kg was recorded in parboiled Irish potato at pH of 8.6 For processed samples of Solanum tuberosum with Methaemoglobin complex; roasted Irish potatoes has the highest value of cyanide concentration of 1.12 ± 0.0289 mg/kg at pH of 8.6, followed by parboiled potatoes at 1.05 ± 0.0600 mg/kg at pH of 8.6. The highest mean cyanide concentration (0.83 mg/kg) was recorded at pH 8.6 (basic medium) while the lowest mean cyanide concentration (0.74 mg/kg) was recorded at pH 5.8 (acidic medium). The values obtained for the various methods used in processing Irish potatoes were in tandem with recommended standard by World Health Organization (WHO) and International Standard Organization (ISO). The values are lower than the maximum accepted standard of 10 mg of HCN /10 kg body weights. This research summarizes critical information on nutritional profiles of Irish potatoes and their processed products and describes the state of the science relative to the influence of in-home and common commercial processing on nutritional quality and potential impacts on human health.

Accuracy evaluation of Roche Accu‐Chek Performa blood glucose meters at low glucose concentrations: A nine‐year retrospective study

AbstractObjectiveTo evaluate the accuracy of Roche Accu‐Chek Performa glucose meters at a low glucose concentration of &lt;5.55 mmol/L (100 mg/dL) over a 9‐year period.MethodsThe accuracy of the Roche Accu‐Chek Performa glucose meters at low glucose concentrations was evaluated using annual comparison data for 9 consecutive years from 2015 to 2023, according to the acceptability criteria specified in International Organization for Standardization (ISO) 15197:2013. Blood samples with low glucose concentrations of &lt;5.55 mmol/L were prepared by incubation and glycolysis. The glucose concentration was detected using Roche Accu‐Chek Performa glucose meters and a biochemical analyzer in the central laboratory.ResultsA total of 2978 pairs of comparison results from 211 glucose meters at a low glucose concentration of &lt;5.55 mmol/L were retrospectively analyzed from 2015 to 2023. The clinical use duration spanned from 1 to 9 years and 40.76% (86 out of 211 glucose meters) had been used for more than 2 years. The correlation coefficient r between glucose meter measurements and laboratory reference values was 0.98 (p &lt; 0.001). The mean according to Roche Accu‐Chek Performa glucose meters was 0.05 mmol/L (0.9 mg/dL) higher than that of the biochemical analyzer (Z = −13.82, p &lt; 0.0001). The results showed that 100.00% (211 out of 211) of the Roche Accu‐Chek Performa glucose meters met the acceptability criteria specified in ISO 15197:2013. At a low glucose concentration of &lt;5.55 mmol/L, 99.90% (2975 out of 2978) of the comparative data pairs in the error distribution fell within the range of ±0.83 mmol/L (15 mg/dL). Parkes consensus error grid analysis showed that 100.00% (2978 out of 2978) of comparative data pairs fell within region A.ConclusionsThis study demonstrated that Roche Accu‐Chek Performa glucose meters successfully met the accuracy standards of ISO 15197:2013 for measuring blood glucose within the hypoglycemic range. Greater attention should be given to the performance of blood glucose monitoring systems in the low glycemic range, especially for patients with diabetes who are prone to hypoglycemia and require precise measurements.

