Health Care Standards Summary – September 2025

Looking back at September 2025, the Health Care Technology sector saw the release of five significant standards, shaping the landscape of device terminology, safe practice, and materials compliance. This overview provides a comprehensive summary and analysis of this month’s publications, spanning vocabulary for respiratory care, best practices for labeling in MR environments, security protocols for high-activity radiation devices, and material requirements for surgical implants. For professionals who may have missed these updates or seek a deeper understanding of the month’s regulatory outputs, this article delivers a thorough retrospective scan of themes and compliance implications.

Monthly Overview: September 2025

September 2025 was marked by a pronounced focus on clarity, safety, and harmonization within health care technology standards. The month’s publications spanned critical domains—terminology for respiratory care devices, device and accessory safety in highly specialized environments (such as MR suites and facilities housing radioactive sources), and the specification of biomaterials for surgical implants. Compared to prior publication cycles, this set leaned strongly toward regulatory clarity and stakeholder guidance, addressing known pain points in labeling, interoperability, and risk management. The concentration of new guidance in areas such as respiratory support and radiological security also signals the industry’s ongoing adaptation to clinical, informatics, and cybersecurity challenges that are reshaping modern health care technology.

Notably, terminology harmonization for respiratory care (ISO 19223-3:2025) and specialized safety labeling (IEC 62570:2025) point to increased priorities around seamless data exchange and device usage across clinical environments. Similarly, the materials standard for unalloyed titanium in surgical implants reflects continued vigilance regarding the safety and traceability of devices in the surgical space. The cumulative impact of these standards is a more controlled, predictable, and interoperable foundation for health care devices, directly addressing regulatory and clinical demands for precision and security.

Standards Published This Month

ISO 19223-3:2025 – Vocabulary and Semantics for Respiratory Care

Lung ventilators and related equipment — Vocabulary and semantics — Part 3: Respiratory care

ISO 19223-3:2025 establishes a comprehensive vocabulary specifically targeted at respiratory care, encompassing terminology critical for high-flow therapy devices, sleep apnoea equipment, masks, and related accessories. The standard is pivotal for ensuring semantic interoperability in clinical documentation, product labeling, informatics, and electronic health records.

Its scope includes application in:

• Standards and labeling for high-flow and sleep apnoea respiratory care equipment
• Instructions for use and product documentation
• Health informatics and electronic health records
• Enhancing clarity in medical device interoperability

The exclusion of terminology for mechanical and high-frequency ventilation enables this standard to concentrate on evolving modes of respiratory support such as humidified oxygen therapy and specialized home care applications.

Key requirements address:

• Consistent use of terms for equipment, connectors, therapy modes, and functions
• Definitions for lay users versus professionals, and new device types (e.g., asymmetric nasal cannulae, data logging equipment)
• Guidance for usage in labeling, EHRs, and instructions for use

Who needs to comply:

• Device manufacturers (ventilators, CPAP/BiPAP, high-flow therapy devices)
• Software vendors (health informatics, EHRs)
• Clinical practitioners and quality managers overseeing device labeling and documentation

This standard is part of a broader shift toward digital health system integration—aligning device semantics not only for regulatory compliance but also to support interoperability in care settings and between clinical systems.

Key highlights:

• Comprehensive terminology for modern respiratory therapy
• Special focus on high-flow, sleep apnoea, and masks
• Foundation for safety, labeling, and interoperability

Access the full standard:View ISO 19223-3:2025 on iTeh Standards

IEC 62570:2025 – Marking Medical Devices for Safety in the MR Environment

Standard practice for marking medical devices and other items for safety in the magnetic resonance environment

IEC 62570:2025 standardizes best practices for marking and labeling medical devices and items expected to enter magnetic resonance (MR) environments. This is especially critical for avoiding patient and staff harm arising from misidentified equipment in areas with strong electromagnetic fields.

The document specifies:

• Correct use of terms and icons to designate items as MR Safe, MR Unsafe, or MR Conditional
• Information to be included in device and packaging labeling, including use-case scenarios and warning symbols
• Requirements for both direct product marking and package labeling where direct marking is impractical (e.g., small or implantable devices)

While mandatory portions focus strictly on items’ interaction with MR field hazards, the standard also recommends voluntary information on artifact risks and compatibility testing—aligning with contemporary approaches to risk management (e.g., ISO 14971).

Who needs to comply:

• Medical device manufacturers (all items intended for MR suite entry)
• Hospitals, imaging centers, and those in charge of clinical equipment procurement and asset management
• Quality and safety officers overseeing MR environment protocols

IEC 62570:2025’s alignment with ASTM F2503 and IEC 60601-2-33 adds to global harmonization, simplifying international device management and procurement.

Key highlights:

• Systematic marking of MR Safe, Unsafe, Conditional items
• Guidance for labeling, symbols, and user information
• Aids regulatory compliance for MR suite safety

Access the full standard:View IEC 62570:2025 on iTeh Standards

EN IEC 63322:2025 – Security of Medical Electrical Equipment with High-Activity Sealed Radioactive Sources

Security of ME equipment containing high-activity sealed radioactive sources

EN IEC 63322:2025 addresses security requirements for medical electrical (ME) equipment containing sealed radioactive sources, such as radiotherapy units and brachytherapy devices. It applies to equipment containing Category 1, 2, or 3 radioisotopes as classified by the IAEA, offering a detailed security framework for both manufacturers and organizations operating such systems.

