Monthly Roundup: Health Care Technology Standards from April 2025 – Part 2

Looking back at April 2025, the Health Care Technology sector saw continued advancement in standardization efforts, with a notable set of five essential standards released addressing the needs of varied subsectors. This installment, as Part 2 in our three-part recap series, highlights the rigorous updates and new guidance provided in areas spanning ophthalmic optics, advanced medical radiotherapy technology, assistive mobility devices, respiratory care, and dental device regulation. Each standard contributes to building a more robust, interoperable, and safe landscape for global health care technologies—a priority for industry professionals committed to quality and compliance.

Staying informed about recently published standards is indispensable for professionals involved in product development, clinical procurement, regulatory affairs, and quality management. This overview not only catalogs what was published, but interprets why these standards are timely and relevant, and how they fit together to shape the trajectory of modern health care technology.

Monthly Overview: April 2025

April 2025 marked a dynamic period for the international standardization of health care technologies. Five key documents were published, representing a blend of substantial technical revisions and new clarifications. The month's standards show strong attention toward product safety, performance clarity, and regulatory coherence—core themes that correspond with contemporary priorities like patient safety, interoperability, and global regulatory harmonization.

This month, emphasis was placed on:

• Reinforcing baseline safety and performance of medical devices and accessories.
• Updating essential terminology in fast-evolving and high-stakes medical fields (e.g., ventilatory support).
• Enhancing guidelines for regulatory compliance, reflecting the EU MDR and global market expectations.
• Aligning test methods for electromagnetic compatibility in mobility aids for accessibility technology.
• Refreshing optical device requirements to match emerging technologies and patient needs.

Publication patterns for April 2025 reflect both an evolution in standards previously updated years ago and the introduction of first editions targeting new technical or regulatory challenges. The industry trajectory reveals not only a commitment to technological safety but also a drive towards universal language and technical understanding to support connected, safe, and effective health care delivery.

Standards Published This Month

ISO 14889:2025 - Ophthalmic Optics — Spectacle Lenses — Fundamental Requirements for Uncut Finished Lenses

Ophthalmic optics — Spectacle lenses — Fundamental requirements for uncut finished lenses

This fourth edition of ISO 14889 establishes fundamental requirements for uncut finished spectacle lenses, aiming to ensure a universal baseline for their performance, safety, and marking. Notably, the standard supersedes any conflicting requirements in related standards, reinforcing its position as the principal reference document for spectacle lens manufacturers.

ISO 14889:2025 details:

• Performance criteria for optical functionality and physiological compatibility,
• Design and material requirements, including updated terminology and specific mechanical strength and resistance to ignition,
• Optical transmittance, especially requirements for lenses meant for driving,
• Mechanical test methods and resistance to ignition procedures,
• Identification and labeling information to support traceability and regulatory compliance.

Key players:

• Manufacturers and suppliers of ophthalmic spectacle lenses,
• Regulatory bodies and quality assurance teams in optics,
• Procurement units in eye care and optical retail.

Notable revisions in this edition include modernization of dated references, editorial updates, an updated Figure 1, and a shift in terminology from "inflammability" to "resistance to ignition."

Key highlights:

• Defines baseline mechanical and optical quality for uncut spectacle lenses
• Updates requirements for automobile and road safety applications
• Modernized terminology and updated test procedures for ignition resistance

Access the full standard:View ISO 14889:2025 on iTeh Standards

EN IEC 60601-2-68:2025 - Medical Electrical Equipment – X-ray-Based Image-Guided Radiotherapy Equipment

Medical electrical equipment - Part 2-68: Particular requirements for the basic safety and essential performance of X-ray-based image-guided radiotherapy equipment for use with electron accelerators, light ion beam therapy equipment and radionuclide beam therapy equipment

This major revision applies to the safety and essential performance of X-ray-based Image-Guided Radiotherapy (X-IGRT) equipment used in conjunction with high-energy electron accelerators, light ion beam equipment, and radionuclide therapy devices. Vital for cancer centers, radiotherapy manufacturers, and specialized clinics, this standard harmonizes with the latest editions of related IEC standards, modernizing both technical requirements and documentation practices for advanced imaging and therapy integration.

