March 2026: New Standards Set Higher Bar for Health Care Technology

Medical technology is seeing a transformative shift this March with the publication of five landmark standards shaping safer devices, better clinical practices, higher-quality elder care, rigorous natural medicine quality, and effective infection control. From biological evaluation protocols for implants to robust care guidelines for older persons and trustworthy washer-disinfector requirements, these standards are set to raise performance and safety benchmarks across the health care industry.

Overview / Introduction

The health care sector relies fundamentally on internationally harmonized standards to assure patient safety, drive innovation, and meet ever-stringent regulatory requirements. Standards underpin every aspect of the industry, from product development and clinical investigation to the daily delivery of care and equipment reprocessing. The freshly published March 2026 health care technology standards represent significant progress — offering clarity and unified requirements for stakeholders worldwide.

Whether you're developing medical devices, designing clinical trials, managing elder care, trading herbal medicines, or ensuring hygienic environments, understanding the scope and requirements of these new standards is essential. This article guides you through the practical and technical implications of each, underlining what’s changed, who must comply, and how your organization can benefit.

Detailed Standards Coverage

FprEN ISO 10993-6 - Biological Evaluation of Implants

Biological evaluation of medical devices – Part 6: Tests for local effects after implantation (ISO/FDIS 10993-6:2025)

This critical standard defines the protocols for assessing local biological effects that medical device materials may produce after implantation. It applies to solid, non-solid, absorbable, non-absorbable, and tissue-engineered products, covering the diverse landscape of contemporary implant technologies.

Key requirements and specifications:

• Prescribes selection, preparation, and implantation of samples using suitable animal models
• Specifies macroscopic and microscopic tissue assessment (subcutaneous, muscle, bone, brain, peripheral nerve tissue)
• Demands comprehensive documentation of test conditions, sample preparation, surgery, evaluation, and reporting
• Emphasizes harmonization with risk management per ISO 10993-1, animal welfare, and robust control material selection
• Adds new test approaches (e.g., steady-state, use of coupons, evaluation of devices in nerve tissue), reflecting advances in material science and regulatory scrutiny

Who must comply:

• Medical device manufacturers designing devices intended for implantation
• Biocompatibility and regulatory affairs professionals
• Laboratories conducting preclinical evaluations

Practical implications:

• More detailed protocols and reporting promote consistency and reproducibility
• Expanded scope for new device types (e.g., tissue-engineered products)
• Alignment with regulatory requirements such as the EU Medical Device Regulation (MDR)

Notable changes:

• New requirements for control materials and sample coupon use
• Expanded annexes on tissue evaluation, including nerve and brain tissue
• Enhanced guidance on animal welfare and integration with systemic toxicity studies

Key highlights:

• Clearer criteria and methods for local tissue response testing
• Broader tissue types evaluated
• Increased harmonization with global regulatory trends

Access the full standard:View FprEN ISO 10993-6 on iTeh Standards

ISO 14155:2026 - Clinical Investigation Good Practices

Clinical investigation of medical devices for human subjects — Good clinical practice

This globally referenced standard sets authoritative requirements for designing, conducting, and reporting clinical investigations of medical devices in human subjects. It codifies the principles of Good Clinical Practice (GCP) to protect subjects and ensure data credibility, cementing its place as a cornerstone of device approval and conformity assessment.

Key requirements and specifications:

• Outlines ethical, scientific, and organizational requirements for clinical studies
• Covers planning (risk management, justifications, clinical investigation plan), conduct (site selection, monitoring, adverse event handling), and documentation
• Details sponsor and investigator responsibilities, informed consent, subject privacy, and device accountability
• Applies principles to both pre-market and, where relevant, post-market clinical investigations
• Addresses software as a medical device (SaMD), requiring demonstration of analytical, scientific, and clinical validity

Who must comply:

• Medical device manufacturers and clinical research organizations (CROs)
• Clinical trial coordinators, monitors, and data managers
• Regulatory authorities and ethics committees overseeing device investigations

Practical implications:

