YY 0762-2017_English: PDF (YY0762-2017)
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Ophthalmic optical -- Capsular tension ring
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YY 0762-2017
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| YY 0762-2009 | English | 120 |
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| Standard ID | YY 0762-2017 (YY0762-2017) | | Description (Translated English) | Ophthalmic optical--Capsular tension ring | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 9,980 | | Date of Issue | 2017-07-17 | | Date of Implementation | 2018-07-01 | | Older Standard (superseded by this standard) | YY 0762-2009 | | Drafting Organization | Zhejiang Medical Devices Testing Institute | | Administrative Organization | National Medical Optical Instrument Standardization Technical Committee (SAC/TC 103/SC 1) | | Regulation (derived from) | China Food & Drug Administration Announcement 2017 No. 84 | | Proposing organization | China Food and Drug Administration | | Issuing agency(ies) | State Food and Drug Administration | | Standard ID | YY 0762-2009 (YY0762-2009) | | Description (Translated English) | Ophthalmic optics - Capsular tension ring | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 9,943 | | Date of Issue | 2009-12-30 | | Date of Implementation | 2011-06-01 | | Quoted Standard | GB/T 191; GB 9969.1; GB/T 16886.1; GB/T 16886.5; GB/T 16886.6; GB/T 16886.7; GB/T 16886.10; YY 0290.3-2008; YY 0290.5-2008; YY 0290.6-2009; China People Republic Pharmacopoeia (2010) two | | Drafting Organization | Hangzhou, the State Food and Drug Administration Medical Device Quality Supervision and Inspection Center | | Administrative Organization | National Standardization Technical Committee of Medical optics and instruments | | Summary | This standard specifies the capsular tension ring scope, requirements, test methods, marking and instructions, packaging, transportation and storage. This standard applies to single-use capsular tension ring (hereinafter referred to as tension ring). Tension ring for aphakia maintain capsular tension and prevent posterior capsular folds, against the capsular bag shrinkage. |
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 0762-2009
ICS 11.040.70
C 40
Pharmaceutical Industry Standard
of the People’s Republic of China
Ophthalmic optics
Capsular tension ring
眼科光学囊袋张力环
Issued on December 30, 2009 Implemented on June 1, 2011
Issued by. State 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 Testing Methods... 9
6 Signs and Instructions for Use ... 11
7 Packaging, Transportation and Storage ... 12
References and Original Chinese Documents ... 13
Foreword
The performance requirements of this Standard are developed by basing on the
product clinical requirements and referring to the YY 0290 series of standards.
Biocompatibility requirements of this Standard shall be determined by referring to
GB/T16886.1 Evaluation of Medical Devices Biology Part 1. Guide of Select Test.
This Standard is approved by the State Food and Drug Administration.
This Standard is proposed and administered by National Medical Optical Instrument
Standardization Technical Committee (SAC/TC 103/SC1).
This Standard is drafted by organizations. Hangzhou Medical Device Quality
Supervision and Inspection Center of State Food and Drug Administration.
This Standard is mainly drafted by. Wen Yan, Jia Hang, and Feng Qin.
Ophthalmic optics -- Capsular tension ring
1 Scope
This Standard specifies the scope, requirements, test methods, marking and
instructions, packaging, transportation and storage of capsular tension ring.
This Standard applies to one-time use of capsular tension ring (hereinafter referred
to as “the tension ring”). Tension ring is for aphakia to maintain capsular tension, and
prevents posterior capsular from wrinkle, and is also used against the capsular bag
from contraction.
2 Normative references
The following normative documents contain provisions which, through reference in the
text, constitute provisions of this Standard. For dated reference, subsequent
amendments to, or revisions of, any of these publications (excluding contents of
corrigenda) do not apply. However, parties who enter into agreements based on this
Standard are encouraged to investigate the possibility of applying the most recent
editions of the Standards indicated below. For undated references, the latest edition
of the normative document referred to applies.
