International Organization For Standardization Research Articles

Marine exploration and its environmental impact assessment: insights from international standards

Rising demand for marine resources has led to a great interest in seabed exploration and mining, while deep-sea environments are faced with cumulative effects of many human activities. Currently, conducting an environmental impact assessment for deep-sea exploration and mining is challenging due to the dynamic nature and a lack of high-quality data. The International Seabed Authority (ISA), which charges with regulating human activities on the seabed beyond the continental shelf, requires contractors to establish both geological and environmental baselines. Also, the ISA provides a general environmental guideline for exploring various seabed resources. However, standardization of its implementation would need to be addressed with specified technical international standards. The marine technology subcommittee of International Standardization Organization (ISO) contributes to the study of standards on deep-sea geological, geophysical and biological surveys, also on marine environmental protection. In this review, we explore two broad aspects of ISO standards: (1) the development of marine geological and geophysical exploration standard, which may help to establish geological map in the seabed area. (2) the current state of development of a series of Marine Environmental Impact Assessment (MEIA) standards, which could standardize the environmental surveys and monitoring activities in the seabed area. We also consider the standardization gap between MEIA and seabed mining, and propose future focus on coordination relationship between marine exploration and environmental protection.

Validating the accuracy of Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure according to the ISO 81060-2:2018+Amd 1:2020 protocol in the general population.

The performance of the Omron HEM-7372T1-AZAZ (BP5460) in monitoring blood pressure (BP) in the upper arm was validated in accordance with the International Organization for Standardization (ISO) 81060-2:2018 (E) and amendment (Amd)1:2020 protocol. The device was used to assess 98 participants who fulfilled the inclusion criteria, including the range of arm circumference and systolic and diastolic BP, in accordance with the protocol. Data validation and analysis were performed according to the manufacturer's instructions. In the ISO validation procedure (criterion 1), the mean ± SD of the differences between test device readings and reference BP was 0.3 ± 6.17/3.6 ± 5.26 mmHg (systolic/diastolic). These data fulfilled the ISO requirements of ≤5±≤8 mmHg. The mean differences between the observer measurements and Omron HEM-7372T1-AZAZ (BP5460) readings were 0.3 ± 4.82 mmHg for systolic BP and 3.6 ± 4.78 mmHg for diastolic BP, fulfilling criterion 2 with SD values of ≤6.95 for SBP and ≤5.89 for DBP. Therefore, two ISO criteria were fulfilled. The Omron HEM-7372T1-AZAZ BP monitor fulfilled the requirements of the ISO validation standard. This device can be recommended for home BP measurements in the general population.

The impact of hyperbaric oxygen treatment for cardiovascular implantable electronic devices.

The safety of hyperbaric oxygen treatment (HBO2) in patients with cardiovascular implanted electronic devices (CIED) remains unclear. We conducted a retrospective analysis of seven CIED patients (median age 79 [73-83] years, five males [71.4%]), including five with pacemakers and two with implantable cardioverter defibrillators (ICD), who underwent HBO2 between June 2013 and April 2023. During the initial session, electrocardiogram monitoring was conducted, and CIED checks were performed before and after the treatment. In addition, the medical records were scrutinized to identify any abnormal CIED operations. All seven CIED patients underwent HBO2 within the safety pressure range specified by the CIED manufacturers or general pressure test by the International Organization for Standardization (2.5 [2.5-2.5] atmosphere absolute × 18 [5-20] sessions). When comparing the CIED parameters before and after HBO2, no significant changes were observed in the waveform amplitudes, pacing thresholds, lead impedance of the atrial and ventricular leads, or battery levels. All seven patients, including two with the rate response function activated, exhibited no significant changes in the pacing rate or pacing failure. Two ICD patients did not deactivate the therapy, including the defibrillation; however, they did not experience any arrhythmia or inappropriate ICD therapy during the HBO2. CIED patients who underwent HBO2 within the safety pressure range exhibited no significant changes in the parameters immediately after the HBO2 and had no observable abnormal CIED operations during the treatment. The safety of defibrillation by an ICD during HBO2 should be clarified.