• Ensures protection of human subjects and scientific validity
• Supports international harmonization and recognition of clinical data
• Satisfies regulatory expectations across key markets (EU, US, Asia-Pacific)

Notable changes:

• Expanded guidance for SaMD, strengthening digital health evidence
• Increased focus on documentation, electronic data integrity, and adverse event reporting
• Enhanced integration of ethics committee oversight

Key highlights:

• GCP principles codified for medical devices
• Expanded coverage for software and connected devices
• Detailed, actionable requirements for all study stages

Access the full standard:View ISO 14155:2026 on iTeh Standards

ISO 25557:2026 - Care Quality for Older Persons

Ageing societies — Care quality for older persons at home and in care facilities

As societies age worldwide, ensuring consistent, high-quality care for older adults is critical. This new standard offers holistic requirements and guidance for the delivery of health and social care to older persons, regardless of setting, provider size, or structure.

Key requirements and specifications:

• Stresses person-centered care meeting individual needs, dignity, participation, safety, and security
• Applies to both home-based and facility care, including preventive, supportive, palliative, and end-of-life services
• Covers workforce recruitment, training, and equity, along with quality management, risk mitigation, and emergency preparedness
• Requires attention to inclusivity, accessibility, information transfer, and infection prevention

Who must comply:

• Care homes, home care agencies, public and private care providers
• Workforce managers, quality assurance professionals, and service planners
• Policymakers framing eldercare systems

Practical implications:

• Enables benchmarking and quality improvement across care settings
• Empowers providers to meet international expectations on safety, quality, and inclusion
• Facilitates procurement and contracting of high-quality care services

Notable features:

• Comprehensive applicability regardless of funding model or provider type
• Practical guidelines supporting integrated, continuous care
• Encourages equity and diversity in aging care workforces

Key highlights:

• Holistic requirements for older person care
• Provider and workforce guidance
• Supports improvement and auditing

Access the full standard:View ISO 25557:2026 on iTeh Standards

ISO 25115:2026 - Cultivated Cistanche Deserticola Stem Quality

Traditional Chinese medicine — Cultivated Cistanche deserticola stem

This standard seeks to harmonize international trade and ensure the quality and safety of cultivated Cistanche deserticola stem, a prized ingredient in traditional Chinese medicine with significant global demand.

Key requirements and specifications:

• Details requirements for identification, physical characteristics, and macroscopic features
• Sets specifications for moisture, ash, extractives, chemical markers (echinacoside, verbascoside)
• Defines thresholds for heavy metals and pesticide residues, referencing related ISO test methods
• Mandates clean, uncontaminated, and properly labelled products
• Provides protocols for sampling, testing, packaging, storage, and transportation

Who must comply:

• Growers and exporters of Cistanche deserticola stem
• Herbal medicine processors and quality managers
• Procurement professionals and importers in health supply chains

Practical implications:

• Reduces risk of adulteration, contamination, or misidentification in global trade
• Facilitates regulatory compliance in major markets
• Supports sustainable cultivation and reduction of wild harvesting

Notable features:

• Encourages documentation proving cultivated origin to protect endangered species
• Supports harmonization across international pharmacopoeia requirements
• Provides methods for differentiation from similar species

Key highlights:

• International standardization of a key traditional medicine ingredient
• Robust safety and quality controls
• Supports sustainable and safe herbal medicine markets

Access the full standard:View ISO 25115:2026 on iTeh Standards

EN ISO 15883-6:2026 - Washer-Disinfectors for Non-Critical Medical Devices

Washer-disinfectors – Part 6: Requirements and tests for washer-disinfectors employing thermal disinfection for non-critical medical devices and health care equipment (ISO 15883-6:2026)

With hygiene at the core of safe health care delivery, this updated standard specializes in requirements for washer-disinfectors processing non-critical medical devices — items contacting intact skin, not requiring sterilization, and frequently used in health care settings.

