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BS 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
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

31-10-2013

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.

This International Standard gives guidelines for the clinical investigation (CI) of the safety and performance of contact lenses and contact lens care products.

NOTE This International Standard attempts to harmonize the recognized 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 International Standard.

Committee
CH/172/9
DevelopmentNote
Supersedes BS 7208-3(1992) and 95/563409 DC (08/2004) Supersedes BS 7208-16(1998) and 08/30138762 DC. (11/2009)
DocumentType
Standard
Pages
36
PublisherName
British Standards Institution
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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