Ophthalmic optics — Contact lenses and contact lens care products — Guidance for clinical investigations

Available format(s)

Hardcopy , PDF , PDF 3 Users , PDF 5 Users , PDF 9 Users

Language(s)

French, English

Published date

11-14-2012

Publisher

International Organization for Standardization

ISO 11980:2012 gives guidelines for the clinical investigation of the safety and performance of contact lenses and contact lens care products.

DevelopmentNote	Supersedes ISO/DIS 11980. (11/2012)
DocumentType	Standard
Pages	27
ProductNote	THIS STANDARD ALSO HAVE CORRECT VERSION FOR EN:2012
PublisherName	International Organization for Standardization
Status	Current
Supersedes	ISO 11980:2009

16/30310659 DC : 0	BS EN ISO 18369-2 - OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES
I.S. EN ISO 18369-2:2017	OPHTHALMIC OPTICS - CONTACT LENSES - PART 2: TOLERANCES (ISO 18369-2:2017)
BS EN ISO 14534:2015	Ophthalmic optics. Contact lenses and contact lens care products. Fundamental requirements
I.S. EN ISO 14534:2015	OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS (ISO 14534:2011)
09/30207531 DC : 0	BS EN ISO 14534 - OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - FUNDAMENTAL REQUIREMENTS
BS EN ISO 18369-2:2017	Ophthalmic optics. Contact lenses Tolerances
EN ISO 18369-2:2017	Ophthalmic optics - Contact lenses - Part 2: Tolerances (ISO 18369-2:2017)
ISO 18369-2:2017	Ophthalmic optics — Contact lenses — Part 2: Tolerances
DIN EN ISO 14534:2015-08	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
ISO 14534:2011	Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
UNE-EN ISO 14534:2015	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)
EN ISO 14534:2015	Ophthalmic optics - Contact lenses and contact lens care products - Fundamental requirements (ISO 14534:2011)

ISO 18369-1:2017	Ophthalmic optics — Contact lenses — Part 1: Vocabulary, classification system and recommendations for labelling specifications
ISO 14534:2011	Ophthalmic optics Contact lenses and contact lens care products Fundamental requirements
ISO 13485:2016	Medical devices Quality management systems Requirements for regulatory purposes
ISO 9001:2015	Quality management systems — Requirements
ISO 14155:2011	Clinical investigation of medical devices for human subjects Good clinical practice

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