Health Care Standards Summary - October 2025 (Part 2)

Looking back at October 2025, the Health Care sector saw the publication of several significant standards that directly impact clinical practice, infection prevention, the quality of medicinal products, and device engineering. This second part of our comprehensive monthly overview focuses on five pivotal standards, including crucial updates on medical supply units, dental instruments, and natural medicine constituents. Industry professionals, quality managers, compliance officers, and researchers will find this retrospective analysis valuable for understanding how these documents shape current industry requirements and future direction.

Monthly Overview: October 2025

October 2025 manifested a strong focus on both traditional and contemporary aspects of Health Care standardization. The harmonization and rigor of specifications for medical equipment, natural products, and disinfection processes stood out as central themes. Notably, this period continued to reflect growing international emphasis on:

• Patient and provider safety for medical and dental devices
• Ensuring efficacy and traceability in disinfection processes
• Standardization of the quality and safety of traditional medicinal plant materials

Compared to previous months, October highlighted a balance between updates to established device standards (e.g., medical supply units, dental hand tools) and comprehensive guidance for the safety of herbal products in global supply. By examining revisions, expansions, and entirely new standards, we observe a regulatory landscape that is converging towards integrated safety, performance assurance, and globalization of health care practices.

Standards Published This Month

prEN ISO 11197 - Medical supply units (ISO/DIS 11197:2024)

Medical supply units (ISO/DIS 11197:2024)

This standard provides comprehensive requirements for the basic safety and essential performance of medical supply units—the containment systems and enclosures that deliver gas, power, and data to patient care areas in all types of healthcare facilities. prEN ISO 11197 applies both to factory-manufactured and on-site assembled units, clarifying that those who assemble such infrastructure on-site assume full manufacturing responsibility.

Among the highlights are expansions relating to safety in both temporary and permanent installations—an important consideration learned from recent emergency medical deployments—and detailed requirements for anti-static hose applications within supply units. The document aligns with IEC 60601-1:2005+A1:2012 and integrates specifications for identification, marking, testing, mechanical, electrical, and radiation hazard protection. Of particular relevance to regulatory affairs and procurement teams, the standard underscores the importance of cross-reading collateral and particular standards for comprehensive compliance.

Key highlights:

• Applicability to all medical supply units, regardless of assembly method
• Expanded guidance for transition from temporary to permanent installations
• New requirements for anti-static hoses and scope gap resolution against IEC 60601-1:2012

Access the full standard:View prEN ISO 11197 on iTeh Standards

ISO 24049:2025 - Traditional Chinese medicine - Aconitum carmichaelii parent root tuber

Traditional Chinese medicine — Aconitum carmichaelii parent root tuber

ISO 24049:2025 sets minimum quality and safety requirements for Aconitum carmichaelii parent root tuber, a vital yet high-toxicity herbal material in traditional Chinese medicine (TCM). The standard encompasses roots used in both raw medicinal material form and as decoction pieces in global trade, responding to the ongoing challenge of toxicity management and adulteration in herbal markets.

It details the necessary morphological, macroscopic, and microscopic characteristics for authenticity, and establishes limits for moisture, total ash, acid-insoluble ash, heavy metals, pesticide residues, and specific marker alkaloids such as aconitine and hypaconitine. Sampling and laboratory test methods are prescribed to ensure reliable, reproducible results. The annexes discuss global implementation and the necessity for harmonized controls to mitigate the notorious toxicity risks associated with Aconitum products—a topic of frequent concern in international pharmacovigilance.

Key highlights:

• Internationally harmonized quality and safety controls for a high-risk medicinal herb
• Defined test methods for contaminants and active marker compounds
• Guidance helps prevent market entry of substandard or adulterated materials

Access the full standard:View ISO 24049:2025 on iTeh Standards

ISO 15087:2025 - Dentistry - Dental elevators

Dentistry — Dental elevators

This international standard consolidates and expands technical requirements for metallic dental elevators, key instruments in oral surgery for loosening or extracting teeth or tooth roots. ISO 15087:2025 merges several previous part standards into a single, harmonized document. It specifies material and dimensional requirements for common types (e.g., Warwick James, Cryer, Coupland, Bein, and Flohr elevators), test methods for mechanical properties, and surface finish criteria to minimize infection risk.

Of distinct practical importance are requirements for reprocessing and the integrity of hollow-handled designs, including both hydrostatic and ultrasonic leak tests. This ensures both clinical reliability and effective sterilization cycles—an important aspect for compliance managers monitoring infection prevention standards. Marking, labeling, and packaging provisions facilitate instrument traceability and user safety.

