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STANDARD

Current

ÖNORM EN ISO 11980

Issue date: 2025 12 01

Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for clinical investigations (ISO 11980:2025)

This document gives requirements and guidelines for the clinical investigation (CI) to establish the safety and performance of contact lenses and contact lens care products. NOTE 1        This document attempts to align the recognised regulatory requirements for the conduct of a CI to meet the marketing and labelling requirements for contact lenses and contact lens care products around the world. However, national requirements vary greatly. Wherever national practice or regulations dictate some legal requirement, this requirement takes precedence over this document. NOTE 2        For indications beyond correction of refractive error, additional considerations for safety and performance are to be included in the clinical investigation plan (CIP).

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General information on ÖNORM EN ISO 11980

Format

Paper | 45 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 11980 from 1998 til today.

• ÖNORM EN ISO 11980

  2025 12 01 Standard ÖNORM EN ISO 11980, Edition: 2025 12 01

  Ophthalmic optics - Contact lenses and contact lens care products - Requirements and guidance for cl...
• ÖNORM EN ISO 11980

  2013 03 15 Standard ÖNORM EN ISO 11980, Edition: 2013 03 15

  Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigat...
• ÖNORM EN ISO 11980

  2010 02 15 Standard ÖNORM EN ISO 11980, Edition: 2010 02 15

  Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigat...
• ÖNORM EN ISO 11980

  1998 05 01 Standard ÖNORM EN ISO 11980, Edition: 1998 05 01

  Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigat...

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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 14155:2020	Titel Clinical investigation of medical devices for human subjects — Good clinical practice	Ausgabedatum 2020 07 28	Art Standard	Zur Produktseite
Dokumentnummer ISO 14534:2011	Titel Ophthalmic optics — Contact lenses and contact lens care products — Fundamental requirements	Ausgabedatum 2011 03 22	Art Standard	Zur Produktseite
Dokumentnummer ISO 18369-1:2017	Titel Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications (Corrected version 2017-11)	Ausgabedatum 2017 08 23	Art Standard	Zur Produktseite

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