ANSI Z80.11 : 2012 : R2017
Current
The latest, up-to-date edition.
OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
Hardcopy , PDF
English
01-01-2017
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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
Annex A - Spectral weighting function for ultraviolet radiation
hazard analysis
Annex B - Methods for system calibration
Annex C - Characterization of laser ablation beams and treatment
patterns
Annex D - Guidance on clinical study design of refractive
procedures that use laser systems for corneal reshaping
Annex E - Statistical sample size considerations
Annex F - Presentation of results of clinical studies
Annex G - Bibliography
Pertains 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.
| Committee |
Z80
|
| DocumentType |
Standard
|
| Pages |
51
|
| ProductNote |
Reconfirmed 2017
|
| PublisherName |
Optical Laboratories Association
|
| Status |
Current
|
| Supersedes |
| ISO 14155-2:2003 | Clinical investigation of medical devices for human subjects Part 2: Clinical investigation plans |
| IEC 60601-1:2005+AMD1:2012 CSV | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance |
| ISO 13852:1996 | Safety of machinery Safety distances to prevent danger zones being reached by the upper limbs |
| IEC 60825-1:2014 | Safety of laser products - Part 1: Equipment classification and requirements |
| CFR 21(PTS800-1299) : 0 | FOOD AND DRUGS - FOOD AND DRUG ADMINISTRATION, CHAPTER 1 DEPARTMENT OF HEALTH AND HUMAN SERVICES - PARTS 800-1299 |
| ISO 14155-1:2003 | Clinical investigation of medical devices for human subjects Part 1: General requirements |
| IEC 60601-2-22:2007+AMD1:2012 CSV | Medical electrical equipment - Part 2-22: Particular requirements for basic safety and essential performance of surgical, cosmetic, therapeutic and diagnostic laser equipment |
| IEC 60601-1-2:2014 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests |
| ANSI Z136.1 : 2014 | SAFE USE OF LASERS |
| IEC TR 60825-8:2006 | Safety of laser products - Part 8: Guidelines for the safe use of laser beams on humans |
| ISO 8612:2009 | Ophthalmic instruments — Tonometers |
| ISO 13853:1998 | Safety of machinery Safety distances to prevent danger zones being reached by the lower limbs |
| ISO 10936-2:2010 | Optics and photonics Operation microscopes Part 2: Light hazard from operation microscopes used in ocular surgery |
| ANSI Z136.3 : 2011 | SAFE USE OF LASERS IN HEALTH CARE |
| ISO 15004-2:2007 | Ophthalmic instruments Fundamental requirements and test methods Part 2: Light hazard protection |
| ISO 12100-2:2003 | Safety of machinery Basic concepts, general principles for design Part 2: Technical principles |
| ISO 13854:2017 | Safety of machinery — Minimum gaps to avoid crushing of parts of the human body |
| ISO 12100-1:2003 | Safety of machinery Basic concepts, general principles for design Part 1: Basic terminology, methodology |
| ISO 13850:2015 | Safety of machinery Emergency stop function Principles for design |
| ISO 14971:2007 | Medical devices Application of risk management to medical devices |
| IEC 60601-1-1:2000 | Medical electrical equipment - Part 1-1: General requirements for safety - Collateral standard: Safety requirements for medical electrical systems |
| ISO 13849-1:2015 | Safety of machinery — Safety-related parts of control systems — Part 1: General principles for design |
| IEC 60601-1-4:1996+AMD1:1999 CSV | Medical electrical equipment - Part 1-4: General requirements for safety - Collateral Standard: Programmable electrical medical systems |
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