ANALISIS KUALITAS PADA SISTEM INFORMASI PEMINJAMAN DAN PENGEMBALIAN BARANG MILIK NEGARA POLITEKNIK NEGERI SUBANG

Subang State Polytechnic State Polytechnic Borrowing and Returning Information System (SIP2 BMN POLSUB) isa website-based information system that is used to provide services for borrowing and returning state property(BMN) to the entire academic community of Subang State Polytechnic (POLSUB). The results of information systemdevelopment certainly still have errors and deficiencies, so testing is needed so that the quality of the informationsystem that has been built can be known. To measure the quality of information, a standard is needed that can be used as the basis for whether the information system is feasible or not to be used. Quality assessment in this study uses the International Organization for Standardization (ISO) 9126 standard with six aspects namely functionality,reliability, usability, efficiency, maintainability and portability. The results of the study show that SIP2 BMNPOLSUB has met ISO 9126 standards on the aspects of functionality, usability, efficiency, reliability, portability, and maintainability. Tests were carried out on the POLSUB academic community with data collection techniquesusing a questionnaire. The first aspect is functionality with a value of 100% which shows all the functionality in the system according to user needs. The usability aspect is worth 90% which is where the information system is easy touse. Based on the results from GTMetrix, the efficiency aspect produces grade B with 80% performance and 85%structure, which means that the information system can maintain its performance level. In the reliability aspect, the percentage is 99% which indicates that the information system can be accessed by users at one time, as well as in the portability aspect, it reaches 100%, which means that SIP2 BMN POLSUB can be used by various types ofbrowsers. The last aspect, namely maintainability, reaches 100% and meets the three criteria, namelyinstrumentation, consistency, and simplicity. The final conclusion is that SIP2 BMN POLSUB is suitable for use in POLSUB.

Numerical Simulations of Passive Heat Removal from Mobile Microreactors

As nuclear energy becomes increasingly vital to the goals of carbon neutrality by 2050, nuclear microreactors are being researched as an option for easily transportable energy. Designed to be transportable, factory fabricated, and self-adjusting, nuclear microreactors will fill in the gaps to help make the U.S. power grid more robust. Before designs can proceed, studies must be conducted on the safety of transporting these mobile microreactors while confined within a standard International Organization for Standardization (ISO) shipping container. Because of their mobile nature, microreactors will not have access to many of the engineered decay heat removal methods that traditional reactors utilize during shutdown. Current regulations state that the surface temperature of the microreactor needs to remain below 85°C while being transported on highways. This work investigates the surface temperature profiles of a mobile microreactor while confined within an ISO shipping container that does not allow forced convection to cool the outer reactor wall. Investigations have been performed for several configurations, including different reactor sizes, power levels, and scenarios with or without shielding around the reactor pressure vessel. This conservative safety analysis restricts the power level of the reactor to be less than 1 MW(electric). A more realistic analysis with the intermittent shutdown of shipping container air circulation demonstrates that a 4-MW(electric) reactor will reach 85°C per the Code of Federal Regulations limitations after 1 h.

Approaches for the production of reference materials with qualitative properties—The new International Standard ISO 33406

The number of reference materials (RMs), including certified reference materials (CRMs) characterized for qualitative properties, has steadily increased in recent years. In response, the Technical Committee for Reference Materials of the International Organization for Standardization, ISO/TC 334, developed ISO 33406 to provide guidance to reference material producers (RMPs) on producing qualitative RMs. ISO 33406 builds on the general requirements in ISO 17034:2016 for RMP competence and offers specific guidance on value assignment, assessment of homogeneity and stability, statement of metrological traceability, and measurement uncertainty evaluation for RMs with qualitative property values.

Advancements in 3D Printing: Directed Energy Deposition Techniques, Defect Analysis, and Quality Monitoring

This paper provides a comprehensive analysis of recent advancements in additive manufacturing, a transformative approach to industrial production that allows for the layer-by-layer construction of complex parts directly from digital models. Focusing specifically on Directed Energy Deposition, it begins by clarifying the fundamental principles of metal additive manufacturing as defined by International Organization of Standardization and American Society for Testing and Materials standards, with an emphasis on laser- and powder-based methods that are pivotal to Directed Energy Deposition. It explores the critical process mechanisms that can lead to defect formation in the manufactured parts, offering in-depth insights into the factors that influence these outcomes. Additionally, the unique mechanisms of defect formation inherent to Directed Energy Deposition are examined in detail. The review also covers the current landscape of process evaluation and non-destructive testing methods essential for quality assurance, including both traditional and contemporary in situ monitoring techniques, with a particular focus given to advanced machine-vision-based methods for geometric analysis. Furthermore, the integration of process monitoring, multiphysics simulation models, and data analytics is discussed, charting a forward-looking roadmap for the development of Digital Twins in Laser–Powder-based Directed Energy Deposition. Finally, this review highlights critical research gaps and proposes directions for future research to enhance the accuracy and efficiency of Directed Energy Deposition systems.

