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UNI EN ISO 11980 : 2013

Current

Current

The latest, up-to-date edition.

OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS

Published date

10-01-2013

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Foreword
Introduction
1 Scope
2 Normative references
3 Terms and definitions
4 Clinical investigational requirements
Annex A (informative) - Elements of a clinical
        investigation
Annex B (informative) - Procedures for the evaluation
        of safety, physiological
        performance and effect on
        ocular tissues
Annex C (informative) - The evaluation of visual,
        refractive and lens performance
        and subject acceptance
Bibliography

Provides guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products.

Committee
CT 44
DocumentType
Standard
PublisherName
Ente Nazionale Italiano di Unificazione (UNI)
Status
Current
Supersedes

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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