SIST EN ISO 14730:2015

Name: SIST EN ISO 14730:2015 — Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)
SKU: SIST EN ISO 14730:2015
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Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)

Название (английский):

Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date (ISO 14730:2014)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 31
Дата публикации:: 17 декабря 2014 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

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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

Стандарты, упомянутые в описании

Overview

EN ISO 14730:2014 (ISO 14730:2014) - "Ophthalmic optics - Contact lens care products - Antimicrobial preservative efficacy testing and guidance on determining discard date" specifies a standardized laboratory procedure to evaluate the antimicrobial preservative activity of preserved multidose contact lens care products (CLCPs). The standard defines a challenge-test approach, reporting expectations and informative annexes that give guidance for establishing product discard dates (the instruction-to-use period after opening). It is intended for multidose contact lens solutions and is not applicable to single‑use unit doses or containers with physical microbial barriers (e.g., certain aerosols).

Key topics and technical requirements

Test principle: Controlled microbial challenge at test start with a mandatory re-challenge at day 14; samples are stored and sampled at defined intervals to quantify viable organisms and demonstrate prevention of regrowth.

Scope limit: The main test method covers products with discard dates up to 28 days. Informative annexes provide example procedures useful when extending discard dates beyond 28 days.

Microorganisms: A defined panel of challenge organisms is required (examples listed in the standard include Pseudomonas aeruginosa, Staphylococcus aureus, Escherichia coli, Candida albicans and Aspergillus brasiliensis).

Culture and recovery: Sampling, culturing and viable‑count methods are specified. Measures to inactivate or remove residual antimicrobial agents during culturing must be applied and validated to avoid false-negative results.

Performance criteria and controls: The standard sets criteria for acceptable preservative efficacy (see clause on performance criteria) and requires appropriate procedural controls and validated recovery procedures.

Test documentation: A comprehensive test report format is specified (test organism details, inoculum preparation, sampling times, recovery methods, and results).

Applications and who uses this standard

Contact lens solution manufacturers: for product development, preservative selection, stability and discard-date determination.

Quality control and microbiology testing laboratories: to perform standardized preservative efficacy tests and validate recovery/inactivation methods.

Regulatory affairs teams and notified bodies: to assess conformance and safety claims for multidose CLCPs.

R&D teams: to design preservative systems balancing antimicrobial efficacy and ocular safety.

Useful for stakeholders concerned with product labeling, shelf-life after opening, and contamination risks from repeated dispensing.

Related standards

ISO 14534 - Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements

ISO 18369-1 - Ophthalmic optics - Contact lenses - Vocabulary, classification and labelling recommendations

EN endorsement: this ISO document is published as EN ISO 14730:2014 by CEN.

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

SIST EN ISO 14730:2015

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Applications and who uses this standard

Related standards

Технические детали

ISO 14730:2014

Ophthalmic optics — Contact lens care products — Antimicrobial preservative efficacy testing and guidance on…

SIST EN ISO 14534:2015

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

ISO 18369-1:2017

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