YY 0762-2017 English PDF (YY0762-2017)

Delivery: 3 seconds. Download true-PDF + Invoice.
Get Quotation: Click YY 0762-2017 (Self-service in 1-minute)
Historical versions (Master-website): YY 0762-2017
Preview True-PDF (Reload/Scroll-down if blank)

YY 0762-2017: Ophthalmic Optical - Capsular Tension Ring
YY 0762-2017
Ophthalmic optical -- Capsular tension ring
ICS 11.040.70
C40
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0762-2009
Ophthalmic optical bag tension ring
Released on.2017-07-17
2018-07-01 implementation
State Food and Drug Administration issued
Foreword
The full technical content of this standard is mandatory.
This standard was drafted in accordance with the rules given in GB/T 1.1-2009.
This standard replaces YY 0762-2009 "Ophthalmic optical pouch tension ring", this standard is compared with YY 0762-2009, except for editorial
The main technical changes outside the revision are as follows.
---Modified normative references;
--- Modified 3.1 in terms and definitions;
--- Revised material biocompatibility, functional elasticity, uniformity, size, extraction, sterilization requirements;
---Modified functional elastic test, deformation and stress measurement, extraction test, ophthalmic implant test, sterility test method;
---Modified the label and instruction manual;
--- Increased the yield limit test method;
--- Increased standards for preparation of test solutions for biocompatibility testing.
Please note that some of the contents of this document may involve patents. The issuing organization of this document is not responsible for identifying these patents.
This standard was proposed by the State Food and Drug Administration.
This standard is under the jurisdiction of the National Technical Committee for Standardization of Medical Optical Instruments (SAC/TC103/SC1).
This standard was drafted. Zhejiang Medical Device Inspection Institute.
The main drafters of this standard. Zhang Li, Feng Qin, Chen Xianhua, Wen Yan, Zheng Jian, Jia Xiaohang, Wang Minzhu, Xia Zhong.
The previous versions of the standards replaced by this standard are.
---YY 0762-2009.
Ophthalmic optical bag tension ring
1 Scope
This standard specifies the requirements, test methods, signs and instructions for use, packaging, transportation and storage of the bag tension ring.
This standard applies to disposable bag tension ring (hereinafter referred to as tension ring). Tension ring for aphakic eye to maintain capsular tension, prevent
The posterior capsule folds against the contraction of the capsular bag.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only dated versions apply to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
GB/T 9969 General guidelines for the use of industrial products
GB/T 14233.1 Medical infusion, blood transfusion, and injecting machines - Test methods - Part 1
GB/T 16886.5 Biological evaluation of medical devices - Part 5. In vitro cytotoxicity test
GB/T 16886.10 Biological evaluation of medical devices - Part 10. Stimulation and delayed hypersensitivity test
GB/T 16886.12 Biological evaluation of medical devices - Part 12. Sample preparation and reference
YY 0290.3-2008 Ophthalmic optical intraocular lenses - Part 3. Mechanical properties and test methods
YY 0290.5-2008 Ophthalmic optical intraocular lenses - Part 5. Biocompatibility
YY 0290.6 Ophthalmic optical intraocular lens Part 6. Effective period and transport stability
Chinese Pharmacopoeia
3 Terms and definitions
The following terms and definitions apply to this document.
3.1
Tension ring capsulartensionring
The tension ring is shown in Figure 1. It is applied to the subluxation of the ligament of the suspensory ligament, phacoemulsification and intraocular lens implantation and inhibition of posterior white
Barrier surgery and other cataract surgery.
Description.
1---tension ring;
2---positioning hole;
l---Maximum peripheral size.
Note. Figure 1 is only one example of a tension ring product.
Figure 1 Schematic diagram of the tension ring
3.2
Maximum peripheral size maximumperipheraldiameter
The largest outer dimension of the tension ring.
3.3
Positioning hole
A hole that is convenient or not accessible for clinical operation.
3.4
Original packaging primarypackaging
Physically protect the tension ring directly and maintain its sterile container.
3.5
Additional packaging additionalwrapping
An additional wrapper to maintain aseptic performance in addition to the original packaging.
3.6
Outer packaging storagecontainer
A package that protects during storage and sale.
3.7
Prescription diameter prescriptiondiameter
The expected implant diameter for the patient given by the clinical practitioner.
