A Look Back: Health Care Technology Standards Published in July 2025 (Part 2)

Looking back at July 2025, the health care technology sector experienced a notable period of standardization activity, with five influential standards released. This part of our four-part monthly overview examines the newly released documents addressing the quality of herbal medicines, advancements in dental instruments, the critical safety of medical gas pipeline systems, and revised requirements for surgical implant materials. Together, these standards highlight ongoing progress in safety, efficacy, and international harmonization within health care technology. For professionals seeking to remain up to date, this retrospective provides essential context, key insights, and practical considerations from the standards published during the month.

Monthly Overview: July 2025

July 2025 witnessed a diverse set of standards shaping key segments of health care technology. The breadth of topics—from traditional herbal medicine to precision dental devices and critical infrastructure for medical gases—reflects a sector that balances innovation with the essentials of patient safety and treatment efficacy. Compared to previous months, July’s publications were characterized by the reinforcement of international alignment and the continued refinement of technical specifications, particularly in critical care and surgical applications. Coupled with updates to material standards for surgical implants, this month's outputs underscore a trend toward lifecycle quality management and interoperability—an industry direction mirroring broader global health priorities.

Standards Published This Month

ISO 19836:2025 - Traditional Chinese Medicine — Platycodon Grandiflorus Root

Traditional Chinese medicine — Platycodon grandiflorus root

This standard sets forth the minimum requirements and robust test methods for Platycodon grandiflorus root—an herbal product with long-standing use in East Asian medicine for respiratory and throat conditions. The document defines standards relevant for both raw medicinal materials and processed decoction pieces, ensuring consistency in international trade. Covered aspects include morphological and microscopic features, chromatographic identification, chemical composition thresholds (e.g., moisture, ash, extractives), and contaminant limits (such as heavy metals, pesticides, and sulfur dioxide).

By offering precise definitions and quality assessment methods, ISO 19836:2025 facilitates market access, supports regulatory compliance across jurisdictions, and enhances consumer safety.

Who needs to comply: Manufacturers, exporters, importers, regulatory authorities, and quality professionals in the herbal medicine sector.

Notably, the standard harmonizes requirements with a range of international pharmacopoeias and references best practices for sampling, packaging, and labelling—all critical for traceability and market acceptance.

Key highlights:

• Establishes comprehensive quality and safety criteria for Platycodon grandiflorus root
• Introduces unified testing protocols for global trade
• Addresses chemical, microbiological, and contaminant safety

Access the full standard:View ISO 19836:2025 on iTeh Standards

EN ISO 18397:2025 - Dentistry — Powered Scaler (ISO 18397:2025)

Dentistry — Powered scaler (ISO 18397:2025)

EN ISO 18397:2025 details the requirements and standardized test methods for powered scaler handpieces and tips—encompassing air-powered, electrical-powered, piezo, and magnetostrictive ultrasonic types found in modern dental practices. The coverage applies to both standalone units and those integrated into dental treatment centers.

The standard sets essential parameters for safety, materials selection, drop and noise testing, operational temperature, resistance to reprocessing, leakage, and electromagnetic compatibility. Detailed criteria for scaler tip performance (connection strength, torque, output power, breakage resistance) help ensure durability and patient safety. Enhanced instructions for manufacturers on marking and packaging are also mandated.

Who needs to comply: Dental device manufacturers, dental equipment suppliers, clinical quality officers, and regulatory agencies overseeing dental healthcare equipment.

With this revision, the standard reflects advances since the 2016 edition and strengthens the reliability and interoperability of dental technology across health systems.

Key highlights:

• Comprehensive safety and performance requirements for all major powered scaler types
• Enhanced focus on testable criteria for clinical safety and device longevity
• Smart updating of instructions for use, packaging, and marking

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

ISO 7396-3:2025 - Medical Gas Pipeline Systems — Part 3: Proportioning Units for the Production of Synthetic Medical Air

Medical gas pipeline systems — Part 3: Proportioning units for the production of synthetic medical air

This crucial standard specifies the requirements for the construction and operation of devices that generate synthetic medical air by blending regulated proportions of oxygen and nitrogen. These proportioning units are essential components within larger medical gas pipeline systems, supporting both patient respiratory supply and driving surgical tools.

The document details requirements for material suitability, design safety, conformity management, filtration, monitoring, alarm systems, and comprehensive testing (e.g., leakage, performance, electromagnetic compatibility). It clearly positions these proportioning units as central to systems complying with ISO 7396-1, with a tight focus on gas quality, device reliability, and procedural transparency.

Who needs to comply: Medical gas system manufacturers, hospital engineering teams, health facility managers, and regulatory officials responsible for medical gas safety.

The standard’s alignment with global safety and pharmacopoeial requirements strengthens system resilience against supply interruptions—vital in both routine and emergency settings.

