EN ISO 11979-6:2014 PDF

Name: EN ISO 11979-6:2014 — Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)
SKU: EN ISO 11979-6:2014
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Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)

Название (английский):

EN ISO 11979-6:2014

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:2014)

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 19
Дата публикации:: 15 октября 2014 г.
Издание:: CEN EN 11979 edition 2 version 1
ICS:: 11.040.70

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Язык документа:

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Срок поставки:4 раб. дн. (перевод)

Цена:285 €

Описание (английский):

ISO 11979-6:2014 specifies tests by which the shelf-life of sterile intraocular lenses (IOLs) in their final packaging can be determined. These tests include procedures to establish the stability of IOLs in distribution and storage.

Abstract

Overview

Key topics and requirements

Scope and purpose: Establishes tests and study design to demonstrate that IOL performance, safety and acceptability remain within specifications during storage and distribution.
Risk-based approach: Requires a risk analysis per ISO 14971 to decide whether product stability, package integrity or transport studies are needed and to justify test selection.
Study protocol: A documented protocol must be prepared before testing; results must demonstrate compliance with finished product specifications or applicable ISO 11979 limits, or be compared to time‑zero product.
Test articles: Studies use finished IOL lots (or finished injector systems with IOLs). If resterilization is possible, stability samples should have undergone the maximum allowed sterilization cycles.
Real-time and accelerated testing:
- Accelerated studies are acceptable for initial shelf-life claims but must be verified by a subsequent real‑time study.
- A maximum of five years shelf-life may be claimed initially from either real-time or accelerated studies; real-time results take precedence.
Sampling and test selection:
- For optical-power–sensitive parameters, test low/medium/high dioptric groups.
- Sample sizes and guidance are provided in Annex A; suggested tests and methods appear in Annex B.
- Test methods not in Annex B must be documented and validated.
Package integrity and transport: Includes procedures to assess sterile barrier performance and IOL stability during distribution and transport.

Practical applications

Supports labeling decisions (expiration date and storage/transport conditions) for IOL manufacturers.
Validates packaging systems and sterilization processes in line with product stability needs.
Informs supply chain and distribution controls to preserve IOL safety and efficacy.
Used by contract testing labs, quality assurance, regulatory affairs, and notified bodies reviewing technical documentation for market approval.

Who uses this standard

IOL manufacturers and R&D teams
Packaging engineers and sterilization specialists
Quality control and regulatory affairs professionals
Contract testing laboratories and conformity assessment bodies

Related standards

ISO 11979 series (Parts 1–10) - intraocular lenses
ISO 14971 - risk management for medical devices
ISO 11607-1 / ISO 11607-2 - packaging for terminally sterilized medical devices
ISO 10993-5 / ISO 10993-12 - biocompatibility testing

Keywords: EN ISO 11979-6:2014, intraocular lenses, IOL shelf-life testing, transport stability, packaging integrity, accelerated ageing, real-time stability, ISO 14971.

Технические детали

Технический комитет: CEN/TC 170 - Ophthalmic optics
SKU: EN ISO 11979-6:2014

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ISO 11979-6:2014

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Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing

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EN ISO 11979-6:2014 PDF

Abstract

Overview

Похожие стандарты

Key topics and requirements

Practical applications

Who uses this standard

Related standards

Технические детали

ISO 11979-6:2014

Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing

BS/AAMI 34971:2023

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

BS EN ISO 11979-4:2026

Ophthalmic implants — Intraocular lenses. Labelling and information.

ISO 11607-1:2019/Amd 1:2023

Packaging for terminally sterilized medical devices — Part 1: Requirements for materials, sterile barrier sys…

ISO 11607-2:2019/Amd 1:2023

Packaging for terminally sterilized medical devices — Part 2: Validation requirements for forming, sealing an…

ISO 10993-5:2009

Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity

SIST EN ISO 10993-1:2026

Biological evaluation of medical devices - Part 1: Requirements and general principles for the evaluation of…