SIST EN ISO 13212:2014 PDF

Name: SIST EN ISO 13212:2014 — Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)
SKU: SIST EN ISO 13212:2014
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Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)

Название (английский):

SIST EN ISO 13212:2014

Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life (ISO 13212:2014)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 15
Дата публикации:: 14 октября 2014 г.
ICS:: 11.040.70
Технический комитет:: VAZ - Healthcare

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Описание (английский):

ISO 13212:2011 provides guidance on the design of stability studies for use in gathering information to enable determination of the shelf-life of contact lens care products. ISO 13212:2011does not address studies designed to obtain information to establish the in-use stability (i.e. notice of discard date) of contact lens care products.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

EN ISO 13212:2014 - Ophthalmic optics - Contact lens care products - Guidelines for determination of shelf-life - provides internationally recognized guidance for designing stability studies to determine the shelf-life of contact lens care products. Published as an ISO standard and adopted by CEN, it outlines how to gather the physicochemical and microbiological data needed to define shelf-life and any required storage conditions. Note: this standard does not cover in‑use stability (the discard/“in‑use” date).

Key topics and technical requirements

Objective: Establish data-driven shelf-life and storage instructions that maintain safety, performance and acceptability.

Study design: Guidance on planning stability testing based on active ingredient properties, formulation and intended use.

Study types:

Real‑time studies (typical evaluation at temperatures between 20 °C and 30 °C; recommended mean kinetic testing temperature 25 °C ± 2 °C).
Accelerated / varying storage condition studies to support initial shelf-life or extensions (multiple temperatures, humidity, light, freeze–thaw).

Environmental factors: Control of temperature, relative humidity (high humidity up to 75 % ± 5 % for solids; low humidity considerations for aqueous products and semi‑permeable packaging), and light exposure.

Analytical methods: Use validated, stability‑indicating assays able to distinguish active ingredients from degradation products; report methods in full.

Product characterization: Assess active content, purity, physicochemical and microbiological properties, and container/closure interactions.

Data handling: Presentation, interpretation and documentation of stability results; support for initial shelf‑life claims and future extensions.

Ongoing stability: Continued monitoring after product launch to assure shelf-life and labelling remain appropriate.

Practical applications and users

This standard is essential for:

Contact lens care product manufacturers (R&D, formulation, QA/QC)

Regulatory affairs professionals preparing shelf-life submissions

Analytical and stability testing laboratories

Packaging engineers evaluating container/closure interactions

Notified bodies and auditors assessing compliance with ophthalmic product requirements

Use EN ISO 13212:2014 to design stability protocols, justify storage instructions on labels, and support regulatory dossiers with robust shelf-life data.

Related standards

ISO 14729 - Microbiological requirements and test methods for contact lens care products

ISO 14730 - Antimicrobial preservative efficacy testing and discard date guidance

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

Keywords: EN ISO 13212:2014, contact lens care products, shelf-life determination, stability studies, ophthalmic optics, stability‑indicating methods, storage conditions.

SIST EN ISO 13212:2014 PDF

Abstract

Похожие стандарты

Overview

Key topics and technical requirements

Practical applications and users

Related standards

Технические детали

ISO 13212:2014

Ophthalmic optics — Contact lens care products — Guidelines for determination of shelf-life

ISO 14729:2001/Amd 1:2010

Ophthalmic optics — Contact lens care products — Microbiological requirements and test methods for products a…

SIST EN ISO 14730:2015

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

ISO 18369-1:2017

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