ISO 11979-3:2012 PDF

Name: ISO 11979-3:2012 — Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods
SKU: ISO 11979-3:2012
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Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods

Название (английский):

ISO 11979-3:2012

Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 31
Дата публикации:: 6 декабря 2012 г.
Издание:: ISO IS 11979 edition 3 version 1
ICS:: 11.040.70

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Описание (английский):

L'ISO 11979-3:2012 spécifie les exigences et les méthodes d'essai élaborées pour certaines propriétés mécaniques des lentilles intraoculaires (LIO). L'ISO 11979-3:2012 s'applique à tous les types de LIO destinées à une implantation dans le segment antérieur de l'oeil humain, à l'exclusion des implants de la cornée, sous réserve que la méthode d'essai soit appropriée pour un modèle de LIO en particulier.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO 11979-3:2012 - "Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods" specifies required mechanical properties and laboratory test methods for intraocular lenses (IOLs) intended for implantation in the anterior segment of the eye (excluding corneal implants). The third edition extends coverage to toric IOLs and accommodating IOLs (AIOLs) and defines how manufacturers must measure and report mechanical performance under in‑situ conditions.

Key topics and technical requirements

Scope and sampling: Tests are performed on a minimum of three IOL lots (medium power; include low/high if dioptric power affects results). Minimum sample size is 10 IOLs per lot; means and standard deviations for pooled samples must be reported.

Test environment: Mechanical properties are determined at in‑situ conditions (solution composition must be reported); justified alternative conditions may be used with explanation.

Dimensional tolerances: Tolerances for overall diameter, vault height and sagitta are specified (different values for anterior chamber, multi‑piece posterior chamber, and other IOLs). Clear optic tolerance is ±0.15 mm; clear optic diameter must be > 4.25 mm.

Compression force and axial displacement: Measured per Annex A/B at defined compressed diameters: 10 mm for capsular bag placement, 11 mm for sulcus placement (both if applicable), and manufacturer‑recommended minima/maxima for anterior chamber IOLs.

Optic decentration and tilt: Decentration measured per Annex C should meet the limit that (mean + 2 SD) ≤ 10% of clear optic; tilt (Annex D) must satisfy (mean + 2 SD) ≤ 5°.

Angle of contact and compression force decay: Angle of contact measured (Annex E); residual compression force reported after 24 h ± 2 h (Annex F).

Dynamic fatigue durability: Loops must withstand 250 000 cycles of near‑sinusoidal deformation of ±0.25 mm without breakage (Annex G); test distances depend on intended placement.

AIOLs: Manufacturers must describe the theoretical mechanism of action and characterize mechanical behavior across the full functional range.

Practical applications - who uses this standard

IOL manufacturers - design verification, quality control, regulatory submission data.

Regulatory agencies and notified bodies - conformity assessment for safety and performance dossiers.

Test laboratories - standardized methods for compression, fatigue, decentration, tilt and durability testing.

Clinicians and risk analysts - understanding mechanical behavior relevant to implantation, clearance analysis (anterior chamber lenses) and clinical investigation needs.

Related standards

ISO 11979 series (related parts): Part 1 (Vocabulary), Part 2 (Optical properties and test methods), Part 4–10 (labelling, biocompatibility, shelf‑life, clinical investigations, fundamental requirements, multifocal and phakic IOLs). ISO/TR 22979 referenced for assessing clinical investigation needs.

Keywords: ISO 11979-3:2012, intraocular lenses, IOL mechanical properties, test methods, ophthalmic implants, compression force, optic decentration, dynamic fatigue durability, accommodating IOLs.

ISO 11979-3:2012 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications - who uses this standard

Related standards

Технические детали

BS EN ISO 11979-4:2026

Ophthalmic implants — Intraocular lenses. Labelling and information.

ISO/TR 22979:2006

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