SIST EN ISO 11979-7:2024 PDF

Name: SIST EN ISO 11979-7:2024 — Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024)
SKU: SIST EN ISO 11979-7:2024
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Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024)

Название (английский):

SIST EN ISO 11979-7:2024

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia (ISO 11979-7:2024)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 59
Дата публикации:: 15 февраля 2024 г.
Издание:: CEN EN 11979 edition 2 version 1
ICS:: 11.040.70

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Описание (английский):

This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

Abstract

Overview

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.

Технические детали

Технический комитет: VAZ - Healthcare
SKU: SIST EN ISO 11979-7:2024

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