Exploring the relationship between Lean and Green for further research

PurposeExploring the Lean and Green relationship goes back to the beginnings of Lean manufacturing. Most cases established that companies implementing Lean have Green results. However, there are Lean practices with a higher impact on Green, but others with less impact. Therefore, this paper presents research that explores the relationship between Lean and Green in manufacturing companies and aims to determine whether Lean practices have a higher association with Green aspects.Design/methodology/approachA survey was conducted amongst manufacturing firms to determine their Lean Index (LI). The internally related elements of the Lean construct determined each firm’s LI, whilst Cronbach alpha determined internal LI consistency. The survey also identified firms developing six Green aspects: International Organisation for Standardisation (ISO) 14001, ISO 50001, general Green aspects and the specific aspects of materials, energy and water. An individual sample t-test shows different LI levels of association for each Green aspect. Binomial logistic regression shows the LI element association for each Green aspect.FindingsLI is higher at firms reporting the inclusion of Green aspects. More than half of LI components have a statistically relevant association with the six Green aspects. In general, Ishikawa diagrams had the highest association with Green aspects whilst the lowest was seen in workers as improvement initiators. By grouping the LI elements into their categories, the Lean practices related to controlling processes have a higher association, whilst the involvement of employees has the lowest.Research limitations/implicationsFurther research found in this paper identifies the possibilities for investigating the specificities of each Lean tool to develop Green aspects in companies.Practical implicationsPractitioners learn that Lean and Green are not separate issues in business. This article provides evidence that Lean practices in place at companies are already associated with Green aspects, so integration may already be happening.Originality/valueThis paper provides specifics on the relationship between each Lean practice and developing Green aspects. Thus, this paper specifies the Lean practices that contribute most to Green efficiency to support the joint development of both themes.

Digital twin supporting environmental performance evaluation according to ISO certification: an application case in the tire industry

ABSTRACT The link between digital evolution and environmental sustainability is reshaping how companies enhance their processes, contributing to address circular manufacturing (CM). The extant literature does not explain how to improve the tire production process to limit environmental negative impacts, which are its most critical phases, which Industry 4.0 technologies could be exploited and how they could intervene in the process to facilitate effective data management. This research proposes a framework indicating how digital technologies could support tire producers in reducing the ecological footprint of their operations. The proposed framework addresses ISO 14,046 and 14,067 International Organization for Standardization (ISO) certifications. Digital twin (DT) was chosen as the most suitable technology. The related framework was further detailed according to data-driven CM principles, providing the set of sensors to be embedded on the production process and defining the data and information to be gathered through them to address the requested ISO certifications.

Industrial sustainable Fabrication, SEM Characterization, mechanical Testing, ANOVA analysis of PP-PETF recycled Composites: Artificial intelligence and deep learning studies for nuclear shielding applications

The sustainable processing of polymeric waste is required innovation. In this article, polypropylene (PP)- polyethylene terephthalate fiber (PETF) composite materials were fabricated according to the International Organization for Standardization (ISO 9001–2 and 2008) for commercial manufacturing using extrusion and injection molding. The variations of 0, 10, 30, and 40 % of PETF loadings were utilized for mechanical properties’ optimization. The results indicate that tensile strength, strain, and young’s modulus of elasticity were in the range of 22–25 MPa, 3–5 % and 870–1167 MPa. Correspondingly, the values of flexural strength, strain and modulus constant were in the range of 39–40 MPa, 9–12 % and 1909–2140 MPa, respectively. The impact energies were in the range of 2.6–3.4 kJ/m2. Thermally, the PP-PETF composites were found stable. The scanning electron microscope characterization, presence of induced micro defects, optimum flake structure, analysis of variance, deep learning, and artificial intelligence studies predict the utilization of PP-PETF composites for manufacturing of panels and sheets regarding static loading bearing applications. The reported technical strategies can be utilized as a reference processing technique for industrial manufacturing of PP-PETF based recycled composite products.

Comparison of colorimetric methods for the analysis of total polyphenols in green tea extracts.

