January 2026: New Contact Lens Standards Enhance Care Product Safety

Advancements in health care technology continue to enhance product safety and effectiveness, and January 2026 marks a significant update for the ophthalmic sector. Two vital new international standards, ISO 11986:2026 and ISO 11987:2026, have been published to guide manufacturers, laboratories, and regulatory professionals in the design, testing, and lifecycle management of contact lenses and their associated care products. These additions align with the broader trend toward stricter, evidence-based practices and reinforce commitments to patient safety, product integrity, and regulatory compliance.

Overview / Introduction

The field of ophthalmic optics is at the intersection of medical innovation and stringent regulatory oversight. Contact lenses and their care products are integral to daily life for millions. Yet, their safety depends on precise testing and clear quality specifications to prevent irritation, infection, and product degradation during storage and use.

Standards in this sector are crucial—they establish requirements for risk management, product performance, and patient protection. By understanding the latest updates, professionals can:

Ensure compliance with international regulations and best practices
Reduce risks tied to preservative exposure, microbial contamination, and shelf-life uncertainty
Safeguard end-users and strengthen product claims during audits and market access

This article analyzes two major standards published in January 2026, unpacking their technical requirements and implications for the contact lens industry.

Detailed Standards Coverage

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

This comprehensive standard introduces general procedures for the selection of analytical methods, preparation of contact lens samples, and the conduct and reporting of preservative uptake and release tests. The uptake and release of preservatives from contact lens materials can lead to user discomfort or, in some cases, adverse reactions.

Scope and Application:

Focuses exclusively on new and unused contact lenses and their interactions with care product preservatives during the development phase (not as routine checks for finished goods)
Inapplicable to lenses after clinical wear since mineral and organic deposits can interfere with test reproducibility
Clarifies that the standard does not evaluate disinfection performance, though preservative depletion can affect disinfection efficacy

Key Requirements and Specifications:

Selection of immersion and analytical methods appropriate for the preservative type
Rigorous sample preparation at controlled temperatures (25°C ± 2°C)
Measurement of preservative concentration at set intervals until steady-state is achieved
Subsequent testing of the preservative's release in a saline solution, referencing ISO 18369-3 for saline preparation
Detailed test reporting, including sample handling, methods used, and result expression

Target Users:

Manufacturers developing new contact lens materials or care products
Research and development laboratories
Regulatory compliance officers in ophthalmic product companies

Practical Implications:

Enables robust characterization of material-preservative interaction
Helps mitigate risks of preservative-induced toxicity or irritation in end-users
Supports claims during product submissions and approvals

Notable Changes:

Editorial updates for clarity and consistency
Scope now explicitly references use during product development only

Key highlights:

Standardizes the measurement of preservative uptake and release
Applies only to new, unused lenses to ensure test reproducibility
Underpins regulatory submissions for new lens materials or care products

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

ISO 11987:2026 - Shelf-Life Determination for Contact Lenses

Ophthalmic optics — Contact lenses — Determination of shelf-life

Setting a scientifically justified shelf-life is a fundamental requirement for contact lens manufacturers and suppliers. ISO 11987:2026 provides a comprehensive structure for stability testing, ensuring that lenses remain safe and effective through storage, distribution, and until the consumer opens the packaging.

Scope and Application:

Defines procedures for stability studies of contact lenses in their final packaging
Results are used to establish expiry dates and recommend storage conditions
Stability testing focuses on material integrity, packaging performance, and environmental resistance (e.g., elevated temperatures and humidity)

Key Requirements and Specifications:

Risk assessment protocol to identify critical properties for testing
Real-time and accelerated ageing studies performed with controlled environmental chambers (typically at 25°C ± 2°C and higher if needed)
Measurements of lens material properties, pack integrity, sterility, and extractables according to referenced standards (notably, parts of ISO 18369)
Expression of results in relation to shelf-life claims and product labeling
Comprehensive test reporting, including methodology, environmental conditions, and outcomes

Target Users:

Contact lens manufacturers
Quality assurance and packaging engineers
Regulatory and compliance officers

Practical Implications:

Ensures that products consistently meet safety and efficacy claims through distribution
Supports risk-based decision-making for packaging and storage innovations
Provides data needed to fulfill regulatory and audit requirements worldwide

Notable Changes:

Editorial clarity enhancements
Explicit direction clarifying that a new shelf-life study is unnecessary for minor lens design variations (if no material or packaging changes)

Key highlights:

Establishes detailed requirements for shelf-life studies, including accelerated testing
Helps define accurate expiry dates for regulatory and market assurance
Integrates risk assessment as a basis for stability protocols

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

Industry Impact & Compliance

With the release of ISO 11986:2026 and ISO 11987:2026, health care organizations active in ophthalmic product development face updated protocols that directly impact their innovation cycles, quality management processes, and regulatory strategies:

Industry Impact:

Streamlines R&D: Developers can rely on unified procedures for critical preservative and stability assessments, reducing ambiguity and harmonizing data sets for submissions.
Regulatory Alignment: Both standards reinforce compliance pathways for organizations targeting diverse markets, aiding in product registration and reducing post-market surveillance risks.
Consumer Confidence: Clearer expiry dating and well-characterized preservative behavior bolster patient safety and public trust, reducing recalls and adverse event reports.

Compliance Considerations:

Implementation: New product developments must integrate these methods into early-stage formulation and verification.
Timeline: Immediate compliance is expected upon standard adoption, especially for submissions after January 2026.
Risk of Non-Compliance: Omitting validation per these documents may delay market access or expose firms to regulatory sanctions.

Benefits:

Better defined product performance
Reduced risk of preservative-related adverse reactions
Efficient, reproducible shelf-life determination

Technical Insights

Common Technical Requirements:

Controlled testing environments (precise temperature and humidity)
Use of reference saline as per ISO 18369-3 for measurement consistency
Analytical specificity for preservatives and extractables based on intended use

Implementation Best Practices:

Integrate standard methods during product design and pre-clinical evaluation phases
Document all process controls and test environments comprehensively under quality management systems
Utilize a risk assessment framework to determine necessity and extent of shelf-life or preservative uptake studies
Maintain traceability of sample handling and conditioning—especially for regulatory compliance audits

Testing & Certification Considerations:

Where third-party certification is necessary, ensure selected laboratories deploy the prescribed standards and validated methods
For in-house testing, implement robust calibration, documentation, and sample management protocols aligned with ISO 17025 and equivalent requirements

Conclusion / Next Steps

As health care technology and regulatory expectations evolve, so must the standards that underpin patient safety and product reliability. The introduction of ISO 11986:2026 and ISO 11987:2026 represents a decisive step toward harmonized, evidence-based practices in the ophthalmic sector. Professionals engaged in research, product development, quality assurance, or regulatory affairs should:

Review and implement relevant procedures outlined in these standards for all new contact lens and care product developments
Coordinate with quality and regulatory teams to ensure documentation and reporting align with the newest requirements
Monitor future updates by subscribing to standards news and alerts through platforms like iTeh Standards

For a deeper dive, direct access to these standards is essential. By leveraging the latest guidelines, organizations can uphold global quality benchmarks, minimize risk, and optimize patient outcomes.