Health Care Technology Standards Summary – July 2025

Looking back at July 2025, the health care technology sector witnessed the publication of an updated international standard with significant implications for dental device manufacturing and practice. Only one standard—ISO 18397:2025 Dentistry – Powered scalers—was published for the month in this category, but its breadth and depth underscore important trends in clinical safety, instrument performance, and regulatory compliance. For professionals, compliance officers, and procurement specialists who may have missed this revision, this comprehensive overview unpacks the nuances and practical impacts of this key development.

Monthly Overview: July 2025

During July 2025, standardization activity in the health care technology sector, particularly dentistry, centered on updating requirements for powered scalers. This focused publication pattern continued the recent trend of refining device-specific standards in an evolving landscape marked by advanced instrument technology, patient safety prioritization, and usability enhancements. Compared to more active months characterized by broader publication across several subfields, this single but substantial update reflects the dental profession’s ongoing drive for harmonized global requirements and process improvements. The revised standard crystallizes a growing emphasis on safety, durability, practical usability, and clear guidance for manufacturers.

ISO 18397:2025’s comprehensive update also speaks to an industry-wide response to increased regulatory scrutiny, the need for interoperability with modern dental units, and growing demand for patient-centered care. For clinicians, manufacturers, and regulators, this update represents both a refined baseline and a springboard for ongoing technological innovations in dental health care technology.

Standards Published This Month

ISO 18397:2025 - Dentistry – Powered scalers

Dentistry – Powered scalers

ISO 18397:2025 sets forth rigorous requirements and test methods for air-powered and electrical-powered scaler handpieces and scaler tips—including both piezoelectric and magnetostrictive ultrasonic scalers. The scope includes stand-alone devices and those designed for connection to comprehensive dental units. The standard details material integrity, mechanical durability, noise level limitations, electromagnetic compatibility, user instructions, and marking and packaging criteria applicable to the manufacture and safe clinical use of powered scalers.

The standard covers:

• Classification of scaler handpieces by frequency types
• Detailed performance requirements for device components (e.g., drop resistance, output power, vibration limits, breakage resistance)
• Stringent test protocols for handpiece and tip connections (insertion and extraction forces, holding torque, and tightening torque)
• Examination of safety aspects such as noise levels, excessive temperature prevention, electromagnetic compatibility, and resistance to water ingress
• Guidance on manufacturers’ instructions related to installation, operation, maintenance, servicing, and critical safety information
• Marking, labelling, and packaging protocols to support traceability and correct use

This second edition notably replaces ISO 18397:2016. The revision introduced several important changes:

• Adaptation of designation for scaler tips to improve clarity and consistency
• Reduced maximum operating frequency for air-powered scaler handpieces, reflecting ergonomic and patient safety assessments
• Requirement for instructions to include output power in relevant devices
• Simplified amplitude limit value description for practical adoption and compliance

Who needs to comply:

• Dental scaler and dental unit manufacturers
• Dental device design and quality assurance teams
• Regulatory authorities overseeing dental equipment
• Clinical dental practitioners and procurement officers responsible for equipment selection

Fit into regulatory landscape: ISO 18397:2025 harmonizes requirements across international markets, referencing foundational ISO and IEC standards for medical devices (e.g., ISO 10993-1 for biological evaluation, IEC 60601-1 for medical electrical equipment, and others focused on graphical symbols, mechanical safety, electromagnetic compatibility, and usability). Its role is especially important in supporting national and regional regulatory submissions and post-market surveillance.

Key highlights:

• Expanded classifications and requirements for both air-powered and electrical-powered scaler handpieces and tips
• Tighter limits and revised test methods for output power, vibrational exposure, and temperature rise
• Enhanced instructions, marking, and packaging specifications for clinical safety and post-market traceability

Access the full standard:View ISO 18397:2025 on iTeh Standards

Common Themes and Industry Trends

July 2025’s standardization activity, while limited in quantity, signals several clear themes shaping dental technology:

• Patient Safety and Device Usability: Expanded requirements for temperature control, vibration minimization, and electromagnetic compatibility reflect heightened attention to patient and operator safety. Usability clauses echo a growing trend in health care—devices must not only be effective but user-friendly and predictable in real-world settings.

• Harmonized Testing and Compliance: By referencing a comprehensive array of ISO and IEC standards, ISO 18397:2025 helps unify global testing and compliance expectations. This harmonization benefits multinational device manufacturers and dental practices operating across borders.

• Supporting Innovation and Modernization: New limits for frequency, power, and amplitude account for contemporary clinical realities, allowing for technical advances (such as sophisticated handpiece designs) to be used safely and efficiently.

• Comprehensive Instructions and Lifecycle Guidance: The mandate for more detailed manufacturer instructions, enhanced marking, and thorough packaging requirements highlights the sector’s evolving position on the visibility of safety and compliance data throughout the product lifecycle.

This publication upholds trends seen across recent health care technology standards—including the prioritization of risk management, human factors engineering, and robust traceability throughout supply and usage chains.

Compliance and Implementation Considerations

For organizations affected by ISO 18397:2025, the following practical steps and recommendations are paramount:

• Early Assessment: Technical, quality, and regulatory teams should review the new requirements and compare them against existing processes, device designs, and documentation. Particular focus should be placed on new or revised test methods for output power, frequency, amplitude, and mechanical durability.

• Supplier Engagement: Manufacturers and procurement specialists should confirm that upstream suppliers of scaler tips, handpiece assemblies, and packaging materials understand and implement all updated requirements.

• Documentation Updates: Revise all user instructions, maintenance/service guidelines, and marking/labelling materials to conform to the enhanced standard. Ensure output power values and classifications are accurately reflected.

• Timeline Management: While the standard came into effect in July 2025, organizations should prioritize updates to models intended for future production or market expansion. For legacy products, review whether retrofitting or enhanced instructions are necessary for continued regulatory compliance.

• Training and Resources: Offer targeted staff training—especially for clinical, technical service, and compliance personnel—on handling, maintenance, and validation protocols aligned with the standard’s requirements.

For detailed guidance and access to the standard’s full text, professionals should reference:

View ISO 18397:2025 on iTeh Standards

Conclusion: Key Takeaways from July 2025

The retrospective examination of July 2025 reveals ISO 18397:2025 as the central standard published for health care technology within the dental field. Although only one document was published in this period, its comprehensive revisions set a benchmark for safety, performance, and user guidance in powered scalers—key devices in preventive and therapeutic dental care.

Implications for professionals:

• Device manufacturers, quality managers, and regulatory teams should prioritize understanding and applying the updated requirements.
• Procurement specialists and clinicians must ensure their equipment acquisition strategies recognize and demand compliance with this revised benchmark.
• Staying current with evolving standards, such as ISO 18397:2025, enhances not only operational safety and regulatory standing but also long-term trust with patients and professional partners.

Continued monitoring of standardization activity, such as that available on iTeh Standards, is essential for staying ahead in health care technology compliance and innovation.

Explore ISO 18397:2025 and other health care technology standards at:iTeh Standards