BS EN ISO 11980:2012
Current
The latest, up-to-date edition.
Ophthalmic optics. Contact lenses and contact lens care products. Guidance for clinical investigations
Hardcopy , PDF
English
10-31-2013
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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 |
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 |
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.
| Standards | Relationship |
| ISO 1980:1977 | Identical |
| EN ISO 11980:2012 | Identical |
| NF EN ISO 11980 : 2013 | Identical |
| ISO 11980:2012 | Identical |
| NBN EN ISO 11980 : 2013 | Identical |
| UNE-EN ISO 11980:2013 | Identical |
| SN EN ISO 11980 : 2013 | Identical |
| NS EN ISO 11980 : 2012 | Identical |
| NEN EN ISO 11980 : 2012 | Identical |
| I.S. EN ISO 11980:2012 | Identical |
| UNI EN ISO 11980 : 2013 | Identical |
| DIN EN ISO 11980:2013-03 | Identical |
| 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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