Key areas addressed:

• Safety requirements for kilovoltage (kV) and megavoltage (MV) X-ray imaging technologies used in real-time or "offline" guidance,
• Communication protocols between external beam therapy equipment and imaging arrays,
• Updated mechanical and radiation hazard mitigation provisions,
• Enhanced guidance for programmable systems (PEMS), documentation, and remote operations of therapy equipment,
• Practical application instructions for users, maintainers, and inspectors in line with the latest regulatory guidance.

This edition is especially significant as it:

• Clarifies the integration and use of X-ray equipment with CT scanners, radiography, and radioscopy in therapy environments,
• Avoids redundant testing by permitting test evidence from other compliant manufacturers,
• Introduces contemporary alignment with recognized auxiliary standards (IEC 60601-2-1, -2-44, -2-64, etc.),
• Addresses operator interaction with automated correction systems for safety assurance.

Key highlights:

• Aligns radiotherapy imaging equipment safety with latest global safety requirements
• Integrates new technical and operational requirements, including for remote operation
• Minimizes redundant testing, reducing compliance costs

Access the full standard:View EN IEC 60601-2-68:2025 on iTeh Standards

ISO 7176-21:2025 - Wheelchairs – Electromagnetic Compatibility for Powered Wheelchairs and Battery Chargers

Wheelchairs — Part 21: Requirements and test methods for electromagnetic compatibility of electrically powered wheelchairs and scooters, and battery chargers

ISO 7176-21:2025 provides robust requirements and standardized test procedures for electromagnetic emissions and immunity in powered wheelchairs, scooters, and their battery chargers. This is critical for ensuring the safety, accessibility, and operational reliability of mobility aids, especially for users in diverse and technologically complex environments.

Core elements include:

• Clear definitions for different types of mobility aids (powered, manual with power add-ons, etc.),
• Emission and immunity profiles for both indoor and outdoor environments,
• Mains terminal disturbance thresholds, radiated emission and immunity limits, and test apparatus guidance,
• Guidance for comparison of test results across product variants (reference configurations),
• Coverage of on-board and off-board battery chargers, ensuring compatibility with modern power infrastructure.

Target groups:

• Manufacturers and suppliers of powered mobility aids and charging systems,
• Compliance engineers and test laboratories,
• Disability services procurement specialists and standards auditors.

This edition features updated test levels to align with the environments of intended use and harmonization with IEC 60601-1-2 standards.

Key highlights:

• Strengthens reliability and safety of powered wheelchairs in complex environments
• Standardizes EMC testing, covering emissions and immunity for both vehicles and chargers
• Provides configurations and reporting requirements for consistent compliance validation

Access the full standard:View ISO 7176-21:2025 on iTeh Standards

ISO 19223-2:2025 - Lung Ventilators and Related Equipment – High Frequency and Jet Ventilation Vocabulary

Lung ventilators and related equipment — Vocabulary and semantics — Part 2: High frequency and jet ventilation

The second part of the ISO 19223 series addresses the nuanced vocabulary for high-frequency and jet ventilation technologies, targeting both technical standards writers and health informatics professionals. This document plays a foundational role in harmonizing the terminology across lung ventilator devices, clinical documentation, device interoperability, and regulatory labeling.

Coverage includes:

• Definitions and semantics for major high-frequency modalities (HFOV, HFPV, HFJV, and combined modes),
• Critical terms for frequencies, waveform, pressures, and ventilatory cycles,
• Use cases spanning device standards, EHRs, data reporting, and adverse event tracking,
• Applicability to device labeling, user manuals, and interoperability frameworks.

Stakeholders:

• Ventilator manufacturers and software developers,
• Respiratory care engineers, clinicians, and health informatics teams,
• Regulatory specialists reviewing device documentation and compliance.

By formalizing terminology, ISO 19223-2:2025 mitigates confusion between devices, minimizes clinical risk from terminology inconsistencies, and facilitates safer patient care transfers between device platforms.

Key highlights:

• Delivers up-to-date, authoritative vocabulary for high-frequency and jet ventilation
• Supports clinical interoperability and device communication
• Essential for regulatory submissions, labeling, and adverse event reporting

Access the full standard:View ISO 19223-2:2025 on iTeh Standards

CEN/TR 12401:2025 - Dentistry – Guidance on the Classification of Dental Devices and Accessories

Dentistry - Guidance on the classification of dental devices and accessories

This updated technical report, prepared by CEN, provides comprehensive guidance on dental device classification in line with the European Medical Device Regulation (EU) 2017/745. CEN/TR 12401:2025 is an indispensable reference for manufacturers, notified bodies, and competent authorities involved with dental materials, devices, and accessories.

