YY 0762-2017 English PDF (YY0762-2017)

This Standard specifies requirements, test methods, label, instruction of usage, package, transport and storage of capsular tension ring. This Standard is applicable to disposable capsular tension ring (hereinafter referred to as tension ring). Tension ring can be adopted to maintain capsular tension in aphakic eyes, prevent from posterior capsule wrinkles and fight against capsular contraction.

YY 0762-2017
YY
PHARMACEUTICAL INDUSTRY STANDARD
OF THE PEOPLE’S REPUBLIC OF CHINA
ICS 11.040.70
C 40
Replacing YY 0762-2009
Ophthalmic Optical - Capsular Tension Ring
眼科光学 囊袋张力环
ISSUED ON. JULY 17, 2017
IMPLEMENTED ON. JULY 1, 2018
Issued by. China Food and Drug Administration
Table of Contents
Foreword ... 3
1 Scope ... 4
2 Normative References ... 4
3 Terms and Definitions ... 5
4 Requirements ... 6
5 Test Methods ... 9
6 Label and Instruction of Usage ... 12
7 Package, Transport and Storage ... 13
Ophthalmic Optical - Capsular Tension Ring
1 Scope
This Standard specifies requirements, test methods, label, instruction of usage, package, transport and storage of capsular tension ring.
This Standard is applicable to disposable capsular tension ring (hereinafter referred to as tension ring). Tension ring can be adopted to maintain capsular tension in aphakic eyes, prevent from posterior capsule wrinkles and fight against capsular contraction. 2 Normative References
The following documents are indispensable to the application of this Standard. In terms of references with a specified date, only versions with a specified date are applicable to this Standard. The latest version (including all the modifications) of references without a specified date is also applicable to this Standard.
GB/T 9969 General Principles for Preparation of Instructions for Use of Industrial Products
GB/T 14233.1 Test Methods for Infusion, Transfusion, Injection Equipment for Medical Use - Part 1. Chemical Analysis Methods
GB/T 16886.5 Biological Evaluation of Medical Devices - Part 5. Test for in Vitro Cytotoxicity
GB/T 16886.10 Biological Evaluation of Medical Devices - Part 10. Tests for Irritation and Delayed-type Hypersensitivity
GB/T 16886.12 Biological Evaluation of Medical Devices - Part 12. Sample Preparation and Reference Materials
YY 0290.3-2008 Ophthalmic Implants - Intraocular Lenses - Part 3. Mechanical Properties and Test Methods
YY 0290.5-2008 Ophthalmic Implants - Intraocular Lenses - Part 5.
Biocompatibility
YY 0290.6 Intraocular Lenses - Part 6. Shelf-life and Transport Stability Pharmacopoeia of the People’s Republic of China
Except from primary packaging, additional wrapping maintains sterility performance. 3.6 Storage Container
Storage container is a package that has protective effect during the storage and sales. 3.7 Prescription Diameter
Prescription diameter is anticipated implantation diameter issued by clinical practitioners that’s suitable for patients.
4 Requirements
4.1 Mechanical Performance
4.1.1 Functional elasticity
4.1.1.1 Nominal value tolerance of functional elasticity
Manufacturers shall provide the nominal value of functional elasticity of tension ring. The functional elasticity shall be radial deformation force that’s generated when symmetrical position of the tension ring reaches the prescribed diameter through radial deformation. The nominal value tolerance of functional elasticity shall be ± 10%. 4.1.1.2 Functional elasticity attenuation
Manufacturers shall provide yield characteristics when the tension ring reaches the prescribed diameter through radial deformation and maintains for 24 h under the state of clinical application. The yield characteristics can be represented by the proportion of functional elasticity attenuation or the proportion of deformation of the maximum peripheral diameter after compression and release.
4.1.2 Shape variable and stress
4.1.2.1 Elasticity limit
Materials of tension ring shall be uniform; the processing of tension ring shall be flawless. After tension ring experiences the following deformation tests, there are abnormal deformations triggered by the deficiency of concentrated stress. The following requirements shall be satisfied simultaneously under room temperature. a) Impose radial force onto the tension ring in accordance with the symmetrical position. When compression reaches 50% shape variable, immediately release it. The variation of the maximum peripheral diameter shall be ≤ 1% of original value;
b) Impose force onto both sides of the tension ring along the peripheral axis The surface of tension ring shall be smooth; the transition areas shall be successive; there shall be no defects that might cause human tissue damage.
4.4 Extraction
Conduct 0.9% NaCl inorganic solvent extraction test on the tension ring; the rate of extraction shall be < 0.5%.
4.5 Biocompatibility
4.5.1 General principles
Materials with verified conformity with biocompatibility shall be adopted to manufacture tension rings, otherwise, materials shall be verified through tests described in 4.5.2 ~ 4.5.5.
4.5.2 Cytotoxicity
No cytotoxicity shall be found in finished tension rings.
4.5.3 Eye irritation
No eye irritation shall be triggered by finished tension rings.
4.5.4 Delayed-type hypersensitivity
No delayed-type hypersensitivity shall be triggered by finished tension rings. 4.5.5 Intraocular implantation test
If manufacturers cannot provide documents to prove material safety of tension ring under intraocular environment, intraocular implantation test shall be conducted; compatibility between test materials and intraocular tissues shall be evaluated after the implantation.
4.6 Sterility
The sterility of tension rings shall be maintained before the expiration date indicated by the label.
4.7 Ethylene Oxide Residue
If ethylene oxide is adopted for sterilization, ethylene oxide residue shall be ≤ 10 mg/kg. 4.8 Validity Period
The performance of tension rings shall satisfy the requirements within the validity period.
5.1.3 Uniformity check
Instrument. projector.
Steps. take 10 tension rings; respectively select 5 points on each sample for measurement.
5.1.4 Dynamic fatigue durability test
Take 3 tension rings, conduct dynamic fatigue durability test in normal saline solution in accordance with the principle of equipment described in Appendix G in YY 0290.3- 2008.
5.2 Dimension Measurement
Adopt measuring instrument for dimension measurement.
5.3 Surface Quality Check
Adopt optical microscope (above 10x) to check surface quality.
5.4 Extraction Test
Conduct extraction test in accordance with the method described in Appendix B in YY 0290.5-2008.
5.5 Biocompatibility Test
5.5.1 Cytotoxicity test
Test solution shall be prepared in accordance with the method described in GB/T 16886.12; conduct cytotoxicity test in accordance with the method stipulated in GB/T 16886.5.
5.5.2 Eye irritation test
Test solution shall be prepared in accordance with the method described in GB/T 16886.12; conduct eye irritation test in accordance with the method stipulated in GB/T 16886.10.
5.5.3 Delayed-type hypersensitivity test
Test solution shall be prepared in accordance with the method described in GB/T 16886.12; conduct delayed-type hypersensitivity test in accordance with the method stipulated in GB/T 16886.10.
5.5.4 Intraocular implantation test
Conduct applicability test in accordance with the method described in Appendix G in