May 2025 in Review: HEALTH CARE TECHNOLOGY Standards Overview (Part 1 of 3)

Looking back at May 2025, the health care technology sector was marked by the publication of several influential standards. These documents reflect a continued commitment to innovation, patient safety, and enhanced device performance. This article—Part 1 of a three-part monthly retrospective—surveys five new standards, each shaping contemporary practice and compliance. For professionals who need to stay aligned with regulatory changes and technological advancements, this overview distills the key requirements, context, and trends evident in these publications, offering practical guidance for immediate and future implementation.

Monthly Overview: May 2025

May 2025 proved to be a significant period for health care technology standards. The month saw a balanced focus on both device innovation (such as absorbable metallic implants) and practical clinical solutions (dental cements and ophthalmic diagnostics). Standards published in this period continue the trend of reinforcing rigorous material science, emphasizing biocompatibility, and clarifying performance expectations across a spectrum of medical and dental applications.

Compared to previous months, May 2025 exhibited an upturn in standards relating to the interface between advanced materials, patient contact devices, and specialized connectors for critical therapies. This aligns with the broader industry’s push for improved safety, reliability, and traceability—crucial for organizations facing evolving regulatory scrutiny and the demands of modern clinical environments.

Standards Published This Month

ISO/TS 20721:2025 – Implants for Surgery – Absorbable Implants

Implants for surgery – Absorbable implants – General guidelines and requirements for assessment of absorbable metallic implants

ISO/TS 20721:2025 sets out general principles and best practices for evaluating the performance of absorbable metallic implants. Recognizing that these implants, unlike traditional permanent devices, are designed to degrade and be fully absorbed by the host, the standard provides special considerations for materials selection, in vitro degradation and fatigue tests, and biocompatibility evaluation. Guidance covers metals such as magnesium, iron, and zinc and notes important distinctions from non-absorbable counterparts—including the need to assess degradation products.

For manufacturers and material suppliers in the surgical implant industry, compliance with this standard is essential to ensure reliable, safe absorption of implanted devices, avoid misleading test outcomes, and meet current regulatory requirements. The standard incorporates references to related ASTM and ISO documents, specifying both metallurgical and biological evaluation benchmarks. It does not address application-specific requirements or non-metallic components that may be present with the implant.

Key highlights:

• Introduces recognized evaluation methods specific to absorbable metals, differentiating them from permanent implants
• Stresses thorough in vitro and in vivo characterization, including biocompatibility of degradation products
• Promotes harmonization with referenced ASTM standards and ISO biological evaluation guidelines

Access the full standard:View ISO/TS 20721:2025 on iTeh Standards

ISO 9917-1:2025 – Dentistry – Water-Based Cements (Part 1)

Dentistry – Water-based cements – Part 1: Acid-base cements

The third edition of ISO 9917-1:2025 provides comprehensive requirements and testing protocols for acid-base dental cements, used in permanent cementation, lining, and restoration. This standard applies to both hand-mixed and mechanically-mixed (encapsulated) cements but specifically excludes resin-modified water-based cements. The document details strict performance properties—setting time, compressive strength, acid erosion, radiopacity, and content of toxic elements (arsenic and lead)—tailored to each specific application, such as luting, base or liner, or pit and fissure sealing.

Manufacturers and quality managers in dental materials must adhere closely to these updated protocols to ensure safety, clinical efficacy, and compliance with international trade. With refinements over previous editions, the standard now includes pit and fissure sealants in scope, adopts updated radiopacity test methods, and reinforces transparent labeling and component declarations.

Key highlights:

• Updated scope covering pit and fissure sealing cements and new application-based requirements
• Defines detailed test methods (setting time, strength, acid resistance)
• Adds requirements for packaging, marking, and component declaration

Access the full standard:View ISO 9917-1:2025 on iTeh Standards

ISO 9917-1:2025 – Dentistry – Water-Based Cements (Duplicate Entry)

Dentistry – Water-based cements – Part 1: Acid-base cements (See previous entry. Standard appears twice in this period, emphasizing its relevance across multiple use cases.)

Access the full standard:View ISO 9917-1:2025 on iTeh Standards

ISO 5868:2025 – Ophthalmic Optics and Instruments – Anomaloscopes

Ophthalmic optics and instruments – Anomaloscopes for the diagnosis of red-green colour vision deficiencies

ISO 5868:2025 addresses the design and performance requirements for anomaloscopes—devices critical for diagnosing red-green color vision deficiencies by measuring an individual’s ability to match a red-green light mixture to yellow. The standard sets optical, spectral, and technical parameters (such as chromaticity, luminance, and step size) to ensure diagnostic consistency regardless of device brand or technical variation.

