March 2026: New Standards Shape Health Care Technology for Enhanced Patient Safety

The dynamic field of health care technology continues its commitment to patient safety, product quality, and effective clinical outcomes through the constant evolution of international standards. In March 2026, five pivotal standards have been published that address a spectrum of emerging needs, from traditional medicinal plant sourcing to advanced medical oxygen systems. These influential updates reflect the industry's increasing focus on regulated quality, transparency, and risk management—delivering clarity and best practices for organizations, manufacturers, healthcare providers, and compliance teams worldwide.

Overview / Introduction

Health care technology encompasses a diverse set of domains, including pharmaceuticals, medical devices, assistive products, and life-sustaining systems. At every stage — from research and raw material sourcing to manufacturing, labelling, and clinical deployment — adherence to up-to-date standards is vital. Standards not only ensure safety and efficacy but also harmonize compliance globally, streamline procurement criteria, support market approvals, and underpin patient trust.

This article unpacks the March 2026 standards in: traditional Chinese medicine herbal material practices, intraocular lens labelling, incontinence product evaluation, liquid oxygen medical systems, and oxygen-conserving medical equipment. For quality managers, industry professionals, engineers, and procurement specialists, understanding these updates is essential for meeting international requirements and leading the way in health care quality and innovation.

Detailed Standards Coverage

ISO 24898:2026 - General Requirements for Herbal Material Cultivation

Traditional Chinese medicine — General requirements for the cultivation and primary processing of herbal materials

This standard provides a comprehensive framework for the cultivation, collection, and primary processing of medicinal plants used in traditional Chinese medicine (TCM). Its detailed requirements guide growers, collectors, and processors through every critical phase: from seed selection, site evaluation, and cultivation protocols, through to harvesting methods, post-harvest processing, packaging, labelling, storage, and transportation. Notably, it includes practical formats for record-keeping at each stage, ensuring full traceability and quality assurance.

Key requirements include clear authentication of plant species, documentation of propagation material origin, stringent management of fertilizers and pesticides, and adherence to good agricultural and collection practices (GACP). The standard aids national and sectoral regulatory compliance and forms a basis for international harmonization of TCM product quality.

Who should comply: Herbal medicine producers, contract growers, processors, and organizations involved in TCM supply chains.

Practical implications: Implementation improves product traceability, reduces contamination risk, and ensures medicinal plants meet recognized international safety and efficacy standards. As the demand for herbal medicines grows, robust cultivation standards protect both end-users and global market access.

Key highlights:

• End-to-end requirements for seed selection, cultivation, and harvesting
• Detailed post-harvest processing and storage guidelines
• Sample formats for documentation and traceability

Access the full standard:View ISO 24898:2026 on iTeh Standards

EN ISO 11979-4:2026 - Labelling for Intraocular Lenses

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2026)

This standard defines the precise labelling requirements for intraocular lenses (IOLs), focusing on the information provided on packaging and accompanying documentation. It is designed to harmonize labelling practices globally, supporting accurate identification, safe handling, and effective use by clinicians and patients alike. Updates in this edition reflect new regulatory needs, updated information for novel lens types, and improved requirements for expiration dates, symbols, and electronic records.

Essential elements cover the provision of comprehensive instructions for use, patient implant cards, and information leaflets. There are also requirements for self-adhesive labels, special categories such as SVIOLs (Supplementary Intraocular Lenses), and optional digital information distribution where permitted by regulations. The standard replaces previous editions and incorporates changes aligned with ISO 20417 and new clinical safety requirements.

Who should comply: Manufacturers and distributors of ophthalmic implants, regulatory professionals, and quality assurance teams.

Practical implications: Ensures that IOLs are consistently identified and used safely worldwide, reduces the risk of medical errors, and supports regulatory submissions and medical device audits.

Key highlights:

• Updated packaging and expiration data labelling for IOLs
• Requirements for electronic information delivery
• Enhanced patient information materials and implant cards

Access the full standard:View EN ISO 11979-4:2026 on iTeh Standards

EN ISO 15621:2026 - Guidelines for Incontinence Product Evaluation

Absorbent incontinence products for urine, faeces, or both - General guidelines on evaluation (ISO 15621:2026)

This comprehensive guideline addresses the evaluation of absorbent incontinence products, serving adults and children affected by urinary and/or fecal incontinence. It provides a structured approach for stakeholders—including manufacturers, procurement specialists, health care professionals, and end users—to assess product performance using both laboratory and real-world user trials. The standard supports consistent evaluation, taking into account user needs, product characteristics (such as design, comfort, leakage control, skin health), and the care environment.

It also integrates updates in terminology, aligns with the latest ISO harmonization on incontinence aids, and offers guidance for interpreting results to support procurement and product selection decisions within health systems.

Who should comply: Device manufacturers, procurement officers, care providers, and healthcare organizations sourcing absorbent incontinence products.

Practical implications: Supports objective and comparative product assessment, guides selection to optimize user quality of life, and aids procurement teams in value-based purchasing.

