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| YY/T 0942-2014 | English | 229 |
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Ophthalmic optics. Injection system of intraocular lenses
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YY/T 0942-2014
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Basic data | Standard ID | YY/T 0942-2014 (YY/T0942-2014) | | Description (Translated English) | Ophthalmic optics. Injection system of intraocular lenses | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard (Recommended) | | Classification of Chinese Standard | C32 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 10,153 | | Date of Issue | 6/17/2014 | | Date of Implementation | 7/1/2015 | | Quoted Standard | GB/T 14233.1-2008; GB/T 14233.2-2005; GB/T 14486-2008; GB 15810-2001; GB/T 16886.14; GB/T 16886.13; GB/T 16886.12; GB/T 16886.10; GB/T 16886.16; GB/T 16886.5; GB/T 16886.4; GB/T 16886.3; GB/T 16886.17; GB/T 16886.15; GB/T 16886.19; GB/T 16886.2; GB/T 1688 | | Regulation (derived from) | China Food and Drug Administration in 2014 Bulletin No. 30 | | Issuing agency(ies) | State Food and Drug Administration | | Summary | This Standard applies to in-one (pre-installed) or separate IOL implantation system (hereinafter referred to as implant systems: Contains bolus device, imported top parts). Implanted after cataract extraction system for foldable intraocular lens or lens c |
YY/T 0942-2014: Ophthalmic optics. Injection system of intraocular lenses---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order.
Ophthalmic optics.Injection system of intraocular lenses
ICS 11.040.70
C32
People's Republic of China pharmaceutical industry standards
Ophthalmic optics IOL implantation system
Issued on. 2014-06-17
2015-07-01 implementation
China Food and Drug Administration released
Foreword
This standard was drafted in accordance with GB/T 1.1-2009 given rules.
Please note that some of the content of this document may involve patents. Distribution of this document
Institutions do not assume the responsibility to identify these patents.
This standard was proposed by the China Food and Drug Administration.
This standard by the national medical and optical instruments Standardization Technical Committee (SAC/TC103/SC1) centralized.
This standard was drafted. Zhejiang Medical Device Testing Institute, the State Food and Drug Administration Medical Device Quality Supervision, Inspection and Hangzhou
center.
The main drafters of this standard. Feng Qin, JIA Xiao Hang, Chen flowers, Yu Chongqing, all week.
Ophthalmic optics IOL implantation system
1 Scope
This standard specifies the scope of application of artificial lens implantation systems, requirements, test methods, marking and instructions for use, packaging, transport and
Storage.
This standard applies to in-one (pre-installed) or separate IOL implantation system (hereinafter referred to as implant system. Contains bolus, a guide
The top member). Implant system used after cataract or refractive surgery will be folded and foldable IOL implantation crystalline
Body capsular bag or ciliary sulcus.
2 Normative references
The following documents for the application of this document is essential. For dated references, only the dated version suitable for use herein
Member. For undated references, the latest edition (including any amendments) applies to this document.
GB/T 14233.1-2008 Infusion, transfusion, injection equipment - Part 1. Chemical analysis
GB/T 14233.2-2005 Infusion, transfusion, injection equipment test methods - Part 2. Biological test methods
GB/T 14486-2008 plastic molding dimensional tolerances
GB 15810-2001 disposable sterile syringes
Biological evaluation of GB/T 16886 (all parts) Medical Devices
YY/T 0149 stainless steel medical equipment corrosion test methods
YY 0290.3-2008 IOL optics Part 3. Mechanical properties and test methods
YY/T 0313 Medical Polymer Co., packaging, labeling, transportation and storage
Symbols - Part 1 YY/T 0466.1 medical equipment used with medical device labels, labeling and information. General requirements
3 Terms and Definitions
The following terms and definitions apply to this document.
3.1
Import head cartridge
Having a mounting groove and folding IOL bolus passage of surgical instruments.
3.2
Bolus injector device
For pushing the folded intraocular lens into the eye of the surgical instrument may be reusable or disposable.
NOTE. Importing head and bolus can be integrated as a fixed structure, may also be a separate structure.
3.3
Bolus passage injectionchannel
IOL and move out of the pipe portion of the implant system port before under thrust.
3.4
Advance stroke injectioncourse
Putted from the state to the fully retracted position of the distance up.
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