Two colorimetric methods are used to determine the total polyphenol contents of tea, namely, "the Folin-Ciocalteu method," defined by the International Organization for Standardization, and the "iron tartrate method," specified in the Standard Tables of Food Composition in Japan. In this study, we compared the Folin-Ciocalteu and iron tartrate methods using green tea extracts. When comparing the 2 methods, the sum of the 4 major catechins measured using high-performance liquid chromatography (HPLC) was regarded as the standard value. The total polyphenol contents obtained using the Folin-Ciocalteu method were closer to the HPLC value than those obtained using the iron tartrate method. However, the iron tartrate method is adequate if the current official method is improved, that is, our results suggest that the coefficients appropriate for common green tea varieties, as well as the degree and duration of cover cultivation, in the official iron tartrate method must be considered.

Effect of non-contact induction heating on HA coatings and bone cement, an ex vivo study

Background Prosthetic joint infection is a serious complication that can arise after total joint replacement surgery. When bacteria colonise an orthopaedic implant, they form biofilms that protect them from their environment, making them difficult to remove. Treatment is further complicated by a global rise of antimicrobial resistance. These protective mechanisms make treatment of prosthetic joint infection increasingly complex. Non-contact induction heating is an upcoming technology that uses heat to eradicate bacteria that are present on the surface of metallic implants. This study aims to provide insight into the feasibility of using non-contact induction heating on metallic implants that are in direct contact with other biomaterials, such as coatings composed of hydroxyapatite and bone cement composed of poly (methyl methacrylate) (PMMA). Methods Characterisation of hydroxyapatite coatings and adhesion strength tests were conducted according to standards set by the International Organisation for Standardisation (ISO 13779-2). The fixation strength of acrylic bone cement was tested according to an adapted method from ISO. Results It was found that non-contact induction heating did not significantly affect the adhesion strength of hydroxyapatite coatings (p=0.697). In contrast to hydroxyapatite coatings, acrylic bone cement softened temporarily as the temperature exceeded the glass transition temperature (83.38 ± 10.88°C). However, the induction heating temperature had no significant effect on the fixation strength after the cement was allowed to cool down (p=0.535). Conclusion This study shows the feasibility of using non-contact induction heating up to 80°C when bone cement or ceramic coatings are present in contact with infected metallic implants.

Comparative Evaluation of Sorption and Solubility of Core Buildup Materials in Different pH Media: An In-Vitro Study.

To evaluate and compare the sorption and solubility of two different core buildup materials in different pH media for periods of one day, one week, and one month. Sixty samples were prepared and divided into Group A (30 resin-based samples) and Group B (30 glass ionomer cement (GIC)-based samples). The sorption and solubility of the different materials were calculated by weighing the samples before and after desiccation and media immersion for periods of one day, one week, and one month. Groups were compared using the Mann-Whitney U test, and for different media, the intragroup significance of the mean difference was performed using the Friedmann test and Wilcoxon signed rank test at a significance level of p<0.05. After immersion for different time periods, the resin-based core buildup material (Core X flow) showed less sorption and solubility as compared to the glass ionomer-based core buildup material (Secure Core Z) for all time periods, with a significant difference seen for a time period of one week and one month and being nonsignificant for a time period of one day. Core X flow had lower sorption and solubility values when compared to Secure Core Z, as per the International Organization for Standardization (ISO) 4049 standards, except for a one-month time period in alkaline media.

Effective orifice diameter: a new sizing parameter of surgical valve prostheses to inform valve selection.

The labeled sizes of surgical valve prostheses and their discordance with the physical internal valve orifice sizes has long been a controversy in the cardiac surgery community, leading many to believe it to be a contributing factor in prosthesis-patient mismatch following valvular replacement surgery. In an attempt to address this issue, the International Organization for Standardization (ISO) 5840-2:2021 standard for surgical valve prostheses recommends that a new sizing parameter, namely, the effective orifice diameter, be provided in labeling by all manufacturers as an indicator of the true flow-passing capacity of a prosthetic valve. The ISO Cardiac Valves Working Group conducted a multi-laboratory round-robin study to investigate whether the effective orifice diameter of a prosthetic surgical valve could be derived repeatably and reproducibly through steady forward-flow testing. A total of seven valve models, each with multiple sizes, were tested, including a mechanical heart valve and multiple biological heart valves. The round-robin study confirmed that the steady forward-flow test had good intra-laboratory repeatability and inter-laboratory reproducibility in deriving the effective orifice diameters of surgical valve prostheses. On average, among the participating laboratories, the experimentally derived effective orifice diameter of a prosthetic heart valve was 3-12 mm smaller than its labeled size. The effective orifice diameter provides better characterization of the hydrodynamic characteristics of a surgical valve prosthesis and can be derived using a validated steady forward-flow test method. This new sizing parameter will soon be adopted by surgical valve manufacturers and provided in device labeling to inform valve selection by surgeons.

