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Standards, Volume 6, Issue 3 (September 2026) – 6 articles

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10 pages, 180 KB  
Opinion
Digitalization, Digital Maturity and Information Security of Processes: Standard ISO 15189, ISO 17025, and EUROLAB Guide
by Marco Pradella
Standards 2026, 6(3), 31; https://doi.org/10.3390/standards6030031 - 7 Aug 2026
Viewed by 68
Abstract
Testing and medical laboratories have been undergoing a process of progressive, unstoppable digitalization. The digitalization of laboratories carries risks for information security. There are differences between medical laboratories according to International Organization for Standardization (ISO) 15189 and testing laboratories according to ISO 17025. [...] Read more.
Testing and medical laboratories have been undergoing a process of progressive, unstoppable digitalization. The digitalization of laboratories carries risks for information security. There are differences between medical laboratories according to International Organization for Standardization (ISO) 15189 and testing laboratories according to ISO 17025. ISO 15189 refers to information security based on ISO 27001, while ISO 17025 is limited to certain clauses. Medical laboratories can use the guidelines with sources from Clinical & Laboratory Standards Institute (CLSI) documents. The European Federation of National Associations of Measurement, Testing, and Analysis Laboratories (EUROLAB) provides a guide to digitalization security that combines ISO 17025 requirements with ISO 27001 controls. The Italian Society of Clinical Pathology and Laboratory Medicine (SIPMeL) Q18R1 Recommendations regarding requirements for medical laboratory information systems confirm that laboratories should obtain at least ISO/IEC 27001 certification. Full article
15 pages, 521 KB  
Article
Impact of Controlled Superheated Steam Conditions on a Commercial Peel-Pouch Sterile Barrier Systems: A Pilot Study
by William Leiva and Atila Nozari
Standards 2026, 6(3), 30; https://doi.org/10.3390/standards6030030 - 6 Aug 2026
Viewed by 75
Abstract
Saturated steam remains the primary sterilization modality in healthcare facilities globally; however, superheated steam may compromise sterile barrier integrity. Limited data characterize how superheated steam affects peel-pouch sterile barriers under controlled conditions. This pilot study evaluated peel-pouch performance under saturated steam control and [...] Read more.
Saturated steam remains the primary sterilization modality in healthcare facilities globally; however, superheated steam may compromise sterile barrier integrity. Limited data characterize how superheated steam affects peel-pouch sterile barriers under controlled conditions. This pilot study evaluated peel-pouch performance under saturated steam control and experimental superheated steam conditions. Seventy-two samples were exposed to four exposure scenarios using an ISO 18472:2018 compliant BIER vessel: control and experimental treatment at both 121 °C and 132 °C (N = 18 per group). Outcomes included visual inspection (cracking, discoloration, peel-off), bubble emission testing and peel strength testing. Fisher exact tests with Bonferroni correction evaluated categorical outcomes; two-way ANOVA evaluated peel force data. Visual damage showed no statistically significant difference across conditions (Fisher–Freeman–Halton exact test, p = 0.422), ranging from 5.6% in controls to 22.2% at 121 °C experimental conditions (OR = 4.85, p = 0.038). Pairwise odds ratio estimates suggested a possible increase in visible damage under experimental conditions; however, the overall comparison was not statistically significant. Bubble emission testing revealed highly significant differences (p = 0.0014), with experimental conditions showing 71.43% failure at 121 °C versus 11.11% in controls. Peel strength was dramatically reduced in experimental samples (47.4% reduction; F = 154.83, p < 0.0001), independent of temperature. Visual inspection failed to detect barrier compromises evident through functional and mechanical testing. In controlled laboratory conditions using a single peel-pouch brand, exposure to controlled superheated steam conditions was associated with significant barrier damage. These findings underscore the need for comprehensive barrier testing beyond visual inspection in sterilization validation. Full article
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21 pages, 1598 KB  
Article
Beyond Optimization: Legaliform (Law-like) Principles and Bounded Rationality in Lithic Technology
by Hugo Gabriel Nami
Standards 2026, 6(3), 29; https://doi.org/10.3390/standards6030029 - 5 Aug 2026
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Abstract
This article proposes a formal epistemological and methodological framework for the analysis of lithic technology, moving beyond traditional optimization-oriented models and normative typologies. Grounded in Mario Bunge’s socio-natural science and Herbert Simon’s theory of bounded rationality, we introduce the concept of legaliform (law-like) [...] Read more.
