YY 0762-2017 English PDF

YY 0762-2017: Ophthalmic Optical - Capsular Tension Ring
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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
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 soluti...