Monthly Roundup: HEALTH CARE TECHNOLOGY Standards from May 2025

Looking back at May 2025, the Health Care Technology sector experienced a significant wave of standardization activity, reflecting ongoing shifts in global health priorities. Five key standards were published this month, each addressing industry imperatives spanning transfusion safety, infection control, AI-enhanced diagnostics, medicinal product quality, and accessible living systems. For professionals invested in quality, compliance, or the advancement of medical and health-related technologies, this retrospective offers a curated synthesis of the month’s developments—helping you navigate new requirements, decipher industry direction, and plan strategic responses.

Monthly Overview: May 2025

May 2025 marked a notable period for Health Care Technology standardization, characterized by both technological innovation and a commitment to patient-centered care. The month’s publications covered a breadth of domains—from single-use transfusion equipment to the application of AI in dental radiographs, traditional herbal medicine safety, new approaches in accessibility, and advances in washer-disinfector validation for non-critical devices. Compared to typical monthly activity, there was a marked increase in standards addressing both digital transformation and inclusivity, underlining an industry-wide pivot to holistic health outcomes and regulatory harmonization.

This month's portfolio suggests a sector focused on quality and safety, digitalization, and the removal of barriers—for both professionals and patients. The expansion into artificial intelligence, increased specificity around accessible living solutions, and the globalization of medicinal product quality collectively indicate an adaptive, responsive Health Care Technology environment.

Standards Published This Month

ISO 1135-5:2025 - Transfusion Sets for Single Use with Pressure Infusion Apparatus

Transfusion equipment for medical use – Part 5: Transfusion sets for single use with pressure infusion apparatus

ISO 1135-5:2025 specifies the requirements for single-use transfusion sets designed for use with pressure infusion equipment. Its scope ensures such sets are both compatible with standard blood containers and intravenous devices, and safe for administration under pressure, which is critical for emergency transfusions or high-demand clinical settings. Key provisions address physical attributes (such as tensile strength and leakage resistance), chemical and biological safety (including sterility and hemocompatibility assessments per ISO 10993-1), and comprehensive labeling and packaging controls reflective of the latest advances in usability and safety.

Targeted primarily at transfusion device manufacturers, blood banks, healthcare providers, and regulatory agencies, this standard ensures harmonization of material quality, designations, and compatibility across global systems. The 2025 revision introduced updated definitions for key volume parameters, improvements to injection site usability (emphasizing needle-free safety), clarified contamination prevention via protective caps, and implementation of the latest biological risk methodologies.

Key highlights:

• Redefined parameters for filling, storage, and post-occlusion volumes
• Updated safety features for injection ports and protective caps
• Enhanced biological risk and hemocompatibility assessment per ISO 10993 series

Access the full standard:View ISO 1135-5:2025 on iTeh Standards

ISO 19842:2025 - Traditional Chinese Medicine – Dioscorea Opposita Rhizome

Traditional Chinese medicine – Dioscorea opposita rhizome

ISO 19842:2025 establishes internationally harmonized quality and safety specifications for the Dioscorea opposita rhizome, a widely used herbal ingredient in traditional Chinese medicine (TCM) and related pharmacopoeias. The standard delineates testing and acceptance criteria for moisture, total ash, heavy metals, pesticide residues, and sulfur dioxide content, accompanied by validated methodologies such as thin-layer chromatography (TLC) for identity. It applies to both whole medicinal materia medica and decoction pieces intended for global trade, harmonizing disparate regional and national requirements and promoting safe, high-quality natural medicines.

Intended for herbal product manufacturers, importers, regulatory authorities, and quality auditors, this document fosters global trade transparency and consumer safety. By codifying sampling, packaging, storage, and marking norms, ISO 19842 encourages best practices and helps bridge gaps between traditional practice and modern regulatory expectations for natural health products.

Key highlights:

• Unified international quality and safety benchmarks for Dioscorea opposita rhizome
• Test method requirements for impurities, residues, and content uniformity
• Comprehensive guidance on sampling, packaging, and labelling for the global marketplace

Access the full standard:View ISO 19842:2025 on iTeh Standards

EN 17999:2025 - Accessible Systems for Living Independently

Accessible systems for living independently – Requirements and recommendations

EN 17999:2025 outlines comprehensive requirements and recommendations for accessible systems for living independently (ASLI), focusing on product and service design that supports autonomy and participation across a broad user spectrum. The standard encompasses the technical, human-interface, and service provision aspects required for accessible solutions in domestic environments—addressing not only the hardware but also accompanying informational and support services.

This guidance is relevant for manufacturers of assistive and smart home technologies, designers, service providers, public authorities, and installation contractors. It mandates that systems for living independently—whether security, comfort, or care-focused—be adaptable and usable by individuals of varying abilities, ensuring equal access and supporting integration with both mainstream and assistive technologies. While system-to-system communication is specifically excluded, the standard’s holistic approach fosters inclusive design throughout the lifecycle of ASLI.