A modular ontology modeling approach to developing digital product passports to promote circular economy in the built environment

The significant impact of the built environment on resource consumption and waste production has led to calls for a shift towards a circular economy model that maximizes the efficient use of resources. This study explores the use of digital product passports (DPPs) to improve how we manage products throughout their lifecycle. However, dealing with the complexity and large volume of data in DPPs can be challenging in terms of effective information management and utilization. We address this issue by adopting a modular ontological approach to systematically capture product lifecycle information from its origin to its end-of-life phase. To ensure interoperability and reusability of the ontology, we annotate key concepts and relationships using International Organization for Standardization (ISO) standards that promote circular economy. Our research led to the development of several ontology modules derived from literature reviews and interviews conducted with industry and academia experts who specialize in sustainability. These modules were then integrated to create a digital product passport ontology. The study demonstrates the feasibility of using a modular ontology approach to manage the complex information inherent in DPPs paving the way for more sustainable management practices in the built environment sector.

An improved implementation of metrological traceability concepts is needed to benefit from standardization of laboratory results.

Non-harmonization of laboratory results represents a concrete risk for patient safety. To avoid harms, it is agreed that measurements by in vitro diagnostic medical devices (IVD-MD) on clinical samples should be traceable to higher-order references and adjusted to give the same result. However, metrological traceability is not a formal claim and has to be correctly implemented, which in practice does not happen for a non-negligible number of measurands. Stakeholders, such as higher-order reference providers, IVD manufacturers, and External Quality Assessment organizers, have major responsibilities and should improve their contribution by unambiguously and rigorously applying what is described in the International Organization for Standardization 17511:2020 standard and other documents provided by the international scientific bodies, such as Joint Committee on Traceability in Laboratory Medicine and IFCC. For their part, laboratory professionals should take responsibility to abandon non-selective methods and move to IVD-MDs displaying proper selectivity, which is one of the indispensable prerequisites for the correct implementation of metrological traceability. The practicality of metrological traceability concepts is not impossible but relevant education and appropriate training of all involved stakeholders are essential to obtain the expected benefits in terms of standardization.

Workshop covers alternative test methods using multivariate spectroscopy

International standards organisation ASTM International is running a workshop on 17 June 2024, in Austin, Texas, USA, under the theme ‘Alternative Test Methods using Multivariate Spectroscopy for Lab and Online Systems’.

LinkedDataOps:quality oriented end-to-end geospatial linked data production governance

This work describes the application of semantic web standards to data quality governance of data production pipelines in the architectural, engineering, and construction (AEC) domain for Ordnance Survey Ireland (OSi). It illustrates a new approach to data quality governance based on establishing a unified knowledge graph for data quality measurements across a complex, heterogeneous, quality-centric data production pipeline. It provides the first comprehensive formal mappings between semantic models of data quality dimensions defined by the four International Organization for Standardization (ISO) and World Wide Web Consortium (W3C) data quality standards applied by different tools and stakeholders. It provides an approach to uplift rule-based data quality reports into quality metrics suitable for aggregation and end-to-end analysis. Current industrial practice tends towards stove-piped, vendor-specific and domain-dependent tools to process data quality observations however there is a lack of open techniques and methodologies for combining quality measurements derived from different data quality standards to provide end-to-end data quality reporting, root cause analysis or visualisation. This work demonstrated that it is effective to use a knowledge graph and semantic web standards to unify distributed data quality monitoring in an organisation and present the results in an end-to-end data dashboard in a data quality standards-agnostic fashion for the Ordnance Survey Ireland data publishing pipeline.