GB/T 191 Packaging-Pictorial marking for handling of goods
GB 9969.1 Instructions of industrial products – General Principles
GB/T 16886.1 Evaluation of Medical Devices Biology Part 1. Evaluation and Testing
(ISO 10993.1.1997, IDT)
GB/T 16886.5 Evaluation of Medical Devices Biology Part 5. The Test of Vitro
Cytotoxicity (ISO 10993.5.1999, IDT)
GB/T 16886.6 Evaluation of Medical Devices Biology Part 6. The Test of Local
Reactions after Implanting (ISO 10993.6.1994, IDT)
GB/T 16886.7 Evaluation of Medical Devices Biology Part 6. The Amount of Ethylene
Oxide Sterilization Residuals (ISO 10993.7.1995 IDT)
5 Testing Methods
5.1 Test of Mechanical Properties
5.1.1 Functional Stretch Test
5.1.1.1 Tolerance of Nominal Value of Functional Stretch
Instrument. Minimal reading of micro-force meter is. mN.
Steps. SAMPLE 3 tension rings. PLACE the samples on the fixture of the micro-force
meter. The fixture may use the device of Appendix A of YY 0290.3. ADJUST the
samples to make the outer force-point to be symmetric. Then IMMERSE the fixture in
the 35ºC physiological salt solution. Under the state of the tension ring is not
deformed, the meter’s reading shall be reset to zero. ADJUST the shifter to make the
tension ring meet the requirements of position-shift. READ the value on the meter.
REPEAT the tests 3 times and GET the arithmetic mean.
5.1.1.2 Functional Stretch Attenuation
a) The ratio test of functional stretch attenuation shall be conducted and based on
5.1.1.1.1. CALCULATE the functional stretch attenuation and the ratio of functional
stretch.
b) The ratio test of the deformation of the total diameter. SELECT 3 tension rings,
MEASURE total diameter of the respective tension rings and RECORD the
corresponding measuring points. PLACE the tension rings inside the device of
Appendix F of YY 0290.3 and IMMERSE them in container with salt solution. Then
IMMERSE the container into the 35ºC water bath and MAINTAIN for 24h. REMOVE
them carefully and immediately MEASURE the total diameter of tension rings.
CALCULATE the ratio of deformation and compression.
5.1.2 Deformation and Stress Measurement
Instrument. USE projector to measure
Environment. 23ºC to 5ºC.
Steps.
a) SAMPLE 3 tension rings, MEASURE and RECORD the total diameter.
COMPRESS samples as required and MAINTAIN for 3 minutes. After Restoring for
5.5.3 Test of Delayed-type Hypersensitivity
CONDUCT the test according to the methods in GB/T 16886.10. The results shall be
consistent with the regulations in 4.5.3.
5.5.4 Test of Ocular and Non-Ocular Implantation
CONDUCT the test according to the methods in GB/T 16886.6. The results shall be
consistent with the regulations in 4.5.4.
5.6 Test of Sterilization
5.6.1 Test of sterilization shall be conducted according to the methods in GB/T
14233.2. The results shall be consistent with the regulations in 4.6.1.
5.6.2 The test of residual ethylene oxide shall be conducted according to the methods
in GB/T 14233.1. The results shall be consistent with the regulations in 4.6.2.
5.7 Test of Packaging Integrity
Inspected with eyes and unpacking inspection - The results shall be consistent with
the regulations in 4.7.
5.8 Test of Validity
CONDUCT the test according to the methods in YY 0290.6. TEST each testing point
according to 4.2, 4.3, 4.6 and 4.7. The results shall be consistent with the
requirements in 4.8.
6 Signs and Instructions for Use
6.1 The storage container of tension ring shall have the following contents.
a) Name of manufacturer, logo or trade name;
b) Manufacturer’s address;
c) Product name of tension ring (including possible product number);
d) Product lot number or production date;
e) Words of "Sterilization";
f) Expiration date – expressed in year and month (symbol expression may be used);
g) The appearance drawing of tension ring.
6.2 Instructions for use shall be consistent with the regulations in GB 9969.1-1998
References and Original Chinese Documents
[1] YY 0762-2009 Ophthalmic optics Capsular tension ring.
......
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