Key highlights:

• Consolidation of all major metallic dental elevator types into a single standard
• New requirements for device reprocessing and hollow-handle leakage
• Rigorous dimensional and material performance testing for patient safety

Access the full standard:View ISO 15087:2025 on iTeh Standards

EN 16616:2022+A1:2025 - Chemical disinfectants and antiseptics - Chemical-thermal textile disinfection

Chemical disinfectants and antiseptics — Chemical-thermal textile disinfection — Test method and requirements (phase 2, step 2)

This European standard outlines a laboratory-based, phase 2, step 2 carrier test for chemical-thermal disinfection of textiles—crucial for infection risk reduction in healthcare, social care, and community facilities. EN 16616:2022+A1:2025 establishes criteria for microbicidal efficacy using washing machine processes, simulating real-world use in hospitals, dental clinics, schools, nursing homes, and other institutional settings.

Updated in 2025 with improved procedural harmonization and clarity, the standard fixes minimum benchmarks for product activity and details lab procedures including organism selection, test conditions, and evaluation metrics. It also provides guidance for neutralizer selection, reporting, and verification of repeatability. Its alignment with related standards such as EN 14885 enables a coherent suite of test references for disinfectant manufacturers and service providers.

Key highlights:

• Revised carrier test method for microbicidal activity in textile disinfection
• Explicit requirements for process parameters in institutional and healthcare environments
• Harmonization with other European microbicidal test protocols

Access the full standard:View EN 16616:2022+A1:2025 on iTeh Standards

ISO 19047:2025 - Traditional Chinese Medicine - Polygonum multiflorum root

Traditional Chinese Medicine — Polygonum multiflorum root

ISO 19047:2025 provides a unified international reference for the quality and safety of Polygonum multiflorum root (Heshouwu), a widely used ingredient in Chinese materia medica that has faced international concerns due to potential hepatotoxicity. The standard covers requirements for both raw and processed roots in international trade, including morphological and microscopic identification, as well as laboratory analysis for markers such as 2,3,5,4'-tetrahydroxystilbene-2-O-β-D-glucoside.

Specifications address moisture content, ash values, extractives, heavy metal and pesticide residue levels, and packaging/labeling requirements. Test methods are detailed for each parameter to ensure consistency in assessment across borders, with annexes providing information for national adaptation. For manufacturers and importers, this means clearer, universally accepted guidance for product quality claims and documentation.

Key highlights:

• Universal quality standardization for a popular but high-scrutiny herbal medicine
• Defined protocols for authenticity, safety, and heavy metal/pesticide monitoring
• Guidance supports fair trade and regulatory due diligence in herbal product supply chains

Access the full standard:View ISO 19047:2025 on iTeh Standards

Common Themes and Industry Trends

Analyzing these five standards together reveals several important patterns in October 2025's Health Care standardization efforts:

• Safety and performance remain fundamental objectives, with detailed requirements for equipment design, construction, and routine use.
• International harmonization of herbal medicinal product standards is accelerating, reflecting the globalization of the supply chain and rising expectations for rigorous quality assurance across borders.
• Infection prevention and control continues to be refined, with evolving protocols for device reprocessing, environmental/linen disinfection, and marking/traceability procedures.
• Both device-related and non-device-related standards now emphasize robust test methods and repeatable reporting structures, facilitating regulatory scrutiny and supporting post-market surveillance.
• Greater alignment between device engineering and product use-context is evident, particularly for solutions intended for both routine and emergency operations (as with medical supply units and infection prevention protocols).

Sector-specific priorities are echoed by the increased specificity in requirements for the performance, identification, and documentation of both manufactured products and natural substances. The prevalence of standards for traditional Chinese medicines reflects both broadening international trade and rising public health vigilance concerning product safety.

Compliance and Implementation Considerations

Organizations impacted by these standards should consider the following steps in their compliance planning:

1. Gap Assessment
   • Conduct an inventory of current products, processes, and documentation against the requirements in each standard.
2. Stakeholder Education
   • Engage engineering, procurement, quality, and clinical staff in training on updated requirements, especially for revised test protocols, packaging, and labeling instructions.
3. Implementation Timeline
   • Factor in publication and transition periods noted in national or regional adoptions, as well as coordination with suppliers—particularly for herbal ingredients that may be sourced globally.
4. Documentation and Traceability
   • Ensure devices and herbal products are properly marked, and test results are verifiable, to support both regulatory audits and internal quality assurance systems.
5. Resources
   • Utilize the full text of each standard (reference links provided above) and participate in sector webinars, workshops, or user groups facilitated by professional societies and standards bodies.
   • Consider subscribing to standards update services to stay abreast of future amendments and revisions.

Conclusion: Key Takeaways from October 2025

October 2025 was a pivotal month showcasing the continual evolution of standards in the Health Care sector. Major advances were seen in the codification of requirements for medical supply infrastructure, hygiene technologies, and the robust regulation of traditional Chinese medicinal materials. For professionals charged with ensuring quality and compliance, these publications offer authoritative benchmarks for both operational excellence and regulatory conformity.

Staying informed and agile in response to emerging standards is essential for safeguarding clinical quality, supporting innovation, and maintaining market access in a globalized environment. Explore each standard in detail to ensure that your organization’s products and practices reflect the very latest in safety, performance, and best practice guidance.

For further exploration and access to the complete documents, visit iTeh Standards: https://standards.iteh.ai