ISO 18189:2016 PDF

Name: ISO 18189:2016 — Ophthalmic optics — Contact lenses and contact lens care products — Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions
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Ophthalmic optics — Contact lenses and contact lens care products — Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions

Название (английский):

ISO 18189:2016

Ophthalmic optics — Contact lenses and contact lens care products — Cytotoxicity testing of contact lenses in combination with lens care solution to evaluate lens/solution interactions

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 9
Дата публикации:: 30 мая 2016 г.
Издание:: ISO IS 18189 edition 1 version 1
ICS:: 11.040.70

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Описание (английский):

Iso 18189:2016 describes an in vitro test method to assess the potential cytotoxic effects that may arise due to interaction of contact lenses with contact lens care solutions. NOTE The potential of a contact lens or a contact lens care solution to cause cytotoxicity by itself can be evaluated in accordance with general guidance in ISO 10993‑5.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 18189:2016 - "Ophthalmic optics - Contact lenses and contact lens care products - Cytotoxicity testing of contact lenses in combination with lens care solution" - specifies an in vitro test method to assess potential cytotoxic effects from interactions between contact lenses and lens care solutions. The standard focuses on direct-contact testing to detect lens-mediated release or concentration of solution ingredients (e.g., preservatives) that could harm ocular cells. (Note: standalone cytotoxicity of a lens or solution is covered by ISO 10993‑5.)

Key topics and requirements

Test principle: direct-contact cytotoxicity using contact lenses pre‑soaked in the lens care solution and placed onto a confluent monolayer of L‑929 cells.

Sample preparation: lenses are incubated in ~10 ml of the care solution (or DPBS for lens controls) for 24 h ± 2 h at room temperature with gentle agitation; lenses may be cut (pinwheel) before testing.

Cell system and culture: L‑929 fibroblast cells (ATCC NCTC clone 929), seeded to form subconfluent monolayers in Minimal Essential Medium (MEM) with 5% serum; incubations at 37 °C ± 1 °C and 5% ± 1% CO2.

Controls and acceptance criteria:

Positive control: latex (1 cm × 1 cm), expected grade ≥ 3 in all four replicates.
Negative control: high density polyethylene (HDPE, 0.5 mm thick, 1 cm × 1 cm), expected grade ≤ 1.
Lens control: lens soaked in DPBS, expected grade ≤ 1.
Test validity requires these control criteria be met.

Endpoint and scoring: after 24 h ± 2 h contact, remove specimens, stain with Trypan Blue, and assess cell morphology and zone of lysis. Reactivity grades range 0 (none) to 4 (severe); grades > 2 indicate cytotoxic effect.

Measurement guidance: Annex A describes measuring the zone of cell lysis and plate layout.

Applications and users

Contact lens and lens care solution manufacturers for product development and compatibility testing.

Biocompatibility and analytical laboratories performing preclinical in vitro testing.

Regulatory and quality assurance teams preparing safety dossiers and ensuring compliance with ophthalmic device safety expectations.

R&D teams evaluating interactions across conventional and silicone hydrogel lens materials with representative multipurpose solutions.

Practical benefits include early identification of adverse lens/solution interactions, reduced risk in clinical testing, and support for regulatory submissions.

Related standards

ISO 10993‑5 - Biological evaluation of medical devices - Tests for in vitro cytotoxicity (general guidance).

ISO 18369‑1 - Contact lens vocabulary, classification, and labelling (referenced for terms and definitions).

Keywords: ISO 18189, cytotoxicity testing, contact lenses, lens care solutions, in vitro test, L‑929 cells, ISO 10993‑5.

ISO 18189:2016 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and users

Related standards

Технические детали

ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

BS ISO 18189:2016

Ophthalmic optics. Contact lenses and contact lens care products. Cytotoxicity testing of contact lenses in c…

ISO 18369-1:2017

Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labell…