EN ISO 9394:2012 PDF

Name: EN ISO 9394:2012 — Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)
SKU: EN ISO 9394:2012
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Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)

Название (английский):

EN ISO 9394:2012

Ophthalmic optics - Contact lenses and contact lens care products - Determination of biocompatibility by ocular study with rabbit eyes (ISO 9394:2012)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 21
Дата публикации:: 1 октября 2012 г.
Издание:: CEN EN 9394 edition 2 version 1
ICS:: 11.040.70

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Описание (английский):

ISO 9394:2012 specifies an in vivo method of test to assess the ocular safety of both novel contact lens material and contact lens care products. The test assesses the degree of irritation to the ocular tissue produced by the device under test. The test method is described in application to rabbit eyes.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 9394:2012 - Ophthalmic optics: Contact lenses and contact lens care products - specifies an in vivo ocular study using rabbit eyes to determine biocompatibility and the degree of ocular irritation caused by contact lens materials and care products. The standard describes test design, animal husbandry, examination procedures (slit‑lamp, fluorescein staining), histology and data reporting. It is intended to support safety evaluation within a device risk‑management program and to be used in conjunction with relevant biological evaluation standards.

Key topics and technical requirements

Test method: In vivo ocular exposure of contact lenses or lens care–treated lenses on rabbit eyes to evaluate irritation and tolerance.

Animals and husbandry: Typically New Zealand white or equivalent albino rabbits, healthy young adults, >2.5 kg; minimum of three rabbits (six recommended); individual housing and identification; acclimatization and welfare in accordance with ISO 10993‑2.

Good practice: Studies conducted under GLP/ISO/IEC 17025 and OECD GLP principles; qualified personnel perform assessments.

Specimen preparation: Lenses selected to represent human use extremes or product line extremes, ensuring adequate fit to rabbit eye; lenses prepared and handled per manufacturer and care‑product instructions.

Examinations and measurements:

Slit‑lamp microscopy (with filters) and magnification for anterior eye assessment.
Fluorescein staining to detect corneal epithelial damage.
Body weight monitoring, histological examination and optional corneal metabolism assays.
Use of standardized scoring systems (e.g., McDonald‑Shadduck, Draize scale) for lesion/irritation grading (annexes in the standard).

Controls and reporting: Contra‑lateral eye or matched control group recommended; positive controls discouraged. Detailed test report required documenting lens parameters, procedures, observations and conclusions.

Practical applications

Safety assessment of novel contact lens materials, coatings and contact lens care products (cleaners, disinfectants, solutions) prior to clinical use.

Generating regulatory and technical evidence for manufacturers, test laboratories and regulatory submissions.

Supporting product development decisions (material selection, formulation changes) and post‑market safety investigations.

Related standards

ISO 10993‑1, ISO 10993‑2, ISO 10993‑10 (biological evaluation and animal welfare)

ISO 18369‑1 (contact lens vocabulary/classification)

ISO/IEC 17025 (laboratory competence)

OECD Principles of Good Laboratory Practice

EN ISO 9394:2012 provides a standardized, documented approach for in vivo ocular biocompatibility testing, helping ensure reproducible safety data for contact lenses and lens care products while emphasizing animal welfare and regulatory compliance.

EN ISO 9394:2012 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications

Who uses this standard

Related standards

Технические детали

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