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ANSI Z80.11-2012 laser systems for corneal reshaping

Standard Number:  ANSI Z80.11-2012
Title:  laser systems for corneal reshaping
Language:  English
Publication Date:  2012/8/9
Execute Date:  2012/8/9
Status:  Current
International Classification for Standards (ICS)HEALTH CARE TECHNOLOGY>>Medical equipment>>Ophthalmic equipment
Publisher:  American Nuclear Society Specificatioin
Price:  
Number of Pages:51  

Description:THIS STANDARD APPLIES TO ANY LASER SYSTEM WHOSE PRIMARY INTENDED USE IS TO ALTER THE SHAPE OF THE CORNEA THROUGH THE REMOVAL OF CORNEAL TISSUE, RESULTING IN THE IMPROVEMENT OF VISUAL PERFORMANCE. THIS STANDARD ADDRESSES THE VOCABULARY, PERFORMANCE REQUIRE  
Catalog:Foreword
1 Scope and purpose
2 Normative references
3 Definitions
4 Mechanical, thermal, and environmental requirements
5 Safety requirements
6 Optical requirements
7 System control and performance
8 Clinical evaluation
9 Test methods
10 Accompanying documents
11 Marking
Annexes
A - Spectral weighting function for ultraviolet radiation
hazard analysis
B - Methods for system calibration
C - Characterization of laser ablation beams and treatment
patterns
D - Guidance on clinical study design of refractive
procedures that use laser systems for corneal reshaping
E - Statistical sample size considerations
F - Presentation of results of clinical studies
G - Bibliography  
File Format:  PDF(Acrobat Reader) or Word version doc Document
File Size:  378KB
Tile in English:  laser systems for corneal reshaping

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