I.S. EN ISO 11980:2012
Current
The latest, up-to-date edition.
OPHTHALMIC OPTICS - CONTACT LENSES AND CONTACT LENS CARE PRODUCTS - GUIDANCE FOR CLINICAL INVESTIGATIONS (ISO 11980:2012)
Hardcopy , PDF
English
01-01-2012
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.
Dates of withdrawal of national standards are available from NSAI.
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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.
| DocumentType |
Standard
|
| Pages |
41
|
| PublisherName |
National Standards Authority of Ireland
|
| Status |
Current
|
| Supersedes |
| Standards | Relationship |
| BS EN ISO 11980:2012 | 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 |
| 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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