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Position: Chinese Standard in English/YY 0599-2015
YY 0599-2015   Therapeutic laser equipment―Excimer laser cornea ametropia cure system (English Version)
Standard No.: YY 0599-2015 Status:to be superseded remind me the status change

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Language:English File Format:PDF
Word Count: 6000 words Price(USD):150.0 remind me the price change

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Implemented on:2017-1-1 Delivery: via email in 1 business day
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Standard No.: YY 0599-2015
English Name: Therapeutic laser equipment―Excimer laser cornea ametropia cure system
Chinese Name: 激光治疗设备 准分子激光角膜屈光治疗机
Chinese Classification: C42    Physiotherapy and TCM instrument and equipment
Professional Classification: YY    Professional Standard - Pharmaceutics
ICS Classification: 11.040.60 11.040.60    Therapy equipment 11.040.60
Issued by: China Food and Drug Adminstration
Issued on: 2015-03-02
Implemented on: 2017-1-1
Status: to be superseded
Superseded by:YY 0599-2024 Laser therapeutic equipment - Excimer laser cornea ametropia equipment
Superseded on:2027-7-20
Superseding:YY 0599-2007 Excimer laser cornea ametropia cure system
Language: English
File Format: PDF
Word Count: 6000 words
Price(USD): 150.0
Delivery: via email in 1 business day
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
Referred in YY 0599-2015:
*GB/T 191-2008 Packaging - Pictorial Marking for Handling of Goods
*GB 7247.1-2012 Safety of laser products—Part 1:Equipment classification and requirements
*GB 9706.1-2007 Medical electrical equipment—Part 1:General requirements for safety
*GB 9706.20-2000 Medical electrical equipment--Part 2:Particular requirements for the safety of diagnostic and therapeutic laser equipment
*GB 11239.1-2005 Operation microscopes Part1: Requirements and test methods
*GB/T 14710-2009 Environmental requirement and test methods for medical electrical equipment
*GB/T 17736-1999 Testing method of main parameters for laser protective eyewear
*YY 91057-1999 General specifications for medical foot switch
Code of China
Standard
YY 0599-2015  Therapeutic laser equipment―Excimer laser cornea ametropia cure system (English Version)
Standard No.YY 0599-2015
Statusto be superseded
LanguageEnglish
File FormatPDF
Word Count6000 words
Price(USD)150.0
Implemented on2017-1-1
Deliveryvia email in 1 business day
Detail of YY 0599-2015
Standard No.
YY 0599-2015
English Name
Therapeutic laser equipment―Excimer laser cornea ametropia cure system
Chinese Name
激光治疗设备 准分子激光角膜屈光治疗机
Chinese Classification
C42
Professional Classification
YY
ICS Classification
Issued by
China Food and Drug Adminstration
Issued on
2015-03-02
Implemented on
2017-1-1
Status
to be superseded
Superseded by
YY 0599-2024 Laser therapeutic equipment - Excimer laser cornea ametropia equipment
Superseded on
2027-7-20
Abolished on
Superseding
YY 0599-2007 Excimer laser cornea ametropia cure system
Language
English
File Format
PDF
Word Count
6000 words
Price(USD)
150.0
Keywords
YY 0599-2015, YY/T 0599-2015, YYT 0599-2015, YY0599-2015, YY 0599, YY0599, YY/T0599-2015, YY/T 0599, YY/T0599, YYT0599-2015, YYT 0599, YYT0599
Introduction of YY 0599-2015
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
Contents of YY 0599-2015
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
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