Key requirements and specifications:

• Prescribes minimum standards for cleaning and thermal disinfection (A0 ≥ 60)
• Defines product scope (non-invasive, non-critical devices, e.g., wheelchairs, trays, containers)
• Includes detailed performance, mechanical, and control system checks
• Addresses process water quality, system validation, and user guidance
• Requires alignment with ISO 15883-1 (general washer-disinfector requirements) and ISO 15883-5 (performance test criteria)

Who must comply:

• Manufacturers of washer-disinfectors
• Health care facilities procuring and operating reprocessing equipment
• Quality managers and infection prevention specialists

Practical implications:

• Promotes consistent device cleanliness and infection control without unnecessary documentation burdens
• Clarifies device suitability: excludes powered, lumened, critical, and semi-critical items (see related ISO 15883 parts)
• Aligns with EU Medical Device Regulation General Safety and Performance Requirements

Notable updates:

• Title and scope revised for clarity (focus on non-critical items)
• Enhanced water quality and cleaning verification requirements
• Harmonized terminology with latest global definitions

Key highlights:

• Clear, practical protocols for non-critical device reprocessing
• Alignment with modern compliance and technical standards
• Supports effective infection control in diverse clinical settings

Access the full standard:View EN ISO 15883-6:2026 on iTeh Standards

Industry Impact & Compliance

Embracing these new standards is not only a regulatory imperative; it’s a catalyst for operational excellence and risk mitigation in health care technology.

• For device manufacturers: Up-to-date biological evaluation and clinical investigation standards mean smoother product approval, higher global marketability, and minimized recall risk.
• For care providers: Adhering to elder care standards helps mitigate liability, elevates reputation, and fosters patient trust.
• For herbal product suppliers: Harmonized cultivation and trading requirements open new markets while ensuring product integrity.
• For hospital administrators and infection control personnel: Verified washer-disinfector performance supports accreditation, patient safety, and operational efficiency.

Compliance considerations:

• Review your QMS and SOPs for alignment with the latest requirements
• Assess gaps and plan staff training on new clinical, care, or manufacturing protocols
• Update product technical documentation and test reports as per revised standards
• Ensure supplier and partner contracts reference the current standards
• Monitor deadlines for regulatory adoption and certification to maintain market access

Failure to update processes in line with new standards not only endangers patient safety but also risks regulatory penalties, business continuity, and reputation.

Technical Insights

Common technical requirements across these standards include:

• Rigorous documentation and reproducibility in testing (sample preparation, reporting, adverse event tracking)
• Holistic risk management strategies (across design, care delivery, supply chain)
• Alignment with harmonized terminology and global definitions
• Use of validated analytical methods and quality controls (for biocompatibility, clinical data, herbal material testing, reprocessing efficacy)
• Processes for independent verification, routine monitoring, and periodic staff training

Best practices for implementation:

1. Gap analysis: Systematically compare current processes and protocols to new requirements
2. Stakeholder training: Ensure all responsible personnel understand new procedures and documentation
3. Supplier engagement: Communicate new requirements to suppliers and verify compliance
4. Leverage digital systems: Use electronic data capture and traceability systems for documentation, reporting, and audit readiness
5. Continuous improvement: Establish feedback mechanisms and regular reviews of procedures, particularly in evolving fields like clinical investigations and care services

Testing and certification:

• Engage accredited laboratories for preclinical, analytical, and performance testing
• Prepare for third-party audits in device manufacturing and care provision
• Maintain comprehensive, auditable records for regulatory submissions and market surveillance

Conclusion / Next Steps

With the publication of these five key standards, March 2026 marks an important milestone for health care technology. Organizations that proactively understand and implement these requirements will achieve higher safety, compliance, and performance outcomes — and maintain their leadership in a fast-evolving market.

Recommended next steps:

• Download and review the full text of each standard from iTeh Standards
• Convene compliance and technical teams to evaluate internal policies
• Update quality management systems, procurement processes, and staff training as necessary
• Monitor for further updates and ensure continuous alignment with international best practices

Ready to lead in health care technology? Explore all March 2026 health care standards on iTeh Standards and stay at the forefront of safety, quality, and innovation.