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STANDARD

Current

ÖNORM EN ISO 11979-10

Issue date: 2018 10 01

Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses for correction of ametropia in phakic eyes (ISO 11979-10:2018)

This document specifies requirements for any intraocular lenses to be implanted in the anterior segment of the eye with the primary indication to modify its refractive power. There are three main categories of phakic intraocular lenses depending on the optical design: a) Phakic monofocal (PIOL); b) Phakic multifocal (PMIOL); and c) Phakic toric (PTIOL). Each of these categories is further designated for implantation in either the anterior or posterior chamber of the anterior segment of the eye. The basic phakic IOL requirements apply to all the types. Additional requirements apply to PMIOL and PTIOL designs. This document addresses specific clinical requirements for phakic IOLs that are not addressed in the other parts of ISO 11979.

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General information on ÖNORM EN ISO 11979-10

Format

Paper | 24 Pages

Language

German | English | Download GER/ENG

Publisher

Austrian Standards International

Committee 047 Optics, optical instruments and lighting

Timeline

An overview of the development of ÖNORM EN ISO 11979-10 from 2006 til today.

• ÖNORM EN ISO 11979-10

  2018 10 01 Standard ÖNORM EN ISO 11979-10, Edition: 2018 10 01

  Ophthalmic implants - Intraocular lenses - Part 10: Clinical investigations of intraocular lenses fo...
• ÖNORM EN ISO 11979-10

  2014 12 01 Standard ÖNORM EN ISO 11979-10, Edition: 2014 12 01

  Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006 + A...
• ÖNORM EN ISO 11979-10

  2006 11 01 Standard ÖNORM EN ISO 11979-10, Edition: 2006 11 01

  Ophthalmic implants - Intraocular lenses - Part 10: Phakic intraocular lenses (ISO 11979-10:2006)

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Normative References

Here you will find an extract of the normative references. Please refer to the document itself for the full list.

Dokumentnummer	Titel	Ausgabedatum	Art	Link
Dokumentnummer ISO 11979-1:2018	Titel Ophthalmic implants — Intraocular lenses — Part 1: Vocabulary	Ausgabedatum 2018 11 14	Art Standard	Zur Produktseite
Dokumentnummer ISO 11979-2:2014	Titel Ophthalmic implants — Intraocular lenses — Part 2: Optical properties and test methods	Ausgabedatum 2014 08 12	Art Standard	Zur Produktseite
Dokumentnummer ISO 11979-3:2012	Titel Ophthalmic implants — Intraocular lenses — Part 3: Mechanical properties and test methods	Ausgabedatum 2012 12 06	Art Standard	Zur Produktseite
Dokumentnummer ISO 11979-4:2008	Titel Ophthalmic implants — Intraocular lenses — Part 4: Labelling and information	Ausgabedatum 2008 11 17	Art Standard	Zur Produktseite
Dokumentnummer ISO 11979-5:2020	Titel Ophthalmic implants — Intraocular lenses — Part 5: Biocompatibility	Ausgabedatum 2020 09 24	Art Standard	Zur Produktseite
Dokumentnummer ISO 11979-6:2014	Titel Ophthalmic implants — Intraocular lenses — Part 6: Shelf-life and transport stability testing	Ausgabedatum 2014 09 24	Art Standard	Zur Produktseite
Dokumentnummer ISO 11979-7:2018	Titel Ophthalmic implants — Intraocular lenses — Part 7: Clinical investigations of intraocular lenses for the correction of aphakia	Ausgabedatum 2018 03 23	Art Standard	Zur Produktseite
Dokumentnummer ISO 11979-8:2017	Titel Ophthalmic implants — Intraocular lenses — Part 8: Fundamental requirements	Ausgabedatum 2017 04 12	Art Standard	Zur Produktseite
Dokumentnummer ISO 14155:2020	Titel Clinical investigation of medical devices for human subjects — Good clinical practice	Ausgabedatum 2020 07 28	Art Standard	Zur Produktseite
Dokumentnummer ISO 14971:2019	Titel Medical devices — Application of risk management to medical devices	Ausgabedatum 2019 12 10	Art Standard	Zur Produktseite

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