This article proposes a formal epistemological and methodological framework for the analysis of lithic technology, moving beyond traditional optimization-oriented models and normative typologies. Grounded in Mario Bunge’s socio-natural science and Herbert Simon’s theory of bounded rationality, we introduce the concept of legaliform (law-like) principles. These principles are defined as stable, necessary relationships between technical procedures and morphological outcomes, dictated by the physics of brittle fracture and enacted through procedural memory. To enhance analytical precision and cross-cultural comparability, we develop a semi-formal symbolic notation that identifies the core “techno-scientific” operators underlying lithic reduction. We argue that stone tool morphology is not a static reflection of a “mental template,” but a dynamic sequence of technically adequate states achieved through satisficing behavior. By framing these legaliform regularities as epistemological meta-standards, this article establishes a standardized framework for data reproducibility, verification, and quality control in technological analysis. The framework identifies eight primary legaliform principles—including bifacial reduction (PBR), thermal alteration (PTT), and maintenance and reactivation (PMR)—illustrating how they structure technical action under material and cognitive constraints. The utility of this approach is demonstrated through a case study of Paleoindian Fell projectile points in South America. By operationalizing the Maintenance and Reactivation Principle (PMR), we explain the high morphological variability of these points as a predictable result of life-history and functional restoration rather than cultural “drift” or failed design. This perspective provides a rigorous basis for identifying Guided Convergence in the archaeological record, offering a scientific alternative to diffusionist explanations and purely morphological comparisons that often overlook the underlying techno-scientific regularities of lithic practice. Full article
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31 pages, 626 KB  
Article
Toward a Public-Sector Resilience Reporting Standard for Low-Probability, High-Impact Systemic Risks: A Pre-Standard Architecture for Government Preparedness Under Deep Uncertainty
by Haris Alibašić
Standards 2026, 6(3), 28; https://doi.org/10.3390/standards6030028 - 28 Jul 2026
Viewed by 183
Abstract
Public-sector sustainability and climate reporting increasingly address environmental exposure, governance, and financial effects, yet existing frameworks do not adequately disclose preparedness for low-probability, high-impact systemic risks whose probabilities, timing, thresholds, and transmission channels remain deeply uncertain. This article develops a Public-Sector Resilience Reporting [...] Read more.
Public-sector sustainability and climate reporting increasingly address environmental exposure, governance, and financial effects, yet existing frameworks do not adequately disclose preparedness for low-probability, high-impact systemic risks whose probabilities, timing, thresholds, and transmission channels remain deeply uncertain. This article develops a Public-Sector Resilience Reporting Standard (PSRRS) as a pre-standard architecture for government preparedness disclosure. The design has three bounded objectives: diagnose cross-framework disclosure gaps, translate these gaps into a theoretically grounded capability-to-disclosure architecture, and demonstrate its analytical use through an illustrative Florida application and two hazard-neutral stress tests. The documentary corpus includes international sustainability and public-sector reporting standards, ISO and UNDRR resilience and continuity instruments, three Florida resilience documents, and peer-reviewed literature on resilience governance, decision-making under deep uncertainty, critical infrastructure interdependency, catastrophic uncertainty, climate-risk disclosure, public finance, climate-risk pricing, local-government credit risk, investor attention, and ransomware service disruption. A structured interpretive coding protocol classifies each framework as explicit, partial, or not explicit across nine disclosure dimensions; a codebook appendix identifies the assessment criteria, the a priori and inductively refined dimensions, and the validation boundaries. Florida is not treated as a basis for statistical or jurisdictional generalization. Instead, it illustrates how a comparatively developed resilience architecture may disclose statutory continuity, critical-asset data, project ranking, and output metrics while leaving systemic dependencies, adaptive triggers, long-horizon fiscal exposure, residual service risk, distributional effects, and assurance mechanisms insufficiently visible in the reviewed reporting corpus. AMOC and case-grounded cyber-fiscal stress tests show how the PSRRS shifts reporting from hazard inventories and funded projects toward auditable evidence of institutional capacity, adaptive readiness, and public-value protection. The article specifies mandatory, recommended, and optional clauses, evidence requirements, indicator examples, a disclosure index, a sample report structure, and a three-tier pilot conformity model. The contribution is conceptual and operational, but not yet a validated formal standard; cross-jurisdictional piloting, inter-rater coding, cost testing, assurance testing, and stakeholder consultation are identified as the next stage of standardization. Full article
(This article belongs to the Special Issue Sustainability Reporting Standards for the Public Sector)
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16 pages, 859 KB  
Article
Study on the Kinetics of Vitamin U Release from a Cosmetic Formulation
by Małgorzata Kucia, Agnieszka Leśniak and Elżbieta Sikora
Standards 2026, 6(3), 27; https://doi.org/10.3390/standards6030027 - 16 Jul 2026
Viewed by 228
Abstract
S-Methylmethionine (SMM), also called vitamin U, shows antihistamine, anti-inflammatory, radioprotective and anti-irritant activity, as well as enhanced wound healing. In addition, vitamin U affects the regeneration and renewal of the skin hydrolipid mantle and offers some UVB-protective effects on the skin. Since there [...] Read more.