Key highlights:

• Structured methodologies for clinical and lab testing
• Comprehensive user-centered evaluation factors
• Supports cost, safety, ergonomic, and sustainability assessments

Access the full standard:View EN ISO 15621:2026 on iTeh Standards

EN ISO 18777-1:2026 - Requirements for Medical Liquid Oxygen Systems

Transportable liquid oxygen systems for medical use - Part 1: Common requirements and particular requirements for base units (ISO 18777-1:2026)

This standard details the specifications for transportable liquid oxygen systems for medical use, specifically addressing both common requirements for all units and unique requirements for base units. It focuses on design, construction, labelling, safety, and usability of equipment used primarily in home care and professional health care environments. Updates from the previous edition broaden the scope to transfilling devices and clarify interface safety, risk management, and user instructions.

The standard lays out requirements for materials, environmental conditions, pressure and flow controls, electrical safety, stability, and maintenance. Manufacturers must also supply comprehensive instructions, technical markings, and pre-use safety checks.

Who should comply: Medical device manufacturers, equipment suppliers, and health care facilities deploying or maintaining liquid oxygen systems.

Practical implications: Adoption improves device compatibility, patient and operator safety, traceability, and supports compliance with both local and international regulations governing medical oxygen systems.

Key highlights:

• Enhanced requirements for risk management and usability
• Updated specifications for pressure, flow, and safety interlocks
• Comprehensive labelling and user instructions

Access the full standard:View EN ISO 18777-1:2026 on iTeh Standards

FprEN ISO 80601-2-67 - Safety and Performance of Oxygen-Conserving Equipment

Medical electrical equipment - Part 2-67: Particular requirements for basic safety and essential performance of oxygen-conserving equipment (ISO/FDIS 80601-2-67:2025)

This standard addresses the critical safety and essential performance requirements of oxygen-conserving medical devices and their accessories. Used primarily in home care settings—and often by lay users—these devices enable intermittent delivery of supplemental oxygen synchronized with the patient’s inspiratory cycle, thus optimizing oxygen use and patient mobility. The standard also applies to oxygen-conserving features integrated into multifaceted oxygen supply systems.

Key focus areas include risk management, basic and electrical safety, gas delivery accuracy, usability, compatibility with accessories, and comparative testing methods to distinguish device performance from continuous flow systems. The latest edition incorporates new marking requirements, cybersecurity considerations, uncertainty of measurement practices, and updated connector/interface standards.

Who should comply: Manufacturers and designers of oxygen-conserving devices, regulatory professionals, and health care procurement teams.

Practical implications: Ensures consistent and reliable oxygen therapy, minimizes waste and costs, and supports successful home care and facility use with high safety margins.

Key highlights:

• Rigorous design and testing requirements for active oxygen-conserving devices
• Enhanced usability, labelling, and risk management
• Updated requirements for interoperability and cybersecurity

Access the full standard:View FprEN ISO 80601-2-67 on iTeh Standards

Industry Impact & Compliance

The adoption of these standards will significantly impact medical device manufacturers, herbal medicine producers, health care facilities, and procurement teams. By aligning with these specifications:

• Businesses ensure regulatory compliance, meet local and international market demands, and facilitate streamlined product approvals.
• Quality and safety for patients are enhanced, as products are developed, labelled, and evaluated against robust technical criteria.
• Procurement processes become more transparent and efficient with clear, standardized requirements for assessment and selection.
• Documentation and traceability are improved, which is critical for recalls, audits, and ongoing quality control.

Organizations should establish compliance timelines that align with national adoption of these standards—many become mandatory as previous versions are withdrawn. To maximize value, companies should integrate requirements into supplier agreements, training, product development, and quality management systems.

Risks of non-compliance include regulatory action, delayed or denied market access, increased liability, and diminished reputation. Early adoption is recommended for sustained competitiveness.

Technical Insights

Across these standards, several technical themes are evident:

• Risk management and usability engineering: Both ISO 18777-1 and ISO 80601-2-67 emphasize risk analysis, usability, and clarity in user instructions, especially for life-supporting devices.
• Consistent and visible labelling: Updated requirements stress detailed labelling, expiration dating, and, where allowed, digital information access—for both devices and consumables.
• Traceability and documentation: Sample record templates (ISO 24898), implant cards, and user leaflets ensure transparency and patient safety across the care continuum.
• Testing and performance evaluation: Laboratory and user trial methods (ISO 15621, ISO 80601-2-67) set benchmarks for objective performance, supporting value-based procurement and security.
• Best practices for implementation:
  1. Conduct gap assessments of current products and processes against new standards.
  2. Update quality management and documentation protocols.
  3. Train staff in new labelling, evaluation, and usage procedures.
  4. Work closely with suppliers to align inputs and components.
  5. Prepare for certifications, audits, and regulatory submissions based on updated requirements.

Conclusion / Next Steps

The March 2026 health care technology standards offer a leap forward in product quality, patient safety, and regulatory alignment. Whether you are developing natural medicinal products, manufacturing advanced medical devices, or sourcing critical care equipment, these standards should be integrated into your operations without delay.

Key takeaways:

• International standards are core to market success and risk mitigation in health care technology.
• Each new requirement, from record-keeping to usability, represents an opportunity to refine and future-proof your products and practices.

Recommendations:

• Review and incorporate these standards into your quality and procurement frameworks.
• Invest in compliance training and stakeholder communication.
• Regularly visit iTeh Standards for the latest updates, guidance, and access to the full texts of each standard.

Stay at the forefront of technology, compliance, and quality in health care—explore, adopt, and lead with the latest international standards.