4 requirements
4.1 Mechanical properties
4.1.1 Functional elasticity
4.1.1.1 Functional spring force nominal tolerance
The manufacturer shall give the nominal value of the functional elastic force of the tension ring, which is the radial deformation of the tension ring at the symmetrical position of the tension ring to the prescribed diameter.
Radial deformation force. The nominal value of the functional elastic force is ±10%.
4.1.1.2 Functional elastic attenuation
The manufacturer shall give the yield characteristics of the tension ring after 24 hours of clinical application in the functional deformation to the prescribed diameter. The yield
The characteristic can be expressed in the form of a functional elastic attenuation ratio or a deformation ratio of the maximum peripheral size after compression release.
4.1.2 Shape variables and stresses
4.1.2.1 Elastic limit
The material of the tension ring should be uniform and the processing should be free of defects. When the tension ring is subjected to the following deformation test, there should be no abnormal changes due to stress concentration.
Shaped parts, and meet the following requirements at room temperature.
a) Apply radial force to the tension ring in a symmetrical position, release it immediately after compressing the deformation variable by 50%, and check the change of the maximum peripheral size.
Should not exceed 1% of the original value;
b) Apply force to both ends of the tension ring along the outer circumferential direction. When the torsion angle reaches 30°, release it immediately. Check the shape after recovery. The ring plane should be flat.
Whole, no residual deformation.
4.1.2.2 Yield limit
The tension ring should have a certain strength limit and should not break under the following conditions.
a) when the shape deformation direction is 70%;
b) Both ends of the outer circumference are twisted by a twist angle of 60° in the axial direction of the outer circumference.
4.1.3 Uniformity
The tension ring should have a uniform elastic force around the circumference under the circular compression. In order to meet this requirement, its shape should meet the following requirements.
a) The shape of the tension ring should be consistent with the shape characteristics given by the manufacturer's design;
b) The maximum dimension of the section on the symmetrical circular section (except the operating head end) shall be the same, and the deviation shall not exceed 20%.
4.1.4 Dynamic fatigue durability
The tension ring should be able to withstand the wave compression of the radial approximate sinusoidal deformation, the wave frequency is 1Hz~10Hz, and the compression range is 0.5mm.
250,000 cycles of dynamic fatigue test without breaking.
4.2 Size
The manufacturer shall at least give the key dimensions characterizing the shape of the tension ring, such as the maximum outer perimeter dimension, the largest cross-sectional dimension, the locating hole diameter, and the like.
See Table 1.
Table 1 Dimensional tolerance unit is mm
Project name tolerance
Maximum peripheral size ± 0.20
Maximum cross section size ± 0.02
Positioning hole diameter ± 0.02
4.3 Surface quality
The surface of the tension ring should be smooth and continuous in transition, and there is no defect that may cause damage to human tissue.
4.4 Extraction
The tension ring was tested by 0.9% NaCl inorganic solvent extraction, and the extraction rate should be less than 0.5%.
4.5 Biocompatibility
4.5.1 General
The tension ring material shall be made of materials that have been proven to be biocompatible, otherwise it shall be verified by the test of 4.5.2~4.5.5.
4.5.2 Cytotoxicity
The tension ring product should be cytotoxic.
4.5.3 Eye irritation
The finished tension ring should have no eye irritation.
4.5.4 delayed type hypersensitivity reaction
The tension ring product should have no delayed hypersensitivity reaction.
4.5.5 Intraocular implantation test
If the manufacturer cannot provide documentation of the safety of the material in the intraocular environment of the tension ring, an intraocular implant test should be performed to evaluate the implant.
The compatibility of the test material with the intraocular tissue.
4.6 Sterile
The tension ring shall remain sterile during the expiration date indicated on the label.
4.7 Ethylene oxide residue
If ethylene oxide is used for sterilization, the residual amount of ethylene oxide should be no more than 10 mg/kg.
4.8 Validity period
The performance of the tension ring during its validity period should meet the requirements.
5 Test methods
5.1 Mechanical performance check
5.1.1 Functional elastic test
5.1.1.1 Functional elastic value tolerance
Instrument. The minimum reading of the micro force meter is mN.