The ISO 14001 standard's effect on agrifood small‐ and medium‐sized enterprises' performance: Literature review and empirical evidence

AbstractA significant part of the literature postulates the importance of economic factors and, in particular, market pressure as the main motivation for the adoption of environmental management systems, such as ISO 14001 (International Organization for Standardization). Most of these studies are based on questionnaire surveys assessing the perceptions or opinions of company managers. Few studies have investigated the relationship between the adoption of the standard and economic and financial performance using objective accounting data. This study aimed to test the link between ISO 14001 adoption and economic and financial performance using accounting data from 374 agrifood small‐ and medium‐sized enterprises (SMEs) in Spain during the period 2013 to 2015. The results showed that ISO 14001 contributes to improved commercial and marketing performance through a positive effect on turnover in domestic markets and especially in export markets. However, no positive relationship could be found between ISO14001 and company results or profits. Therefore, ISO 14001 can be considered more as a means of entering and developing sales, particularly in export markets, than a tool to enhance financial profits.

Performance of a Wearable Ring in Controlled Hypoxia: A Prospective Observational Study.

Over recent years, technological advances in wearables have allowed for continuous home monitoring of heart rate and oxygen saturation. These devices have primarily been used for sports and general wellness and may not be suitable for medical decision-making, especially in saturations below 90% and in patients with dark skin color. Wearable clinical-grade saturation of peripheral oxygen (SpO2) monitoring can be of great value to patients with chronic diseases, enabling them and their clinicians to better manage their condition with reliable real-time and trend data. This study aimed to determine the SpO2 accuracy of a wearable ring pulse oximeter compared with arterial oxygen saturation (SaO2) in a controlled hypoxia study based on the International Organization for Standardization (ISO) 80601-2-61:2019 standard over the range of 70%-100% SaO2 in volunteers with a broad range of skin color (Fitzpatrick I to VI) during nonmotion conditions. In parallel, accuracy was compared with a calibrated clinical-grade reference pulse oximeter (Masimo Radical-7). Acceptable medical device accuracy was defined as a maximum of 4% root mean square error (RMSE) per the ISO 80601-2-61 standard and a maximum of 3.5% RMSE per the US Food and Drug Administration guidance. We performed a single-center, blinded hypoxia study of the test device in 11 healthy volunteers at the Hypoxia Research Laboratory, University of California at San Francisco, under the direction of Philip Bickler, MD, PhD, and John Feiner, MD. Each volunteer was connected to a breathing apparatus for the administration of a hypoxic gas mixture. To facilitate frequent blood gas sampling, a radial arterial cannula was placed on either wrist of each participant. One test device was placed on the index finger and another test device was placed on the fingertip. SaO2 analysis was performed using an ABL-90 multi-wavelength oximeter. For the 11 participants included in the analysis, there were 236, 258, and 313 SaO2-SpO2 data pairs for the test device placed on the finger, the test device placed on the fingertip, and the reference device, respectively. The RMSE of the test device for all participants was 2.1% for either finger or fingertip placement, while the Masimo Radical-7 reference pulse oximeter RMSE was 2.8%, exceeding the standard (4% or less) and the Food and Drug Administration guidance (3.5% or less). Accuracy of SaO2-SpO2 paired data from the 4 participants with dark skin in the study was separately analyzed for both test device placements and the reference device. The test and reference devices exceeded the minimum accuracy requirements for a medical device with RMSE at 1.8% (finger) and 1.6% (fingertip) and for the reference device at 2.9%. The wearable ring meets an acceptable standard of accuracy for clinical-grade SpO2 under nonmotion conditions without regard to skin color. ClinicalTrials.gov NCT05920278; https://clinicaltrials.gov/study/NCT05920278.