Overview
EN ISO 11979-7:2024 (ISO 11979-7:2024) defines the particular requirements for clinical investigations of intraocular lenses (IOLs) implanted to correct aphakia. This fifth edition (published January 2024 and endorsed by CEN) supersedes the 2018 edition and provides updated clinical testing guidance for a range of IOL designs, including newly defined non-accommodative Simultaneous Vision IOLs (SVIOLs) and subtypes such as multifocal (MIOL), extended depth of focus (EDF) and full visual range (FVR) lenses.
Key topics and requirements
The standard focuses on practical, safety- and performance-related elements of IOL clinical investigations. Major topics include:
- Justification for clinical investigation and ethical considerations for human studies
- General requirements and study design principles applicable to all IOL types
- Specific design and testing requirements for:
- Toric IOLs (TIOL) - controls for astigmatism correction
- Simultaneous Vision IOLs (SVIOL/MIOL/EDF/FVR) - definitions and aligned testing methodologies
- Accommodating IOLs (AIOL) - assessment of dynamic accommodation performance
- Anterior chamber IOLs - additional safety and anatomical considerations
- Characteristics to be evaluated: visual acuity outcomes, refractive results, safety endpoints, and device‑specific performance measures
- Study logistics: enrolment, bilateral implantation, surgical technique consistency, follow-up duration, adverse event reporting, inclusion/exclusion criteria
- Annexes A–G covering: general clinical elements, additional elements for toric/SVIOL/accommodating IOLs, adverse event evaluation, clinical tests, and statistical/sample size guidance
Practical applications
This standard is used to plan and conduct clinical investigations that demonstrate the safety and performance of IOLs for regulatory submission, CE marking, and clinical evidence generation. Typical applications:
- Designing pivotal or post-market clinical studies for new or modified IOLs
- Preparing clinical evaluation reports for regulatory and notified bodies
- Harmonizing endpoints and tests across different IOL technology types (toric, multifocal, EDF, accommodating)
- Informing surgeon training and standardized surgical protocols for study consistency
Who should use this standard
- IOL manufacturers and product development teams
- Clinical researchers and ophthalmic trial investigators
- Regulatory and notified bodies, ethics committees, and clinical study monitors
- Ophthalmic surgeons involved in clinical trials or device evaluation
Related standards
EN ISO 11979-7:2024 is part of the ISO 11979 series for ophthalmic implants. Related documents (under revision or alignment) include ISO 11979-1, -2, -4 and ISO/TR 22979, which cover other aspects of IOL specification, testing and terminology.
Keywords: EN ISO 11979-7:2024, ISO 11979-7, intraocular lenses, IOL clinical investigations, aphakia, toric IOL, multifocal IOL, EDF, accommodating IOL, clinical testing, ophthalmic implants.
