SIST EN ISO 11979-3:2013 PDF

Name: SIST EN ISO 11979-3:2013 — Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)
SKU: SIST EN ISO 11979-3:2013
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Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

Название (английский):

SIST EN ISO 11979-3:2013

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 39
Дата публикации:: 15 февраля 2013 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

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Описание (английский):

This part of ISO 11979 specifies requirements and test methods for certain mechanical properties of intraocular lenses (IOLs). It is applicable to all types of IOLs intended for implantation in the anterior segment of the human eye, excluding corneal implants, provided that the test method is appropriate to the particular IOL design.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 11979-3:2012 (Ophthalmic implants - Intraocular lenses - Part 3) defines required mechanical properties and test methods for intraocular lenses (IOLs) intended for implantation in the anterior segment of the human eye (excluding corneal implants). Published as a harmonized CEN/ISO document, it specifies how to measure and report mechanical characteristics that affect safety and performance of IOLs, including toric and accommodating designs.

Key Topics and Requirements

Scope and applicability

Applies to all anterior-segment IOLs where the test method is appropriate to the design.
Tests are to be performed at in situ conditions (solution composition reported); justified alternative conditions may be used and must be declared.

Sampling and reporting

Tests require a minimum of three IOL lots (medium dioptric power); if power affects results, include low, medium and high powers.
Minimum sample size: 10 IOLs per lot. Means and standard deviations for pooled samples must be reported.

Mechanical properties and defined tests

Compression force and axial displacement in compression (Annexes A & B)
Optic decentration and optic tilt (Annexes C & D)
Angle of contact, clearance analysis (anterior chamber lenses) (Annexes E & I)
Compression force decay, dynamic fatigue durability (Annexes F & G)
Surgical manipulation, surface and bulk homogeneity, and recovery after simulated surgery

Tolerances and dimensions

Tolerances specified for overall diameter, vault height and sagitta with distinct values for anterior-chamber, multi-piece posterior-chamber and other IOLs (e.g. overall diameter tolerances ±0.20 mm to ±0.30 mm depending on type).
Clear optic tolerance ±0.15 mm; clear optic diameter must be > 4.25 mm in any meridian.

Special provisions

Toric IOLs: sampling accounts for cylindrical powers (highest and lowest).
Accommodating IOLs (AIOLs): require description of mechanism of action, characterization over full range of movement/curvature, and time-dependent behavior if applicable.

Flexibility

If a prescribed method is not applicable to a particular IOL design, manufacturers may develop validated alternative methods with rationale.

Applications and Users

Primary users: IOL manufacturers, R&D teams, quality engineers, test laboratories, regulatory affairs professionals, and clinical investigators.

Practical uses:

Designing and validating IOL mechanical performance (durability, stability, handling).
Preparing technical documentation for regulatory submissions and clinical investigation planning.
Comparing designs (monofocal, toric, accommodating, multifocal) on standardized mechanical criteria.
Informing surgeons about handling, implantation behavior and expected in‑situ performance.

Related Standards

ISO 11979 series: Part 1 (Vocabulary), Part 2 (Optical properties), Part 4 (Labelling), Part 5 (Biocompatibility), Part 6 (Shelf-life), Part 7 (Clinical investigations), Part 8 (Fundamental requirements), Part 9 (Multifocal IOLs), Part 10 (Phakic IOLs).

Manufacturers should reference ISO 11979-1 and ISO 11979-2 when applying Part 3.

Keywords: EN ISO 11979-3:2012, intraocular lenses, mechanical properties, test methods, IOL testing, toric IOL, accommodating IOL, compression force, optic decentration, ophthalmic implants.

SIST EN ISO 11979-3:2013 PDF

Abstract

Похожие стандарты

Overview

Key Topics and Requirements

Applications and Users

Related Standards

Технические детали

ISO 11979-3:2012

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

BS EN ISO 11979-4:2026

Ophthalmic implants — Intraocular lenses. Labelling and information.

SIST EN ISO 11979-1:2026

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2026)

BS EN ISO 11979-2:2024

Ophthalmic implants. Intraocular lenses. Optical properties and test methods.