January 2026: Essential Updates for Contact Lens Standards in Health Care Technology

In January 2026, the field of health care technology sees significant advancements with the publication of two vital international standards for ophthalmic optics and contact lens safety. EN ISO 11986:2026 and EN ISO 11987:2026 deliver new procedures and requirements for evaluating preservative interactions with contact lenses and determining the true shelf-life of packaged products. These updates are critical for manufacturers, researchers, quality managers, and regulatory professionals dedicated to patient safety and product reliability.

Overview / Introduction

Contact lenses and their care products represent a cornerstone of modern vision correction, impacting millions of patients globally. The technology and regulatory landscape for these devices are continually evolving to address new risks, material innovations, and market demands. International standards in this sector, such as those published under the scope of health care technology, play a crucial role in defining best practices, ensuring safety, and streamlining compliance across borders.

This article will guide you through the latest changes introduced in January 2026, focusing on two newly released standards that will shape the future of contact lens development and quality assurance. You’ll gain insight into their revised scope, practical requirements, industry implications, and technical best practices.

Detailed Standards Coverage

EN ISO 11986:2026 - Preservative Uptake and Release in Contact Lenses

Ophthalmic optics – Contact lenses and contact lens care products – Determination of preservative uptake and release (ISO 11986:2026)

This comprehensive international standard outlines the procedures for assessing how contact lenses absorb and subsequently release preservatives from care solutions. It offers guidance on the selection of testing methods, sample preparation, and analytical procedures relevant to the development phase of new contact lens materials or care products.

Not a routine production test, this standard is critical for R&D teams and regulatory affairs professionals when introducing new polymer formulations or disinfecting solutions. By understanding preservative uptake and release, manufacturers can better predict patient comfort, minimize risks of irritation or allergic reactions, and provide robust data for product claims and regulatory submissions.

Notably, the 2026 edition introduces editorial updates and clarifies that these methods are to be used specifically during product development, not for ongoing batch control or finished goods certification.

Scope and Key Requirements:

• Defines methods for measuring preservative absorption by new contact lenses (unused, uncontaminated by wear deposits).
• Covers conditions and protocols for releasing absorbed preservatives into an aqueous medium.
• Excludes evaluation of disinfection effectiveness directly; focuses purely on chemical uptake and release dynamics.
• Does not set finished product specifications but aims to inform the design and safe use of new lenses and care solutions.

Who Should Comply:

• Contact lens manufacturers and developers
• R&D and quality control departments
• Regulatory bodies evaluating new submissions for market approval
• Suppliers of contact lens care products

Practical Implications:

• Supports risk assessment for preservative-induced eye sensitivity and performance during lens wear.
• Helps optimize formulations to minimize adverse reactions.
• Facilitates compliance with European and global regulatory frameworks for product safety assessments.

Key highlights:

• Applies only to new and unused contact lenses to ensure reproducibility
• Does not assess real-world lens deposits from wear (scope limitation)
• Incorporates an editorial update and enhanced guidance for development teams

Access the full standard:View EN ISO 11986:2026 on iTeh Standards

EN ISO 11987:2026 - Shelf-Life Determination of Contact Lenses

Ophthalmic optics – Contact lenses – Determination of shelf-life (ISO 11987:2026)

EN ISO 11987:2026 introduces robust procedures for the stability assessment of contact lenses during storage and distribution. By specifying real-time and accelerated aging studies in the context of final packaging, this standard empowers manufacturers to assign scientifically justified expiry dates, improving patient safety and regulatory compliance.

This revised standard replaces EN ISO 11987:2012 and integrates editorial clarifications, especially regarding when shelf-life tests are required. It now clearly articulates that the underlying material’s stability (rather than minor design variations) is the primary determinant in the need for shelf-life verification.

Scope and Key Requirements:

• Outlines test protocols for both real-time studies (simulating actual storage conditions) and accelerated aging studies (shortening the evaluation period using higher temperature or stress factors).
• Requires evaluation of material stability, packaging integrity, and maintenance of sterile environment over the claimed shelf-life period.
• Test results directly support expiry date determination and recommended storage conditions.
• Refers to terminology and measurement standards in the ISO 18369 series, ensuring broad industry alignment.

