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I.S. EN ISO 11980:2012

Current
Current

The latest, up-to-date edition.

OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS (ISO 11980:2012)
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2012

Publisher

National Standards Authority of Ireland

Preview

For Harmonized Standards, check the EU site to confirm that the Standard is cited in the Official Journal.

Only cited Standards give presumption of conformance to New Approach Directives/Regulations.

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.

DocumentType
Standard
Pages
41
PublisherName
National Standards Authority of Ireland
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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Hardcopy - English
PDF - English
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