ISO 14730:2014

Name: ISO 14730:2014 — Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date
SKU: ISO 14730:2014
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Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date

Название (английский):

ISO 14730:2014

Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on determining discard date

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 23
Дата публикации:: 30 сентября 2014 г.
Издание:: ISO IS 14730 edition 2 version 1
ICS:: 11.040.70

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Описание (английский):

ISO 14730:2014 specifies a procedure to be used in evaluating the antimicrobial preservative activity of all preserved multidose contact lens care products, and provides guidance on methods to be used for determination of discard date as informative annexes.

Abstract

Похожие стандарты

Упомянутые в описании и другие стандарты ISO

Overview

ISO 14730:2014 - "Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date" defines a standardized test method for evaluating the antimicrobial preservative activity of preserved multidose contact lens care products (CLCP). The standard sets out the test principle (initial microbial challenge and a 14‑day rechallenge), sampling schedule, storage conditions and requirements for neutralization or removal of residual antimicrobials. Informative annexes provide example procedures for determining product discard date (including membrane filtration and extended‑dating approaches).

Key topics and technical requirements

Scope: Applies to preserved multidose contact lens solutions (up to a 28‑day discard date). Excludes single‑use sterile unit doses and containers with physical contamination barriers (e.g., aerosols).

Test principle: Inoculate product with specified microorganisms, store at controlled temperature, sample at defined intervals and monitor viable counts to confirm preservative activity and prevention of regrowth.

Sampling and replication: Three product lots are tested; each lot uses a separate inoculum preparation per challenge organism.

Challenge organisms: Standard test strains specified (including common bacteria, yeast and mould used in preservative testing).

Timing and conditions: Sampling includes key time points (including day 7, day 14, and post‑rechallenge at day 21 and day 28); storage at 20 °C to 25 °C and protection from light if product is photosensitive.

Neutralization and recovery: Validated neutralizing agents or membrane filtration are required to remove or inactivate residual antimicrobials prior to plating; effectiveness of neutralization must be validated.

Performance criteria and reporting: Performance requirements are provided in the standard (see clause 5.6) and full test reporting requirements are specified.

Practical applications and users

Who uses ISO 14730:2014:

Contact lens solution manufacturers (R&D and quality control) for product development and batch release.

Independent microbiology and contract test laboratories performing preservative efficacy testing.

Regulatory affairs teams preparing safety and labeling documentation (discard/use‑after‑opening dates).

Clinical safety assessors and post‑market surveillance teams evaluating preservative performance.

Practical use cases:

Demonstrating that a multidose CLCP maintains antimicrobial activity during intended use.

Supporting decisions on discard dates (up to 28 days) and using annex procedures to justify extended dating.

Standardizing preservative efficacy data for regulatory submissions and product labeling.

Related standards

ISO 14534 - Contact lenses and contact lens care products: fundamental requirements

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

Keywords: ISO 14730:2014, contact lens care products, preservative efficacy testing, antimicrobial preservative, discard date, multidose contact lens solution, ophthalmic optics.

ISO 14730:2014

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

SIST EN ISO 14534:2015

Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

ISO 18369-1:2017

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