Verification of analytical performance of Unsaturated iron binding capacity (UIBC) assay on the Abbott Alinity ci®: Experience of the central laboratory of Mohammed VI University Hospital of Oujda

The verification of analytical methods is a requirement outlined by the International Organization for Standardization (ISO). This process involves evaluating the performance of an analytical method according to a well-defined protocol and subsequently comparing it with pre-established analytical objectives. In our study, we conducted an evaluation of the analytical performance of the unsaturated iron binding capacity assay using the Abbott kit on the Alinity CI analyzer in the biochemistry laboratory of Mohammed VI University Hospital in Oujda. The methodology employed adheres to the recommendations of the French accreditation committee (COFRAC) accreditation technical guide SH GTA 04, focusing on the assessment of reproducibility and repeatability. Overall, the results obtained from the study are considered satisfactory and align with the acceptability criteria recommended by the supplier. It's important to note that the accuracy and reliability of examination results are influenced not only by laboratory personnel, equipment, and environmental conditions, but also by the methods utilized and their eventual validation or verification.

TOXICITY OF LITHIUM BATTERY WASTE ON SELECTED INVERTEBRATES

Electronic waste poses a major menace to ecosystems owing to the toxic properties of materials used for the manufacture of electronic goods. In this present study, the toxicity of lithium battery waste on invertebrates, snails (Archachatina marginata) and earthworms (Apporrectodeal longa) were evaluated using appropriate concentrations of toxicant. The physicochemical and heavy metal analysis of the toxicant was carried out according to the method of APHA (2008). The standard protocol obtained from the Organization for Economic Cooperation and Development (OECD) and the protocol obtained from the International Organization for Standardization (ISO) were adopted for the 14-day exposure to varying concentrations of the toxicant (0.3125, 0.625, 1.25, 2.5 and 5.0 mg/kg) for earthworm and (3.125,6.25, 12.5, 25 and 50 mg/kg) for snail respectively. The pH, Electrical conductivity. Total dissolved solids, Lithium, cadmium and mercury results of the toxicant were (2.6, 13500, 8640, 36.60, 2.03 and 10.48mg/L) respectively. The result also shows an increased in the mortality of test organisms with increase in toxicant concentration. LC50, LOEC, NOEC, TUc and TUa with exposure time for snails and earthworms were (1.05, 0.86,0.77,94.88, 129.87 mg/kg) and (0.68, 0.41,0.31, 147.06, 322.58.mg/kg), respectively. The study established that the toxicant (lithium battery) is considered a high risk to animals, plants and the environment as it adversely affects soil invertebrates which bring about soil fertility if not properly disposed of.

ISO 14001 Environmental Standard: Process Approach and Identification of Environmental Aspects and Impacts

Environmental management is the management of activities that may have an impact on the environment. It aims to limit polluting emissions and risks to the environment and to save natural resources. Often unsuspected and therefore without us always realizing it, all economic activities can have a considerable impact on the environment. Indeed, the manufacture of products requires the extraction of raw materials and the use of water and energy. Similarly, activities associated with the manufacturing process, such as maintenance, transportation; all have environmental impacts. The environmental management system is a progress tool that integrates the environmental dimension into an organization’s strategy, leading it to set objectives, achieve and maintain performance through effective management and promotes anticipation (the forecast). There is a multitude of guides allowing self-diagnosis by the organization and which make it possible to make an environmental assessment. ISO 14001 is the environmental management standard (EMS) created by the international organization for standardization. It defines the requirements of a global environmental management system for self-reporting or certification purposes. It is organized in 17 points modeled on quality management, well known for 34 years in the industry. The standard does not establish any absolute requirement for environmental performance, other than a commitment to environmental policy, to comply with legislation and the principle of continuous improvement. Pollution prevention through the identification of the various significant environmental aspects and impacts, which accounted for 70% of the requirements of ISO 14001, is the main environmental improvement point. In addition, since these environmental aspects and impacts can only be identified from the activities, products and services associated with them, this article represents a working method that allows expressing good environmental practices, present in the form of environmental performance indicators that inform in a concentrated and precise manner on the different activities with environmental relevance.

