Health Care Technology Standards Update: Dental and Biocompatibility Guidance, November 2025

In November 2025, international standards for health care technology saw essential updates across dental materials and ethical conduct in medical device testing. This fourth and final part in our monthly series explores three significant standards: the latest requirements for dental syringe cartridge seals, precise endodontic material specifications, and up-to-date guidance on animal welfare during biological evaluation. Dental manufacturers, clinical practitioners, laboratory managers, and health technology regulators will discover how these developments sharpen product safety, compliance, and ethical responsibility across the sector.

Overview / Introduction

Health care technology is evolving rapidly, especially as device innovation, patient safety, and ethical research standards reach new heights. For dental and medical device professionals, adhering to up-to-date international standards is not just about compliance—it directly influences patient outcomes and public trust. Robust standards ensure medical and dental products are safe, effective, and produced ethically. In this article, you'll find:

• An in-depth look at three new standards published in November 2025
• Detailed requirements for dental local anaesthetic cartridge seals and endodontic sealing materials
• Guidance on minimizing animal testing and promoting humane practices in medical device evaluation

Whether you lead compliance teams, oversee clinical operations, or procure medical devices, understanding and applying these standards will raise your quality and competitive edge.

Detailed Standards Coverage

ISO 11040-3:2025 – Seals for Dental Local Anaesthetic Cartridges

Prefilled syringes – Part 3: Seals for dental local anaesthetic cartridges

ISO 11040-3:2025 defines the precise requirements for seals used in single-use dental local anaesthetic cartridges. The standard outlines:

• Shape and dimensions: Strict geometric specifications ensuring compatibility and efficacy
• Materials: Approved elastomeric compositions, including rubber and thermoplastic elastomers (TPE), to guarantee chemical stability and product integrity
• Physical and biological performance requirements: Tests for hardness, fragmentation, leak resistance, resistance to ageing, and biocompatibility
• Labelling: Detailed requirements that support traceability and inform users about correct handling, storage, and regulatory compliance

Who must comply? Manufacturers of dental anaesthetic cartridges and supply chain partners will need to ensure that seals meet this revised specification. Regulatory agencies and dental clinics relying on prefilled syringes also benefit from standardized quality. Implementation improves both patient safety and product reliability.

Notable changes from the previous edition (ISO 11040-3:2012):

• Introduction of a new terms and definitions section for clearer understanding
• Updated normative references
• Expansion of geometric requirements, including aluminium thickness and new dimensions
• Clarified terms, replacing ambiguous words (e.g., “liner” replaces “disc” for seal components)
• Enhanced material descriptions, including coated surfaces
• Updated figures and tables reflecting current manufacturing practices

Key highlights:

• Covers full technical requirements for shape, material, and performance
• Sets standards for cleanliness, chemical purity, and accurate labelling
• Recent revision includes clarity and dimensional updates for modern manufacturing

Access the full standard:View ISO 11040-3:2025 on iTeh Standards

ISO 6876:2025 – Dentistry: Endodontic Sealing Materials

Dentistry – Endodontic sealing materials

This newly revised international standard establishes classification, key requirements, and comprehensive test methods for endodontic sealing materials—vital products in root canal therapy and dental restoration. ISO 6876:2025 applies to:

• Type 1: Materials for conventional orthograde endodontic sealing, typically paired with obturating points
• Type 2: Materials for procedures such as apexification, perforation filling, resorption treatment, or retrograde root-end filling (including uses in vital pulp therapy)

Scope and compliance: All dental manufacturers producing endodontic sealers, QA officers, and dental clinics utilizing these materials must ensure conformity to:

• Physical performance: Uniform appearance, minimum flow (≥17 mm for Type 1), film thickness (≤50 µm), adequate working and setting times
• Chemical resistance: Solubility and disintegration not exceeding 3.0% by mass
• Radiopacity: Minimum of 3.0 mm Al/mm ensures the material can be properly visualized in radiographic images, vital for clinical verification
• Marking, packaging, and correct labelling: Supporting traceability and regulatory acceptance globally

Major updates in this edition:

• Broader coverage including new types of sealing materials and associated uses
• Enhanced clarity in test methods (especially for flow, working time, and solubility)
• Reference to the latest radiopacity measurement (ISO 13116)
• Alternative methods for working time included (see Annex A)

Key highlights:

• Includes new material type classifications and extended clinical applications
• Refined, stricter requirements for key properties (flow, solubility, radiopacity)
• Updated test methods and harmonization with international best practices

Access the full standard:View ISO 6876:2025 on iTeh Standards

prEN ISO 10993-2 – Biological Evaluation of Medical Devices: Animal Welfare Requirements

Biological evaluation of medical devices – Part 2: Animal welfare requirements (ISO/DIS 10993-2:2024)

This draft European and international standard establishes the minimum requirements for ensuring the welfare of animals used in biocompatibility testing for medical devices. It is intended for sponsors, scientific directors, ethical committees, and laboratory personnel involved in medical device biological evaluation.

