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DIN EN ISO 11980

Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)

active, Most Current
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Organization: DIN
Publication Date: 1 March 2013
Status: active
Page Count: 32
ICS Code (Ophthalmic equipment): 11.040.70
scope:

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.

Document History

DIN EN ISO 11980
March 1, 2013
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2012)
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...
March 1, 2010
Ophthalmic optics - Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:2009)
A description is not available for this item.
February 1, 1998
Contact lenses and contact lens care products - Guidance for clinical investigations (ISO 11980:1997)
A description is not available for this item.

References

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