EN ISO 11979-10:2018 PDF

Overview

EN ISO 11979-10:2018 (ISO 11979-10:2018) - "Ophthalmic implants - Intraocular lenses - Part 10" specifies clinical-investigation requirements for phakic intraocular lenses (IOLs) implanted in the anterior segment with the primary aim of modifying refractive power. The standard covers three optical categories of phakic IOLs:

• Phakic monofocal (PIOL)
• Phakic multifocal (PMIOL)
• Phakic toric (PTIOL)

Each category is further designated by intended implantation location (anterior or posterior chamber). EN ISO 11979-10:2018 focuses on clinical aspects not fully addressed in other ISO 11979 parts and updates prior editions to include multifocal and toric phakic designs.

Key Topics

• Scope and definitions related to phakic IOLs and ametropia correction in phakic eyes.
• Clinical investigation design: requirements and recommendations for planning clinical studies, including justification for new models and risk-based approaches for modifications of existing devices.
• Characteristics to evaluate: optical, mechanical and functional clinical endpoints appropriate for PIOL, PMIOL and PTIOL designs.
• Additional design-specific requirements: extra clinical considerations for phakic multifocal and phakic toric lenses (e.g., visual performance across distances and astigmatic correction).
• Safety and performance monitoring: duration of follow-up, adverse-event reporting, bilateral implantation considerations, surgical technique, and post-operative examinations.
• Supportive elements: statistical methods and sample-size guidance (Annex B) and recommended elements for clinical investigations (Annex A).
• Integration with other parts of ISO 11979: cross-references to requirements on vocabulary, optical/mechanical test methods, labelling, biocompatibility, shelf-life and transport stability (e.g., ISO 11979-1 to ISO 11979-8).

Applications

Who uses EN ISO 11979-10:2018 and why:

• Medical device manufacturers developing or modifying phakic IOLs - to design compliant clinical investigations and demonstrate safety/performance for regulatory submissions.
• Clinical researchers and ophthalmic surgeons - to align trial protocols, inclusion/exclusion criteria, follow-up schedules and adverse-event reporting with international best practice.
• Regulators and notified bodies - to assess clinical evidence for market approval and post-market surveillance.
• Contract research organizations (CROs) and statisticians - for study planning, sample-size calculations and outcome analysis.

Keywords useful for search: EN ISO 11979-10:2018, phakic intraocular lenses, clinical investigations, PIOL, PMIOL, PTIOL, ophthalmic implants, ISO 11979.

Related Standards

Key referenced parts of the ISO 11979 series include:

• ISO 11979-1 (Vocabulary)
• ISO 11979-2 / -3 (Optical & mechanical test methods)
• ISO 11979-4 (Labelling and information)
• ISO 11979-5 / -6 / -7 / -8 (Biocompatibility, and other device-specific requirements)

EN ISO 11979-10:2018 should be used alongside these parts to ensure comprehensive technical and clinical compliance.