ISO 14534:2011 PDF

Name: ISO 14534:2011 — Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements
SKU: ISO 14534:2011
Price: 25 EUR
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Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements

Название (английский):

ISO 14534:2011

Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 10
Дата публикации:: 22 марта 2011 г.
Издание:: ISO IS 14534 edition 3 version 1
ICS:: 11.040.70

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Описание (английский):

ISO 14534:2011 specifies safety and performance requirements for contact lenses, contact lens care products, and other accessories for contact lenses. ISO 14534:2011 does not specify electrical safety and electromagnetic compatibility considerations that might arise from the use of electrical equipment in conjunction with contact lenses or contact lens care products.

Abstract

Похожие стандарты

Стандарты, упомянутые в описании

Overview

ISO 14534:2011 - "Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements" defines the core safety and performance expectations for contact lenses, contact‑lens care products and related accessories. The standard sets out what manufacturers must document and demonstrate (design, materials, clinical performance, microbiological control, packaging, shelf‑life and labelling). It does not cover electrical safety or electromagnetic compatibility for electrical equipment used with contact lenses.

Key topics and requirements

Intended purpose and performance evidence: Manufacturers must document intended use and demonstrate performance using existing data, preclinical tests and, if needed, clinical investigations.

Risk assessment and management: A formal risk assessment using recognized methodologies is required and must be reviewed regularly and after product or process changes (referenced: ISO 14971).

Design, materials and biocompatibility: Design documentation, validation and verification are required. Materials selection must consider safety, compatibility and, for animal‑derived materials, compliance with ISO 22442. Biocompatibility evaluation follows ISO 10993‑1.

Clinical evaluation: Safety/performance must be supported by literature, prior use or clinical studies conducted in accordance with good clinical practice (ISO 14155; ISO 11980 guidance).

Microbiological requirements:

Sterile lenses and accessories must have documented sterilization methods and sterility assurance and be packaged to preserve sterility.
Non‑sterile lenses must be produced to achieve low bioburden (manufacturer to demonstrate average bioburden thresholds).
Solid and liquid care products have defined microbial limits, requirements for terminal sterilization or validated aseptic processing, preservative efficacy and antimicrobial activity (see ISO 14729, ISO 14730).

Packaging, shelf‑life and discard dating: Packaging must protect product integrity and be tamper‑evident where required. Shelf‑life and discard dates must be established by testing in accordance with ISO 11987 (lenses) and ISO 13212 (care products).

Labelling and information: Labelling must meet ISO 11978 and include mandatory instructions, warnings, replacement intervals, sterile/aseptic symbols (ISO 15223‑1) and instructions for disinfecting regimens.

Applications and users

ISO 14534:2011 is used by:

Contact lens and care‑product manufacturers (design, QC, regulatory submissions)

Regulatory and conformity assessment bodies evaluating safety/performance dossiers

Test laboratories performing microbiological, shelf‑life and biocompatibility testing

Quality and regulatory affairs professionals preparing labelling and risk files

Clinicians and eye‑care professionals referencing manufacturer information and safety claims

Related standards

Key normative references cited in ISO 14534:2011 include:

ISO 10993‑1 (biological evaluation)

ISO 11978, ISO 11980, ISO 11986 (product information, clinical guidance, preservative uptake)

ISO 14729, ISO 14730 (disinfection, preservative efficacy)

ISO 14971 (risk management)

ISO 11987, ISO 13212 (shelf‑life)

ISO 18369 series (vocabulary, tolerances, labelling)

Keywords: ISO 14534:2011, ophthalmic optics, contact lens standards, contact lens care products, microbiological requirements, shelf‑life, labelling, risk assessment.

ISO 14534:2011 PDF

Abstract

Похожие стандарты

Overview

Key topics and requirements

Applications and users

Related standards

Технические детали

BS/AAMI 34971:2023

Application of ISO 14971 to machine learning in artificial intelligence. Guide.

SIST EN ISO 22442-2:2021

Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and…

BS EN ISO 10993-11:2018

Biological evaluation of medical devices. Tests for systemic toxicity.

EN ISO 14155:2026

Clinical investigation of medical devices for human subjects - Good clinical practice (ISO 14155:2026)

SIST EN ISO 11980:2025

Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical in…

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…

SIST EN ISO 11987:2026

Ophthalmic optics - Contact lenses - Determination of shelf-life (ISO 11987:2026)