1 Scope
This standard specifies terms and definitions, structures and basic parameters, requirements, test methods, inspection rules as well as marking, packaging, transportation and storage of excimer laser cornea ametropia cure system.
This standard is applicable to excimer laser cornea ametropia cure system (hereinafter referred to as cure system) which adopts 193nm excimer laser to remove cornea tissue and change the shape of cornea so as to improve eyesight and is mainly used for cornea dioptric rectification and photo therapeutic keratectomy (PTK) like photorefractive keratectomy (PRK) and laser assisted in-situ keratomi leusis (LASIK).
2 Normative References
The following referenced documents are indispensable for the application of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 191 Packaging - Pictorial Marking for Handling of Goods
GB 7247.1 Safety of Laser Products - Part 1: Equipment Classification and Requirements
GB 9706.1 Medical Electrical Equipment - Part 1: General Requirements for Safety
GB 9706.20 Medical Electrical Equipment - Part 2: Particular Requirements for the Safety of Diagnostic and Therapeutic Laser Equipment
GB 11239.1-2005 Operation Microscopes
GB/T 14710 Environmental Requirements and Test Methods for Medical Electrical Equipment
GB/T 17736 Testing Method of Main Parameters for Laser Protective Eyewear
YY 91057-1999 General Specifications for Medical Foot Switch
ISO 10936-2 Optics and Photonics - Operation Microscopes - Part 2: Light Hazard from Operation Microscopes Used in Ocular Surgery
ISO 15004-2 Ophthalmic Instruments - Fundamental Requirements and Test Methods - Part 2: Light Hazard Protection
ANSI Z80.11-2007 Ophthalmics - Laser System for Corneal Reshaping
3 Definitions and Terms
Foreword i
1 Scope
2 Normative References
3 Definitions and Terms
4 Product Composition and Basic Parameters
5 Requirements
6 Test Methods
7 Inspection Rules
8 Mark, Label and Use Instructions
9 Packaging, Transportation and Storage