Clinical practitioners, diagnostic laboratories, and manufacturers of ophthalmic instrumentation are direct stakeholders. This standard provides assurance that diagnostic outcomes are physiologically relevant and comparable, fulfilling occupational and clinical screening requirements internationally. It references CIE colorimetry standards and incorporates methodologies for conformity assessment and uncertainty calculation.

Key highlights:

• Standardizes anomaloscope performance to ensure reliable quantification of red-green color deficiencies
• Requirements ensure measured values are device-independent and physiologically correlated
• Advances consistency in occupational and clinical screening protocols

Access the full standard:View ISO 5868:2025 on iTeh Standards

ISO 80369-6:2025 – Small Bore Connectors for Neural Applications

Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neural applications

ISO 80369-6:2025 delineates requirements for small-bore connectors designed for neural applications—procedures involving delivery or removal of fluids to/from neural sites (such as the spine or brain ventricles), including regional anesthesia and diagnostic sampling. The standard seeks to minimize the risk of misconnections (a leading patient safety issue) by specifying non-interlockable design features, dimensional tolerances, and rigorous materials tests.

Manufacturers of medical devices for neural therapies, anesthesia, and neuro-monitoring devices must ensure that connectors conform to these precise parameters. The update emphasizes inclusivity in terminology and incorporates modifications for broad regulatory acceptance, such as changes in terminology and harmonized test protocols across the ISO 80369 series.

Key highlights:

• Establishes connector design and performance requirements to prevent misconnections
• Updates material, performance, and testing protocols for neural application safety
• Aligns with broader ISO 80369 series to promote international interoperability

Access the full standard:View ISO 80369-6:2025 on iTeh Standards

Common Themes and Industry Trends

A retrospective analysis of the standards published in May 2025 in health care technology reveals several recurring trends:

• Material science and absorption dynamics: Continued refinement of requirements for next-generation implant materials and absorbable devices demonstrates the field’s move toward personalized, less invasive medicine.
• Patient safety through performance standardization: Both dental and neural device standards reinforce the centrality of error prevention—be it by tightening product composition requirements or enforcing connector design to eliminate misconnections.
• Diagnostic accuracy: The specification for ophthalmic anomaloscopes indicates an industry-wide drive for more reliable, comparable diagnostic results, especially for occupational and clinical screenings.
• Transparent labeling and component disclosure: Several standards now require explicit documentation and labeling, facilitating traceability and informed procurement.

Collectively, these trends point to an industry preparing for ever-tightening regulatory expectations and a clinical environment that rewards innovation paired with robust risk management.

Compliance and Implementation Considerations

Given the diverse range of standards published this month, organizations across the health care technology sector should:

• Review current practices and product lines for alignment with new testing protocols, especially regarding biocompatibility, material degradation (for absorbable implants), and toxic element content in dental cements.
• Prioritize training for design and quality teams, ensuring comprehension of new connector dimensional requirements and safety protocols for neural applications.
• Plan for phased implementation, as supply chain and regulatory checks (especially for labeling and component declaration) may require adaptation time.
• Engage with suppliers early to verify that supplied components and raw materials meet updated standards.
• Leverage iTeh Standards resources to access full details, guidance, and updates, ensuring effective implementation and ongoing compliance.

For most standards, immediate compliance is expected once the publication is recognized by regulatory authorities, but transitional provisions may apply in some jurisdictions. Timely adoption demonstrates due diligence and reduces the risk of non-conformance penalties.

Conclusion: Key Takeaways from May 2025

May 2025 was a pivotal month for health care technology standardization—setting critical expectations for absorbable implants, dental materials, ophthalmic diagnostics, and neural connectors. The featured standards reflect both the sector’s increasing complexity and its ongoing dedication to safety, efficacy, and harmonization.

Professionals in the sector are encouraged to:

• Examine these new standards in detail on iTeh Standards to understand nuances and compliance pathways
• Coordinate implementation teams across procurement, quality, R&D, and compliance to facilitate smooth adoption
• Monitor emerging updates, as ongoing harmonization and evolving patient safety imperatives are likely to drive additional requirements

Remaining attuned to these developments is essential—not just for maintaining market access, but for advancing best practices in health care technology. Explore these standards in depth using the provided links, and position your organization for success amid evolving regulatory and clinical landscapes.