Key highlights:

• Defines construction and operational criteria for synthetic medical air generators
• Stresses multi-layered safety measures, including alarms and conformance tracing
• Mandates rigorous test protocols for gas purity and system robustness

Access the full standard:View ISO 7396-3:2025 on iTeh Standards

ISO 5834-1:2025 - Implants for Surgery — Ultra-high-molecular-weight Polyethylene — Part 1: Powder Form

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 1: Powder form

This standard focuses on the requirements and test methodologies for ultra-high-molecular-weight polyethylene (UHMWPE) in powder form—the foundational raw material for manufacturing surgical implant components. It specifies material classifications, flow properties, contamination limits (ash, trace elements, particulate matter), and associated test protocols. Notably, the scope expressly excludes materials blended with additives or polyethylene variants.

Who needs to comply: Medical polymer suppliers, implant manufacturers, materials laboratories, and regulatory reviewers.

The 2025 edition marks a continued drive for purity and process control, key factors for the biocompatibility and performance of orthopaedic and other surgical implants.

Key highlights:

• Establishes clear purity and characterization parameters for UHMWPE powder
• Introduces precise test methods addressing material properties crucial for surgical use
• Reinforces traceability from raw material phase through to final device

Access the full standard:View ISO 5834-1:2025 on iTeh Standards

ISO 5834-2:2025 - Implants for Surgery — Ultra-high-molecular-weight Polyethylene — Part 2: Moulded Forms

Implants for surgery — Ultra-high-molecular-weight polyethylene — Part 2: Moulded forms

A companion to the powder form standard, ISO 5834-2:2025 covers requirements for UHMWPE in moulded form (sheets, rods, and near net shape bars) used for implant manufacturing. The document sets requirements for physical properties such as density, tensile strength, elongation, impact resistance, and particulate contamination, along with methods for test specimen preparation and certification. The standard notably excludes intentionally irradiated materials, those with additives, or blended polyethylene types, as well as finished and packaged implants.

Who needs to comply: Implant manufacturers, supply chain managers, and test laboratories collaborating on orthopaedic or medical-grade plastic devices.

This edition reflects harmonization efforts with ASTM F648-21 and integrates updated normative references, promoting international consistency for device material quality.

Key highlights:

• Defines mechanical and purity characteristics for UHMWPE moulded forms
• Aligns with updated material test standards (ASTM)
• Reinforces quality assurance from raw form to device fabrication

Access the full standard:View ISO 5834-2:2025 on iTeh Standards

Common Themes and Industry Trends

This month’s health care technology standards disclose several significant patterns:

• Quality and Traceability: Whether dealing with botanical medicines, dental implements, or implant materials, standards are increasingly codifying stringent requirements for purity, consistency, and traceability.
• Safety at Every Level: From high-precision surgical and dental devices to gas delivery infrastructure, safety is the unifying driver—manifesting as rigorous material testing, embedded monitoring/alarm systems, and robust contaminant controls.
• Harmonization and Global Trade: The standards reflect a continued push for international harmonization (e.g., alignment with pharmacopoeias and ASTM) to facilitate cross-border regulatory acceptance and smoother supply chains.
• Device Lifecycle Perspective: Recent standards emphasize not only initial manufacturing quality but also the ongoing usability, reprocessing, and maintenance needs of critical health care assets.

Finally, there is a visible alignment with global health priorities such as infection prevention, safe surgical practices, and risk mitigation for complex care environments.

Compliance and Implementation Considerations

To leverage the benefits of these new standards and ensure regulatory alignment, organizations should:

• Prioritize a Gap Assessment: Review internal processes and product portfolios against new or revised requirements, especially for device manufacturers and suppliers of herbal substances or implant materials.
• Engage Quality and Regulatory Teams: Early involvement of compliance professionals will smooth the transition to updated marking, packaging, and documentation requirements (see powered scaler and medical gas system standards).
• Plan for Test Method Upgrades: Laboratory and testing staff should align their protocols with the newly specified methods for contaminant detection, mechanical property assessment, and performance measurement.
• Set Realistic Timelines: Allow sufficient lead time for design changes, product testing, and third-party certification—particularly where recertification is mandated.
• Utilize Authoritative Resources: Access the full standards via iTeh Standards to ensure the latest technical interpretations and access critical annexes or regional differences.

Early engagement with stakeholders and suppliers will ease the transition and reduce the risk of non-compliance.

Conclusion: Key Takeaways from July 2025

The standards published during July 2025 reflect an industry committed to continual improvement in safety, efficacy, and international alignment. Particularly impactful are the advancements in requirements for botanical medicines, enhanced safety and performance criteria for dental equipment, and updated standards for medical gas and implant materials that underpin core aspects of clinical care.

Stakeholders across manufacturing, procurement, regulatory affairs, and quality management are strongly encouraged to review these standards in detail, assess their operational readiness, and update compliance strategies accordingly. Staying current is not only a matter of meeting regulatory obligations but also of driving best practice, ensuring patient safety, and maintaining market competitiveness.

Explore each standard in detail through iTeh Standards and prepare your organization and teams for the evolving landscape of health care technology.