Who Should Comply:

• Contact lens manufacturers and labeling teams
• Quality assurance and regulatory departments
• Ophthalmic distributors handling warehousing and logistics

Practical Implications:

• Enables evidence-based shelf-life labeling, preventing premature expiration depletion and minimizing risks of degraded product safety.
• Offers a harmonized methodology for stability studies required in EU and international regulatory dossiers.
• Supports development of storage/distribution protocols to maximize product quality through to the point of use.

Key highlights:

• Focus on packaging system and material stability rather than lens design changes
• Real-time and accelerated aging options detailed for comprehensive testing
• Ensures ongoing conformity with changing European and international regulations

Access the full standard:View EN ISO 11987:2026 on iTeh Standards

Industry Impact & Compliance

These January 2026 updates usher in a new era of diligence and precision for contact lens manufacturers and suppliers. By adopting EN ISO 11986:2026 and EN ISO 11987:2026, organizations align with the latest expectations of European and international regulators, thus reducing the risk of market barriers or product recalls due to non-conformance.

Compliance considerations include:

• Timely transition from older standards (withdrawal of previous versions by July 2026 in Europe)
• Revisiting development testing programs for new lens materials and care products
• Reviewing shelf-life validation processes for current and newly launched products
• Ensuring that labelling, expiry dating, and risk assessments reflect up-to-date test results and methodologies

Benefits of adopting the new standards:

• Greater confidence in safety claims and product performance
• Reduced liability and improved product stewardship
• Streamlined regulatory submissions and market approvals
• Enhanced reputation with clinicians, patients, and procurement organizations

Risks of non-compliance:

• Potential for regulatory enforcement, withdrawal of products, or negative market perception
• Increased risk of patient complaints and safety incidents
• Higher costs due to re-testing, re-labelling, or recall actions

Technical Insights

While each standard presents specific targets, several common technical themes and best practices emerge:

• Analytical Rigor: Both standards require the deployment of validated, precise testing methodologies—whether measuring chemical uptake/release or monitoring stability over time.
• Scope Limitation Awareness: EN ISO 11986:2026 is clear that results are not applicable to lenses exposed to real-world contaminants, while EN ISO 11987:2026 focuses on the stability of materials and packaging, not just design modifications.
• Documentation and Traceability: Robust test reporting, including full details of procedures and results, supports future audits and regulatory reviews.
• Harmonization: Cross-reference to ISO 18369 series secures a consistent vocabulary and measurement approach across related standards.

Implementation Best Practices

1. Integrate Early in Product Development: Apply preservative uptake/release testing during the design phase of new lenses and care products, well before market launch.
2. Review Packaging Materials: Ensure that both primary lens materials and the final packaging conform with shelf-life stability requirements.
3. Simulate Real-World Conditions: Use real-time studies reflecting actual distribution environments, while leveraging accelerated studies for rapid feedback during development.
4. Maintain Thorough Records: Detailed documentation enables traceability and streamlines both internal quality management and external audits.
5. Engage with Regulatory Teams: Collaborate with global compliance experts to ensure alignment with local and international registration requirements.
6. Ongoing Training: Regularly educate laboratory staff and quality management personnel on revised procedures to minimize errors and misinterpretations.

Testing and Certification Considerations

• Establish defined protocols for sample selection, storage conditions, and result interpretation.
• Engage independent accredited testing laboratories when third-party validation is required.
• Monitor updates from standards organizations for any future amendments or related guidelines.

Conclusion / Next Steps

The January 2026 publication of EN ISO 11986:2026 and EN ISO 11987:2026 marks a pivotal step forward for the contact lens sector within health care technology. These standards underpin new levels of safety and transparency, guiding manufacturers, researchers, and quality assurance teams through the next generation of product development and market approval.

Key takeaways:

• Both standards are essential for anyone involved in the design, development, and distribution of contact lenses and care products.
• Up-to-date compliance ensures product claims meet regulatory expectations, protects patients, and strengthens organizational reputation.
• Proactive adoption and training will position organizations to succeed in a competitive, highly regulated marketplace.

To stay ahead in this dynamic sector, organizations are encouraged to review the full standards, update their internal protocols, and consult with quality and regulatory experts as needed.

For more details and direct access to complete documents, visit:

View EN ISO 11986:2026 on iTeh Standards

View EN ISO 11987:2026 on iTeh Standards

Explore these authoritative sources today and ensure your health care technology operations reflect the latest in safety, efficacy, and regulatory excellence.