Key highlights:

• Holistic ASLI requirements including information, installation, and maintenance services
• Equal access and usability, supporting the full range of user capabilities
• Strong emphasis on interoperability with both mainstream and assistive technology

Access the full standard:View EN 17999:2025 on iTeh Standards

EN ISO 15883-7:2025 - Washer-Disinfectors: Chemical Disinfection for Non-Critical Thermolabile Devices

Washer-disinfectors – Part 7: Requirements and tests for washer-disinfectors employing chemical disinfection for non-critical thermolabile medical devices and health care equipment (ISO 15883-7:2025)

EN ISO 15883-7:2025 defines stringent requirements and performance tests for washer-disinfectors used to clean and chemically disinfect reusable, non-critical, thermolabile medical devices and equipment—such as bed frames, surgical tables, medical carts, wheelchairs, and aids for persons with disabilities. By specifying test methods for type, installation, operational, and performance qualification, as well as periodic requalification after essential repair, this standard ensures these disinfectors operate safely and effectively in clinical environments.

The standard is essential for health care providers, sterilization departments, washer-disinfector manufacturers, and quality auditors. It supplements existing regulatory frameworks, specifically the EU Medical Devices Regulation (2017/745), by mapping requirements that confer presumption of conformity for safety and performance obligations. The 2025 revision updated cross-references, clarified requirements for chemical disinfection, and reinforced procedures for documentation, control, and validation.

Key highlights:

• Comprehensive requirements for cleaning/disinfection of non-critical thermolabile devices
• Integration with quality management, risk management, and EU regulatory frameworks
• Detailed protocols for periodic and post-repair requalification

Access the full standard:View EN ISO 15883-7:2025 on iTeh Standards

EN ISO 18374:2025 - Dentistry: AI and Augmented Intelligence in 2D Radiograph Analysis

Dentistry – Artificial intelligence (AI) and augmented intelligence (AuI) based 2D radiograph analysis – Data generation, data annotation and data processing (ISO 18374:2025)

EN ISO 18374:2025 addresses the burgeoning field of artificial and augmented intelligence (AI/AuI) in dental diagnostics, establishing requirements for developing, documenting, and validating software used for 2D radiographic image analysis. The standard details procedures for the curation and annotation of training, validation, and testing data; emphasizes bias analysis and data protection; and specifies the documentation required to articulate intended use, limitations, and patient populations for AI-enabled tools.

Relevant for dental software developers, radiologists, clinics, and product regulators, this standard enhances trust in AI-driven diagnostics by mandating transparent, reproducible data handling and validation. It covers solely static (non-dynamic) AI/AuI applications, providing a valuable framework for product certification and regulatory acceptance worldwide.

Key highlights:

• Structured requirements for data handling, curation, and annotation in dental AI
• Emphasis on validation, bias control, and patient/end-user documentation
• Lays the foundation for scalable, trustworthy AI/AuI-enabled dental diagnostics

Access the full standard:View EN ISO 18374:2025 on iTeh Standards

Common Themes and Industry Trends

A review of May 2025’s standards reveals one of the sector’s most cross-cutting motifs: the fusion of digital transformation with foundational health care safety and accessibility. The application of AI in dentistry (EN ISO 18374) sits at the intersection of technological advancement and patient-centered outcomes, while EN 17999 reflects a growing societal emphasis on empowering independent living regardless of age or ability. Meanwhile, standards such as ISO 1135-5 and EN ISO 15883-7 reinforce time-tested imperatives of transfusion safety and infection control—but with updated methodologies and a tighter integration with global regulations.

A notable trend is the harmonization of standards for global trade (as with ISO 19842 for Dioscorea opposita rhizome), reflecting the worldwide movement toward unified health product quality. There’s also a discernible shift toward full-lifecycle management of medical products—requiring ongoing validation, post-repair requalification, and end-to-end traceability.

Compliance and Implementation Considerations

For organizations affected by these standards, careful review and prioritization are paramount:

1. Assess Scope and Applicability: Determine which standards directly impact your operations (e.g., device manufacturing, health facility operations, product import/export, AI software development).
2. Gap Analysis: Compare current procedures and products against new or revised standard requirements, identifying areas needing update (e.g., biological risk assessment, labeling, data handling).
3. Implementation Timeline: For regulatory standards with EU MDR compliance implications (e.g., EN ISO 15883-7), align implementation with transition deadlines and regional notification periods.
4. Training and Documentation: Educate staff and partners on new requirements—particularly for standards introducing new methodologies or technical vocabularies—and update documentation and records accordingly.
5. Utilize Reference Materials: Leverage normative references and harmonized standards cited within each document for detailed compliance pathways.

Resources are available at iTeh Standards for downloading full texts, accessing updates, and monitoring sector-specific changes.

Conclusion: Key Takeaways from May 2025

May 2025 was marked by a portfolio of standards solidifying the Health Care Technology sector’s commitment to safer transfusion practices, robust infection control, accessible environments, AI-enhanced health diagnostics, and the quality assurance of traditional medicines. Professionals and organizations must proactively review each applicable standard, incorporate new requirements into practice, and prioritize training and systems upgrades as needed.

Staying abreast of these evolving standards is more than a compliance task—it’s an investment in future-ready, patient-centered, and globally competitive care. Explore these standards in depth at iTeh Standards to ensure your organization remains aligned with best practices and regulatory imperatives.