Key features include:

• Application of MDR classification rules to a wide range of dental products, from invasive implants to consumables and equipment,
• Updated tables reflecting current device classes and intended uses,
• Clarification of boundaries for custom-made devices and classification disputes,
• Reference to current guidance from the Medical Device Coordination Group (MDCG 2021-24),
• Explicit classification principles for modern and legacy dental technologies.

The standard is particularly valuable for manufacturers preparing regulatory submissions for the EU market and those involved in the design and innovation of dental care products.

Key highlights:

• Aligns dental device classification guidance with EU MDR (2017/745)
• Provides extensive tabulated examples for dental product classes
• Supports manufacturers and notified bodies in regulatory decision-making

Access the full standard:View CEN/TR 12401:2025 on iTeh Standards

Common Themes and Industry Trends

A review of April 2025’s standards activity reveals several cross-cutting trends:

• Regulatory Harmonization and Clarity: Many of this month's publications, notably CEN/TR 12401:2025 and ISO 14889:2025, focus on aligning technical requirements and device classification frameworks with global and European regulatory mandates. This indicates industry commitment to streamlining global market access and reducing ambiguity for manufacturers.

• Patient and User Safety at the Forefront: Safety considerations permeate EN IEC 60601-2-68:2025 and ISO 7176-21:2025, addressing both the complexity of advanced therapy modalities and the day-to-day reliability of mobility aids.

• Support for Interoperability and Data Consistency: The new vocabulary standard for lung ventilation (ISO 19223-2:2025) responds to a pressing need for universal communication—vital for health informatics, device interoperability, and clinical research.

• Technological Adaptation: Both medical electrical equipment (EN IEC 60601-2-68:2025) and assistive technologies (ISO 7176-21:2025) are seeing test procedures, documentation, and definitions updated to reflect rapidly-advancing clinical and technical realities, from remote control of equipment to compatibility of home and clinical devices.

• Sectoral Breadth: This month’s standards serve a wide swath of disciplines, from high-tech radiology and respiratory care through to ophthalmics and dental medicine—emphasizing the interconnected fabric of modern health care technology regulation.

Compliance and Implementation Considerations

Organizations affected by these standards should prioritize a structured approach to implementation:

1. Gap Assessment: Conduct an inventory review to determine where current practices, product designs, or documentation deviate from the new requirements.
2. Training: Ensure that technical and regulatory teams are familiar with new testing procedures (e.g., EMC for wheelchairs), vocabulary (e.g., ventilator terminology), and labeling obligations.
3. Supplier Communication: Where products rely on third-party certification or subsystems (e.g., imaging arrays, battery chargers), update supplier requirements and gather current compliance evidence.
4. Regulatory Strategy: For devices marketed in the EU, especially in dental, align all submissions and technical documentation to reflect the new MDR-linked guidance (CEN/TR 12401:2025).
5. Timeline: Note effective and transition dates, especially for standards superseding previous versions. For instance, EN IEC 60601-2-68:2025 may have a phased withdrawal of earlier editions.
6. Cross-functional Coordination: Collaborate with clinical, engineering, and procurement teams to update specifications, processes, and user instructions where new standard language or requirements must appear.

Resources such as training seminars, compliance workshops, and standards interpretation guides can accelerate readiness for adoption.

Conclusion: Key Takeaways from April 2025

This month’s standards activity underscores the multifaceted challenge faced by the Health Care Technology sector in harmonizing safety, innovation, and regulatory compliance. Some of the most impactful developments included:

• The definitive update to spectacle lens requirements (ISO 14889:2025), strengthening quality benchmarks in ophthalmics.
• Major leaps in radiotherapy device safety and harmonization (EN IEC 60601-2-68:2025).
• Furthering accessibility and inclusivity in mobility aids with clear EMC guidelines (ISO 7176-21:2025).
• A universal language for high-frequency ventilation, supporting clinical safety and device interoperability (ISO 19223-2:2025).
• Clear, up-to-date dental device classification guidance aligned to the latest EU regulations (CEN/TR 12401:2025).

For professionals in health care technology—whether you are overseeing product development, ensuring procurement compliance, or navigating the intricacies of international regulation—remaining proactive in standards adoption is essential. Exploring each standard in detail, via resources such as iTeh Standards (standards.iteh.ai), will position your organization at the forefront of quality, safety, and market readiness in an ever-evolving global health care landscape.