Step. Extract 3 tension rings and place the sample on the fixture of the micro force measuring instrument. The fixture can use Appendix A of YY 0290.3-2008.
s installation. Adjust the sample to make the outer ring force point symmetrical. The jig was then immersed in a physiological saline solution at 35 °C. Tested in a state where the tension ring is not deformed
The force meter reading should be cleared. Adjust the displacement device to make the tension ring reach the required displacement, read the value on the force gauge, repeat the measurement 3 times, take the arithmetic
Mean.
5.1.1.2 Functional elastic attenuation
Three tension rings were selected and tested using the method in Appendix F of YY 0290.3-2008.
a) The functional elastic attenuation ratio can be calculated on the basis of 5.1.1.1, and the ratio of the functional elastic attenuation to the functional elastic force is calculated.
b) The deformation ratio of the maximum outer circumference size, measure the maximum outer circumference size of the tension ring, calculate the deformation amount of the attenuated size and the maximum outer circumference
Inch ratio.
5.1.2 Shape variables and stress measurements
5.1.2.1 Flexibility limit
Instrument. Measurements are made using a projector.
Environment. 23 ° C ± 5 ° C.
step.
a) Extract 3 tension rings, measure and record the total diameter, compress the sample as required, and release it immediately after compressing the deformation variable 50%.
The maximum peripheral size is measured and recorded, and the results are compared before and after. The results should meet the requirements of 4.1.2.1 a).
b) Extract 3 tension rings, press the end of the tension ring with the clamping device, and apply the force to the other end along the outer circumference to make it twist up.
Released after l2 (opening distance l2=l1sin30°, where l1 is the shortest outer diameter), see Figure 2. Check the shape of the tension ring after recovery.
Description.
1---fixture;
2---tension ring;
L1---the shortest outer diameter;
L2---twisting distance;
θ---torsion angle.
Figure 2 Schematic diagram of axial torsion measurement of tension ring
5.1.2.2 Yield limit
The yield limit is tested as follows.
a) Extract 3 tension rings and compress the sample as required. When the compression deformation is 70%, the tension ring should meet the requirements of 4.1.2.2a).
b) Extract 3 tension rings, press the end of the tension ring with the clamping device, and apply the force to the other end along the outer circumference to make it twist up.
Released after l2 (opening distance l2=l1sin30°, where l1 is the shortest outer diameter), see Figure 2.
5.1.3 Uniformity check
Instrument. Projector.
Step. Extract 10 tension rings, and select 5 points on each sample for measurement.
5.1.4 Dynamic fatigue durability test
Three tension rings were selected and tested in physiological saline solution according to the principle of Appendix G equipment of YY 0290.3-2008.
5.2 Dimensional measurement
Measured with a measuring instrument.
5.3 Surface quality inspection
Check with an optical microscope of 10× or more.
5.4 Extraction test
Follow the method of Appendix B of YY 0290.5-2008.
5.5 Biocompatibility test
5.5.1 Cytotoxicity test
The preparation of the test solution was carried out in accordance with the method in GB/T 16886.12 and tested according to the method specified in GB/T 16886.5.
5.5.2 Eye irritation test
The preparation of the test solution was carried out in accordance with the method of GB/T 16886.12 and tested according to the method specified in GB/T 16886.10.
5.5.3 delayed type hypersensitivity test
The preparation of the test solution was carried out in accordance with the method of GB/T 16886.12 and tested according to the method specified in GB/T 16886.10.
5.5.4 Intraocular implantation test
The suitability test was carried out in accordance with the method in Appendix G of YY 0290.5-2008.
5.6 Sterility test
In accordance with the "Pestal Inspection Act" of the Pharmacopoeia of the People's Republic of China.
5.7 Ethylene oxide residue
According to the method of GB/T 14233.1.
5.8 Package Integrity Check
Visual inspection and unpacking inspection.
5.9 Validity test
According to the method of YY 0290.6, 4.2, 4.3, 4.6 and 4.7 were tested at each test point.
6 signs and instructions for use
6.1 The outer packaging of the tension ring should have the following contents.
a) the name, logo or trade name of the manufacturer;
b) the manufacturer's residence;
c) product lot number or serial number;
d) the word "sterile";
e) the expiration date expressed in years and months (may be symbolized);
f) Outline drawing of the tension ring.
6.2 The instru...