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YY/T 0942-2014 English PDF

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YY/T 0942-2014: Ophthalmic optics. Injection system of intraocular lenses
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YY/T 0942-2014English229 Add to Cart 3 days [Need to translate] Ophthalmic optics. Injection system of intraocular lenses Valid YY/T 0942-2014

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Standard similar to YY/T 0942-2014

GA 36   YY/T 0980.1   GB/T 1962.1   YY/T 0290.4   YY/T 0180   YY/T 0176.9   

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

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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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