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