What does it cover?

• Justification for animal tests: Animal testing is allowed only when essential, and after all scientifically valid non-animal alternatives have been considered and/or exhausted
• Personnel requirements: Mandates competence, training, and ongoing qualification for all personnel involved
• Planning and conducting studies: Framework for research design focused on minimizing animal use and suffering
• Animal care and accommodation: High standards; specific requirements for purpose-bred animals, housing, veterinary care, and humane endpoints (including euthanasia where appropriate)
• Refinement, reduction, and replacement (3Rs): Encourages validated replacement alternatives and continual review of animal use
• Documentation and data management: Requires written protocols, thorough reporting, and justification for methodology

Practical implications: Institutions and sponsors commissioning or evaluating animal studies must align their processes with the 3Rs—replacement, reduction, and refinement of animal testing. This ensures both ethical compliance and the scientific validity of biocompatibility data submitted for device approvals. Ethical review boards and laboratory managers play key roles in overseeing adherence.

Key highlights:

• Essential and detailed requirements for animal welfare in device testing
• Emphasis on using alternatives and minimizing animal distress
• Structured protocols for planning, execution, and review of animal studies

Access the full standard:View prEN ISO 10993-2 on iTeh Standards

Industry Impact & Compliance

These latest updates strengthen safety, quality, and ethical oversight in dental and medical technology production and research. Here’s how the standards affect businesses:

• Manufacturers: Must update processes, supply chain assurance, and staff training to meet enhanced requirements, especially where product labelling or test documentation is affected.
• Quality managers and compliance officers: Need to audit against the new requirements, update SOPs, and ensure electronic and paper documentation are up to date.
• Research and testing labs: Must demonstrate compliance with new animal welfare criteria (prEN ISO 10993-2) and maintain robust records for audits and regulatory reviews.

Compliance considerations and timelines:

• Transition periods may be specified by regulators—early adoption demonstrates proactive quality management
• Failure to align with new requirements can result in product recalls, regulatory penalties, or exclusion from key markets, particularly in the EU and globally where ISO and EN standards are aligned
• Internal and supply chain training is crucial to avoid errors in product specification and regulatory filings

Benefits of adoption:

• Enhanced patient safety and clinical performance
• Reduced business risk from recalls, regulatory action, or litigation
• Improved brand reputation by demonstrating commitment to global best practices and animal welfare

Risks of non-compliance:

• Regulatory enforcement actions, delays in product approvals or renewals
• Legal liability arising from adverse events or substandard performance
• Damage to business reputation and stakeholder trust

Technical Insights

Across these standards, several themes emerge to inform implementation best practices:

• Product Design & Material Selection: Choose compliant, traceable materials—particularly elastomers for dental cartridge seals—to ensure chemical stability and biocompatibility.
• Labelling and Documentation: Review labelling protocols and ensure new specifications and warnings are integrated and traceable throughout the product lifecycle.
• Testing and Quality Assurance: Implement the updated testing methodologies for flow, setting time, solubility, and radiopacity in endodontic materials; validate animal study protocols per international 3Rs requirements.
• Certification and Audit Readiness: Prepare for third-party audits by updating documentation, study protocols, and staff training records. Leverage the standards’ guidance as a framework for certifying bodies and internal audit programs.
• Supply Chain Communication: Proactively share updated standard requirements with material suppliers and contract research organizations to avoid downstream nonconformities.

Implementation best practices:

1. Map all product and process changes needed for compliance with updated standards.
2. Schedule gap analysis with cross-functional teams—R&D, QA, regulatory affairs, and procurement.
3. Update technical files and risk management documentation as per the latest standards.
4. Train staff and suppliers on significant changes and new compliance thresholds.
5. Establish regular review cycles for future standards updates—consider subscribing to alerts from iTeh Standards.

Conclusion / Next Steps

The November 2025 updates to health care technology standards demand immediate attention from dental and medical device organizations. The new ISO 11040-3:2025 and ISO 6876:2025 standards bring precision, safety, and reliability to dental products—while prEN ISO 10993-2 reinforces the industry’s ethical responsibilities in animal testing.

Key takeaways:

• Update your manufacturing protocols for dental cartridge seals and endodontic materials
• Ensure animal testing practices align with new ethical and scientific safeguards
• Review and disseminate new requirements across quality, production, and clinical teams

Recommendations:

• Begin an internal gap assessment and engage with your notified body or competent authority about timelines
• Train your teams using the official standard documents accessible online
• Monitor iTeh Standards for future updates and related guidance

Explore the full set of health care technology standards and ensure your products and processes stay ahead of regulatory, quality, and ethical expectations. Stay updated with iTeh Standards for ongoing changes and resources.