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ANSI Z80.13 : 2007 : R2017
Current
The latest, up-to-date edition.
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OPHTHALMICS - PHAKIC INTRAOCULAR LENSES
Hardcopy , PDF
English
01-01-2017
Foreword
1 Scope and purpose
2 Normative references
3 Definitions
4 Physical requirements
5 Optical requirements
6 Mechanical requirements
7 Biocompatibility requirements
8 Sterility/package integrity requirements
9 Shelf-life and transport stability
10 Clinical investigation plan
11 Labeling
Annexes
Annex A - Mechanical characterization and testing
of phakic IOLs
Annex B - Non-ocular implantation test
Annex C - Ocular implantation test
Annex D - Clinical guidance
Annex E - Statistical sample size considerations
Annex F - Bibliography
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