ISO 11979-6:2014 PDF

Name: ISO 11979-6:2014 — Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing
SKU: ISO 11979-6:2014
Price: 25 EUR
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Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing

Название (английский):

ISO 11979-6:2014

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

Статус документа:: Действующий
Формат:: Электронный (PDF)
Количество страниц:: 11
Дата публикации:: 24 сентября 2014 г.
Издание:: ISO IS 11979 edition 3 version 1
ICS:: 11.040.70

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Цена:165 €

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 - ISO 11979-6:2014 (Shelf-life and transport stability testing)

Key topics and technical requirements

Scope of testing: Product stability, package integrity, and transport stability for sterile IOLs in final packaging.
Study planning: Develop a study protocol and document rationale for chosen tests based on risk analysis.
Samples: Use finished IOL lots (including preloaded lens–injector systems when applicable); sample size guidance is provided in Annex A.
Test parameters (examples):
- Dimensions, dioptric power, imaging quality
- Surgical manipulation and recovery after deformation (for foldable IOLs)
- Surface and bulk homogeneity, spectral transmission
- Compression force, dynamic fatigue
- Exhaustive extraction and assessment of extractables; cytotoxicity if extractables increase
- Specific surface tests where warranted
Packaging and transport: Assess package integrity and transport stability; monitor temperature and relative humidity during storage.
Real-time vs accelerated testing: Accelerated studies may be used for initial labelling (maximum shelf-life claim up to five years) but must be verified by ongoing real-time studies; real-time results take precedence. Accelerated studies require controlled humidity (≥ 40 %) and follow the same test parameters as real-time studies.
Documentation: Record methods, validation data for non-standard methods, unique sample IDs, environmental monitoring, and test results. Nonconforming findings determine maximum shelf-life.

Practical applications

Establishing or justifying an IOL expiration date for labelling and regulatory submission.
Supporting material changes (new polymer, additives), packaging changes, sterilization process variations, or new lens–injector systems.
Demonstrating transport robustness for global distribution and supply-chain risk management.
Informing post-market surveillance and change control decisions.

Who should use this standard

IOL manufacturers (R&D, quality assurance, regulatory affairs)
Packaging engineers and supply-chain/transport specialists
Regulatory bodies and conformity assessment organizations
Medical device testing laboratories

Related standards

ISO 11979 series (Parts 1–10 - vocabulary, optical/mechanical tests, biocompatibility, labelling, clinical investigations)
ISO 14971 (risk management)
ISO 11607-1 / ISO 11607-2 (packaging for terminally sterilized medical devices)
ISO 10993-5, ISO 10993-12 (biological evaluation and extraction/sample preparation)

Keywords: ISO 11979-6, intraocular lenses, IOL shelf-life, transport stability testing, IOL packaging integrity, accelerated aging, real-time stability, extractables, cytotoxicity, medical device stability.

Технические детали

Технический комитет: ISO/TC 172/SC 7 - Ophthalmic optics and instruments
SKU: ISO 11979-6:2014

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ISO 11979-6:2014 PDF

Abstract

Overview - ISO 11979-6:2014 (Shelf-life and transport stability testing)

Похожие стандарты

Key topics and technical requirements

Practical applications

Who should use this standard

Related standards

Технические детали

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

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ISO 11607-2:2019/Amd 1:2023

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ISO 10993-5:2009

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SIST EN ISO 10993-1:2026

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SIST EN ISO 11979-6:2015

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