Evaluation of quality indicators in microbiology and infectious disease serology laboratory: A study from a tertiary cancer care centre in Gujarat, India

Introduction: Quality indicators (QIs) are important for the monitoring and evaluation of laboratory performance at pre-analytical, analytical, and post-analytical phases. Errors in the laboratory arise more frequently before and after the analysis of samples. The total testing process (TTP) therefore needs to be evaluated for good laboratory performance. A good quality indicator should give information about the performance of a process, thereby governing the quality of services.Objective: To analyse TTP and QIs for a period of six years of screening of laboratory performance.Methods: This retrospective analysis was conducted for the period 2017 to 2022. QIs at pre-analytical (12), analytical (04) and post-analytical (03) phases were defined and analysed on a monthly basis. The laboratory followed the guidelines of the International Organization for Standardization (ISO) 15189:2012 to identify errors in all sections.Results: A total of 259,694 samples were received during the study period. A total of 628,817 tests were performed. The overall error rate was 1.25/1000 tests. Error in the pre-analytic phase was 0.96/1000 tests, the commonest being haemolysed samples. Error in the analytical phase was 0.33/1000 tests. The error of postanalytical phase was 0.48/1000 tests with turn round time (TAT) outliers being the commonest.Conclusion: Amongst all phases of QIs, errors were minimum in the analytical phase. Continuous monitoring and analysis of QIs helps in identification of common errors in the laboratory. Corrective measures will help to improve quality of the laboratory services, and hence the patient outcome. Regular training, evaluation of technical staff, regular preventive maintenance and calibration of all analytical instruments helps in reducing the errors.

ISO 59000 Standards for the Circular Economy: a Call for Accuracy

With the expressed aim of reducing uncertainty and lack of precision about the Circular Economy paradigm, several standards are being proposed by standard-setting bodies. The world’s most prominent body — the International Organization for Standardization — is developing the ISO 59000 family of standards to establish a common language and conceptual framework for the Circular Economy. In the light of the vigorous debate in the scientific literature about the Circular Economy, as well as criticism of the concepts involved, this perspective article calls for more precision in the definition of this type of standard.

Integrating management systems in the energy sector: the case of the electricity industry in New Zealand

The New Zealand Electricity Engineers Association (EEA) asked for advice about development of a guide for a public safety management system (PSMS) for electricity distribution networks based on ISO45001 Occupational health and safety management systems. This would help eliminate overlap between legislation and standards while maintaining compliance with legal requirements. At Victoria University of Wellington we have been working on such an integrated approach and this article reports on the project and suggests how the results can be extended to include other areas of management while retaining the ability for appropriate elements to be audited and certified in accordance with systems required by legislation. The project reviewed an earlier report and literature review on PSMS for the Electricity Networks Association. Development of the legal requirements for a PSMS were reviewed and use of the International Standards Organization (ISO) framework for all management system standards proposed to encompass ISO45001 and similar standards. Relevant management content was incorporated in the high-level structure and key stakeholders contributed technical content. Use of the ISO Annex SL as a template enabled development of an integrated management system incorporating other management system standards, that would still support legal compliance while enabling elimination of duplication and clutter, and waste of resources at a time of technology change. The work was carried out in New Zealand (NZ) and may not apply in other countries with different legal requirements. Auditors may resist integrated management systems although this may not be a limitation if documentation is appropriately written. The electricity networks businesses in NZ may move to implementation of the PSMS guide but this will be an internal decision and results may take some years to declutter documentation and reduce overlapping audits under management system standards. Over the next decade the context of the New Zealand electricity industry will undergo major shifts with the need to adapt to increasing expectations for occupational health and safety and public safety, adaptation to climate change and accelerated implementation of new technologies. The electricity industry will need to apply its resources to those changes while avoiding duplicated efforts to implement multiple management systems. Developing an integrated management system that incorporates several management systems and public safety may aid protection of non-workers who cannot otherwise be “controlled” by a business.