ISO 11981:2017 PDF

Name: ISO 11981:2017 — Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses
SKU: ISO 11981:2017
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Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses

Название (английский):

ISO 11981:2017

Ophthalmic optics — Contact lenses and contact lens care products — Determination of physical compatibility of contact lens care products with contact lenses

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 7
Дата публикации:: 30 ноября 2017 г.
Издание:: ISO IS 11981 edition 3 version 1
ICS:: 11.040.70

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Описание (английский):

ISO 11981:2017 describes the general procedure and performance criteria for assessing the physical compatibility of contact lens care products with contact lenses and for determining whether the observed changes are reversible.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 11981:2017 - "Ophthalmic optics - Contact lenses and contact lens care products - Determination of physical compatibility of contact lens care products with contact lenses" - defines a standardized procedure and performance criteria for assessing the physical compatibility between contact lenses and lens care products, and for determining whether observed changes are reversible or irreversible. The standard guides laboratory testing that simulates real‑world use and compares measured lens parameters against baseline values and tolerances.

Key topics and technical requirements

Scope and principle

Measures changes in key lens characteristics after cycling in a care product and, when needed, after re‑equilibration in a standard saline solution.
Baseline measurements are taken after equilibration in standard saline (pH 7.4 ± 0.1; nominal osmolarity 310 ± 5 mOsm).

Selection and sample size

Minimum of 10 test lenses per lens material × care product combination.
Test lens groups should represent intended use (see ISO 18369-1 material groupings).

Cycling protocols

Simulate manufacturer instructions for use (volumes, temperatures, times).
Typical temperature range: 20 °C to 25 °C.
For daily-use care products: 30 cycles per lens.
For scheduled products (e.g., enzymatic cleaners): cycles representing one month or ≥ five exposures.
For rewetting/lubricating drops: protocols that simulate one month of on‑eye use.

Measured properties

Diameter (hydrogel lenses), curvature (rigid lenses), back vertex power (all materials), spectral transmittance (cosmetic/UV lenses), and physical appearance (surface defects, colour).
Measurement methods referenced to ISO 18369‑3; tolerances referenced to ISO 18369‑2.

Reversibility testing

If changes exceed tolerances, lenses are re‑equilibrated in standard saline and re‑measured to classify changes as reversible or irreversible.

Reporting

Test report must include lens and product identification (lot/expiry), protocol, results (baseline and post‑test), laboratory name, responsible person and signature, and test dates.

Practical applications and users

Intended for manufacturers of contact lenses and contact lens care products to validate compatibility claims.

Useful for regulatory submissions, product development, quality control, and independent testing laboratories.

Beneficial to clinical researchers and standards teams assessing material interactions, product labeling, and real‑world use simulation.

Related standards

ISO 18369‑1:2017 - vocabulary, classification and labelling recommendations

ISO 18369‑2 - tolerances for contact lens parameters

ISO 18369‑3:2017 - measurement methods for contact lenses

ISO 18259:2014 and ISO 18369‑4 referenced for complementary test methods and material properties

Keywords: ISO 11981:2017, contact lens compatibility, contact lens care products, physical compatibility testing, standard saline solution, ophthalmic optics, contact lens materials.

ISO 11981:2017 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

ISO 18369-1:2017

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

ISO 18369-3:2017

Ophthalmic optics — Contact lenses — Part 3: Measurement methods

ISO 18259:2014

Ophthalmic optics — Contact lens care products — Method to assess contact lens care products with contact len…

SIST EN ISO 18369-3:2017

Ophthalmic optics - Contact lenses - Part 3: Measurement methods (ISO 18369-3:2017)

ISO 18369-2:2017

Ophthalmic optics — Contact lenses — Part 2: Tolerances

SIST EN ISO 18369-4:2017

Ophthalmic optics - Contact lenses - Part 4: Physicochemical properties of contact lens materials (ISO 18369-…