Поиск

Ophthalmic implants — Intraocular lenses. Labelling and information.

Ophthalmic implants. Intraocular lenses. Optical properties and test methods.

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2026)

Overview SIST EN ISO 11979-1:2026 sets forth standardized terminology for intraocular lenses (IOLs), a crucial category of ophthalmic implants. This international standard, developed by CEN in collab…

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2026)

Overview SIST EN ISO 11979-4:2026, Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information sets out the standardized requirements for labelling intraocular lenses (IOLs) and defi…

Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary (ISO 11979-1:2026)

Overview EN ISO 11979-1:2026 sets forth standardized terminology for intraocular lenses (IOLs), a crucial category of ophthalmic implants. This international standard, developed by CEN in collaborati…

Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information (ISO 11979-4:2026)

Overview EN ISO 11979-4:2026, Ophthalmic implants - Intraocular lenses - Part 4: Labelling and information sets out the standardized requirements for labelling intraocular lenses (IOLs) and defining…

Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2024)

Overview EN ISO 11979-2:2024 (published by CEN, identical to ISO 11979-2:2024) defines the optical properties and test methods for intraocular lenses (IOLs). The standard covers monofocal, toric, sim…

Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods (ISO 11979-2:2024)

Overview EN ISO 11979-2:2024 (published by CEN, identical to ISO 11979-2:2024) defines the optical properties and test methods for intraocular lenses (IOLs). The standard covers monofocal, toric, sim…

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the corr…

Overview EN ISO 11979-7:2024 (ISO 11979-7:2024) defines the particular requirements for clinical investigations of intraocular lenses (IOLs) implanted to correct aphakia. This fifth edition (publishe…

Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the corr…

Overview EN ISO 11979-7:2024 (ISO 11979-7:2024) defines the particular requirements for clinical investigations of intraocular lenses (IOLs) implanted to correct aphakia. This fifth edition (publishe…

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

Overview EN ISO 11979-5:2020 - "Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility" (CEN adoption of ISO 11979-5:2020) specifies requirements and guidance for the biological evaluati…

Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility (ISO 11979-5:2020)

Overview EN ISO 11979-5:2020 - "Ophthalmic implants - Intraocular lenses - Part 5: Biocompatibility" (CEN adoption of ISO 11979-5:2020) specifies requirements and guidance for the biological evaluati…

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correct…

Overview SIST EN ISO 11979-10:2018, titled Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes, is an internat…

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correct…

Overview EN ISO 11979-10:2018 (ISO 11979-10:2018) - "Ophthalmic implants - Intraocular lenses - Part 10" specifies clinical-investigation requirements for phakic intraocular lenses (IOLs) implanted i…

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

Overview EN ISO 11979-8:2017 - "Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements" defines the fundamental safety and performance expectations for intraocular lenses (IOLs)…

Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements (ISO 11979-8:2017)

Overview EN ISO 11979-8:2017 - "Ophthalmic implants - Intraocular lenses - Part 8: Fundamental requirements" defines the fundamental safety and performance expectations for intraocular lenses (IOLs)…

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

Overview EN ISO 11979-6:2014 - "Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing" specifies how to determine the shelf-life and transport stability of ste…

Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing (ISO 11979-6:20…

Overview EN ISO 11979-6:2014 - "Ophthalmic implants - Intraocular lenses - Part 6: Shelf-life and transport stability testing" specifies how to determine the shelf-life and transport stability of ste…

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

Overview EN ISO 11979-3:2012 (Ophthalmic implants - Intraocular lenses - Part 3) defines required mechanical properties and test methods for intraocular lenses (IOLs) intended for implantation in the…

Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods (ISO 11979-3:2012)

Overview EN ISO 11979-3:2012 (Ophthalmic implants - Intraocular lenses - Part 3) defines required mechanical properties and test methods for intraocular lenses (IOLs) intended for implantation in the…

Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations

Ophthalmic implants — Intraocular lenses — Part 9: Multifocal intraocular lenses — Amendment 1

Ophthalmic implants — Intraocular lenses — Part 10: Phakic intraocular lenses — Amendment 1

Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information — Amendment 1

Overview ISO 11979-4:2008/Amd 1:2012 is an important international amendment to the ISO 11979-4 standard, focusing on ophthalmic implants, specifically intraocular lenses (IOLs). This amendment updat…

Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary

Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations — Amendment 1

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements — Amendment 1

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

Ophthalmic implants — Intraocular lenses — Part 10: Phakic intraocular lenses

Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements

Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations

Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements — Technical Corrigendum 1

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

Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations

Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information

Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods

Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary

Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility

Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements

Tracked Changes. Ophthalmic implants. Intraocular lenses. Vocabulary.

Tracked Changes. Ophthalmic implants. Intraocular lenses. Clinical investigations of intraocular lenses for c…

Tracked Changes. Ophthalmic implants. Intraocular lenses. Optical properties and test methods.

Tracked Changes. Ophthalmic implants. Intraocular lenses. Labelling and information.

Tracked Changes. Ophthalmic implants. Intraocular lenses. Clinical investigations of intraocular lenses for t…

Ophthalmic implants. Intraocular lenses - Mechanical properties and test methods

Ophthalmic implants. Intraocular lenses - Biocompatibility

BS EN ISO 11979-5:2006 follows the general principles given in ISO 10993-1. ISO 10993-1 and describes the principles governing the biological evaluation of medical devices, the definitions of categor…

Ophthalmic implants. Intraocular lenses - Optical properties and test methods

1 Scope This part of ISO 11979 specifies requirements and test methods for certain optical properties of intraocular lenses (IOLs) with any of spherical, aspheric, monofocal, toric, multifocal, and/o…

Ophthalmic implants. Intraocular lenses - Clinical investigations of intraocular lenses for the correction of…

1 Scope This document specifies the particular requirements for the clinical investigations of intraocular lenses that are implanted in the eye in order to correct aphakia.

Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements

Overview ISO 11979-8:2017 is an international standard that defines the fundamental requirements for intraocular lenses (IOLs) intended for surgical implantation in the anterior segment of the human…

Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods

Overview ISO 11979-3:2012 - "Ophthalmic implants - Intraocular lenses - Part 3: Mechanical properties and test methods" specifies required mechanical properties and laboratory test methods for intrao…

Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary

Overview ISO 11979-1:2018 - "Ophthalmic implants - Intraocular lenses - Part 1: Vocabulary" is the ISO vocabulary for intraocular lenses (IOLs) and the methods used to evaluate them. The document def…

Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information

Overview ISO 11979-4:2008 specifies labelling and information requirements for intraocular lenses (IOLs) - ophthalmic implants used in cataract and refractive surgery. The standard defines the minimu…

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

Overview - ISO 11979-6:2014 (Shelf-life and transport stability testing) ISO 11979-6:2014 specifies how to determine the shelf-life of sterile intraocular lenses (IOLs) in their final packaging and h…

Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods

Overview - ISO 11979-2:2024 (Intraocular lenses, optical properties and test methods) ISO 11979-2:2024 defines requirements and reference test methods for the optical properties of intraocular lenses…

Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information

Overview ISO 11979-4:2026 sets the international standard for labelling and information requirements for intraocular lenses (IOLs), which are medical devices implanted to replace the natural lens of…

Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods

Overview ISO 11979-2:2014 - "Ophthalmic implants - Intraocular lenses - Part 2: Optical properties and test methods" defines requirements and reference test methods for the optical performance of int…

Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the corr…

Overview ISO 11979-7:2024 - "Ophthalmic implants - Intraocular lenses - Part 7: Clinical investigations of intraocular lenses for the correction of aphakia" specifies the particular requirements for…