Standard No.:	YY/T 0942-2014
English Name:	Ophthalmic optics―Injection system of intraocular lenses
Chinese Name:	眼科光学 人工晶状体植入系统
Chinese Classification:	C32    Ophthalmic and ENT surgical devices
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.70 11.040.70    Ophthalmic equipment 11.040.70
Issued by:	China Food and Drug Adminstration
Issued on:	2014-06-17
Implemented on:	2015-7-1
Status:	valid
Language:	English
File Format:	PDF
Word Count:	5500 words
Price(USD):	130.0
Delivery:	via email in 1 business day

1 Scope This standard specifies application scope, requirements, test method, marking and instruction for use, packaging, transport and storage for injection system of intraocular lenses. This standard is applicable to integrated (preloaded) or separated injection system of intraocular lenses (hereafter referred to as "injection system", including injector, cartridge, etc.). The injection system is intended to fold the intraocular lenses if possible and inject them into the lenses bag or ciliary groove after removing cataract or during the ocular refraction operation. 2 Normative References The following documents for the application of this document are essential. For dated reference, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies. GB/T 14233.1-2008 Test Methods for Infusion, Transfusion, Injection Equipments for Medical Use—Part 1: Chemical Analysis Methods GB/T 14233.2-2005 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 2: Biological Test Methods GB/T 14486-2008 Dimensional Tolerances for Moulded Plastic Parts GB 15810-2001 Sterile Hypodermic Syringes for Single Use GB/T 16886 (all parts) Biological Evaluation of Medical Devices YY/T 0149 Medical Instruments of Stainless Steel-Test Methods of Corrosion Resistance YY 0290.3-2008 Ophthalmic Implants—Intraocular Lenses—Part 3: Mechanical Properties and Test Methods YY/T 0313 Package, Lable, Transport and Storage for Medical Polymer Products YY/T 0466.1 Medical Devices - Symbols to be Used with Medical Device Labels Labelling and Information to be Supplied - Part 1: General Requirements 3 Terms and Definitions For the purposes of this document, the following terms and definitions apply.

Foreword i 1 Scope 2 Normative References 3 Terms and Definitions 4 Requirements 5 Test Methods 6 Instructions for Use 7 Labels 8 Packaging Annex A (Normative) Measurement of Axis Deviation