The standard is structured around two main responsibilities:

1. Manufacturers: Must design and test equipment to meet specified physical resistance levels, document security features, conduct vulnerability assessments, and provide site security guides.
2. Responsible Organizations: Must implement suitable site and process security arrangements—including access control, intrusion detection, emergency procedures, and ongoing vulnerability assessments.

Requirements span the entire device lifecycle—from installation (insertion of the radioactive source), through daily use and storage, until final decommissioning and source removal—ensuring continuous risk mitigation.

Who needs to comply:

• Manufacturers of radiotherapy and nuclear medicine equipment
• Hospitals, clinics, and specialized centers housing radioactive devices
• Compliance and facility security management teams

This standard responds to increasing regulatory scrutiny and risk management demands around high-activity radiological sources, establishing a detailed, test-based, and auditable framework.

Key highlights:

• Categorized requirements based on IAEA source risk
• Detailed testing and risk assessment protocols
• Split responsibilities between manufacturers and operating organizations

Access the full standard:View EN IEC 63322:2025 on iTeh Standards

ISO 5832-2:2025 – Surgical Implants: Metallic Materials – Unalloyed Titanium

Implants for surgery — Metallic materials — Part 2: Unalloyed titanium

ISO 5832-2:2025 defines the chemical, structural, and mechanical property requirements for unalloyed (commercially pure) titanium used in surgical implants. It specifies six grades of titanium differentiated by tensile strength, offering clear test protocols for chemical composition, microstructure, tensile, and bending properties. This standard directly underpins the manufacturing quality and safety of critical devices such as bone plates, screws, and joint replacements.

Key changes in this new edition include:

• Updated introduction and harmonization with other parts of the ISO 5832 series
• New requirements for cobalt content to enhance material traceability and consistency
• Revised mechanical property tables for improved clarity and regulatory acceptance

Who needs to comply:

• Manufacturers of surgical implants and biomaterials
• Quality control and testing laboratories
• Procurement personnel evaluating compliant implant sources

ISO 5832-2:2025 is essential for organizations seeking conformity assessment for CE marking, FDA submissions, or tending to global market requirements. Its robust property benchmarks enable informed materials selection and ensure cross-vendor reliability for implantable devices.

Key highlights:

• Thorough chemical and mechanical tests for unalloyed titanium
• Six grades for application flexibility by tensile strength
• Enhanced alignment with global biomaterials standards

Access the full standard:View ISO 5832-2:2025 on iTeh Standards

Common Themes and Industry Trends

Several patterns emerged from the September 2025 Health Care standards publications:

• Semantic and Terminology Harmonization: ISO 19223-3:2025 exemplifies a growing trend to standardize vocabulary, an essential enabler for device interoperability and informatics integration across settings.
• Emphasis on Safety Labeling & Risk Communication: IEC 62570:2025 and EN IEC 63322:2025 both stress clear, standardized communication—whether for MR suite hazards or the security of radioactive sources.
• Lifecycle and Stakeholder Responsibility: Newer standards, particularly EN IEC 63322:2025, clarify the discrete duties of manufacturers versus operational organizations, underscoring a lifecycle approach to compliance and device security.
• Material Integrity and Regulatory Harmonization: ISO 5832-2:2025 mirrors international alignment trends, updating metallic biomaterial criteria to facilitate procurement and cross-jurisdiction marketing.

Additionally, several of the month’s standards indicate a proactive stance towards emergent threats—such as cybersecurity and unauthorized access to radiological devices—while also acknowledging the realities of integrated digital health environments and complex clinical workflows.

Compliance and Implementation Considerations

For organizations affected by these standards:

• Assessment & Gap Analysis: Conduct a standards mapping exercise against current device labeling, site protocols, and implantable material specifications to identify compliance gaps.
• Documentation Updates: Update product labeling, technical documentation, and instructions for use to incorporate new requirements (especially in terminology and MR safety symbols).
• Facility & Device Security: For settings using sealed radioactive sources, coordinate between equipment suppliers and site security teams to ensure alignment with EN IEC 63322:2025. Develop and test access controls, intrusion detection, and incident procedures accordingly.
• Training: Implement targeted training for staff in clinical, engineering, asset management, and procurement roles regarding new risk assessment processes and updated labeling protocols.
• Procurement: Evaluate new and existing suppliers for conformity with ISO 5832-2:2025 (titaniumm implants) and IEC 62570:2025 (MR marking) as part of your purchasing criteria.

Priority recommendations:

• Address labeling and terminology standards promptly, as they often pre-condition device interoperability and regulatory submissions.
• For radiological security, treat compliance as a multidisciplinary responsibility crossing clinical engineering, IT, and facility security.
• Establish timelines for implementation in line with regulatory grace periods, but do not delay staff awareness programs and documentation reviews.

Getting started resources:

• Consult the full text of relevant standards through iTeh Standards for implementation guidance.
• Engage with technical committees and compliance forums for practical lessons learned and shared best practices.

Conclusion: Key Takeaways from September 2025

September 2025’s standards publications for Health Care Technology signal a meaningful shift toward safer, more standardized health care environments. The focus on precise terminology (ISO 19223-3:2025), enhanced safety labeling (IEC 62570:2025), advanced radiological source security (EN IEC 63322:2025), and improved biomaterial specifications (ISO 5832-2:2025) all address evolving industry challenges head-on.

Professionals in device manufacturing, clinical engineering, procurement, compliance, and quality management should review these standards closely. Timely adoption ensures regulatory alignment, reduces operating risks, and supports the broader goal of safe, reliable, and interoperable health care devices and infrastructure.

Stay informed and up to date—explore the full standards on iTeh Standards and prioritize the most relevant updates for your clinical or operational context.