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ANSI Z80.11 : 2012 : R2017

Current
Current

The latest, up-to-date edition.

OPHTHALMICS - LASER SYSTEMS FOR CORNEAL RESHAPING
Available format(s)

Hardcopy , PDF

Language(s)

English

Published date

01-01-2017

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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