S-Methylmethionine (SMM), also called vitamin U, shows antihistamine, anti-inflammatory, radioprotective and anti-irritant activity, as well as enhanced wound healing. In addition, vitamin U affects the regeneration and renewal of the skin hydrolipid mantle and offers some UVB-protective effects on the skin. Since there are currently no reports in the scientific literature concerning the release of vitamin U from cosmetic formulations, the present study was undertaken as a preliminary and exploratory pilot investigation. The research focused on evaluating the release behavior of SMM (synthetic methylmethionine), a compound recognized for its potential skin-regenerating, soothing, and protective properties, from several commonly used topical delivery systems. Therefore, the various topical formulations, including oil-in-water (O/W) and water-in-oil (W/O) emulsions, as well as hydrogel formulations, were evaluated as potential, effective vitamin U skin delivery systems. Vitamin U-loaded emulsions (O/W and W/O) differing in droplet size in the internal phase and a hydrogel were prepared. The physicochemical properties of the formulations, such as emulsion type, stability, viscosity, pH and droplet size, were evaluated. The study of vitamin U release was performed in thermostatic diffusion chambers at a temperature of T = 32 °C using the Spectra/Por Standard Regenerated Cellulose dialysis membrane. A phosphate buffer (PBS) with pH 7.4 was used as the receptor solution. The concentration of the released S-Methylmethionine was analyzed with ninhydrin-based spectrophotometric assays. The obtained results showed that the type of the formulation significantly influenced the SMM release. The highest release of SMM was observed from hydrogel and O/W emulsions. Full article
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17 pages, 2320 KB  
Article
A Standardised Protocol for Assessing Aquaculture Effluent Suitability for Microalgae Cultivation: Validation Using Phaeodactylum tricornutum and Biofloc Shrimp Effluent
by Victor Jorge da Cruz, Thiago César dos Santos, Rafael Garcia Lopes, Marco Shizuo Owatari and Roberto Bianchini Derner
Standards 2026, 6(3), 26; https://doi.org/10.3390/standards6030026 - 15 Jul 2026
Viewed by 333
Abstract
There is a notable lack of standardised and validated protocols for evaluating the potential of aquaculture effluents as culture media for microalgae. This study addresses this gap by developing and validating a comprehensive protocol for assessing the suitability of aquaculture effluents for microalgal [...] Read more.
There is a notable lack of standardised and validated protocols for evaluating the potential of aquaculture effluents as culture media for microalgae. This study addresses this gap by developing and validating a comprehensive protocol for assessing the suitability of aquaculture effluents for microalgal production. The protocol was designed and standardised based on effluent characterisation, effluent pre-treatment, standardised inoculation, assessment of microalgal growth performance, and evaluation of nutrient removal. Validation was conducted through the cultivation of Phaeodactylum tricornutum in biofloc technology (BFT) shrimp (Penaeus vannamei) effluent, demonstrating the protocol’s reliability, robustness, and adaptability across media with varying nutrient profiles. The approach effectively identified nitrate and orthophosphate removal patterns of up to 97.34 ± 2.15% and 87.88 ± 1.61%, respectively, in culture media containing 100% shrimp effluent, while providing consistent and accurate growth performance data across different treatments. The treatment containing 100% shrimp effluent achieved a maximum cell density of 8488 ± 772 (×104 cells mL−1). As the proposed framework is based on broadly applicable performance indicators, it provides a methodological basis that can be adapted for evaluating other aquaculture effluents, microalgal species, and cultivation systems. However, additional validation under these conditions is required before broader application can be confirmed. Full article
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