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YY 0290.3-2018

Chinese Standard: 'YY 0290.3-2018'
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YY 0290.3-2018English499 Add to Cart Days<=5 Ophthalmic optics. Intraocular lenses - Part 3: Mechanical properties and test methods Valid YY 0290.3-2018
YY 0290.3-2018Chinese28 Add to Cart <=1-day [PDF from Chinese Authority, or Standard Committee, or Publishing House]  

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Detail Information of YY 0290.3-2018; YY0290.3-2018
Description (Translated English): Ophthalmic optics. Intraocular lenses - Part 3: Mechanical properties and test methods
Sector / Industry: Medical Device & Pharmaceutical Industry Standard
Classification of Chinese Standard: C40
Classification of International Standard: 11.040
Word Count Estimation: 28,248
Date of Issue: 2018-12-20
Date of Implementation: 2020-06-01
Older Standard (superseded by this standard): YY 0290.3-2008
Quoted Standard: YY 0290.1; YY 0290.2
Adopted Standard: ISO 11979-3-2012, MOD
Drafting Organization: Zhejiang Medical Device Inspection Institute
Administrative Organization: National Medical Optical and Instrument Standardization Subcommittee
Regulation (derived from): State Drug Administration Announcement No. 97 of 2018
Proposing organization: State Drug Administration
Issuing agency(ies): State Drug Administration
Summary: This standard specifies the main mechanical performance requirements and test methods for intraocular lenses. This standard applies to the intraocular lens implanted in the anterior segment of the human eye. This standard does not apply to corneal implants.

YY 0290.3-2018
(Ophthalmic optics - Intraocular lenses - Part 3. Mechanical properties and test methods)
ICS 11.040
People's Republic of China Pharmaceutical Industry Standard
Replacing YY 0290.3-2008
Ophthalmic optical intraocular lens
Part 3. Mechanical properties and test methods
Part 3. Mechanicalpropertiesandtestmethods
(ISO 11979-3.2012, MOD)
Published on.2018-12-20
2020-06-01 implementation
State Drug Administration issued
Foreword III
Introduction IV
1 range 1
2 Normative references 1
3 Terms and Definitions 1
4 Requirements 1
4.1 Overview 1
4.2 Size and tolerance 2
4.3 Gap analysis (for anterior chamber intraocular lens) 2
4.4 Compression force 2
4.5 Axial displacement under compression 2
4.6 Optical eccentricity 2
4.7 Optical tilt angle 2
4.8 Contact angle 3
4.9 Compression force attenuation 3
4.10 Dynamic fatigue durability 3
4.11 Surgical operation 3
4.12 Surface and material uniformity 3
5 Performance recovery of simulated surgical operations 3
6 Additional requirements for adjustable intraocular lenses (AIOLs) 4
Appendix A (Normative Appendix) Compression Test 5
Appendix B (Normative) Test for axial displacement under compression 8
Appendix C (Normative) Optical eccentricity test 10
Appendix D (Normative) Optical Dip Test 12
Appendix E (Normative) Test of contact angles 15
Appendix F (Normative Appendix) Test for Compressive Force Attenuation 17
Appendix G (Normative) Test for Dynamic Fatigue Durability 18
Appendix H (informative) 襻 tensile strength test 20
Appendix I (informative) Gap Analysis 21
Appendix J (informative) Accuracy 24
The full technical content of this standard is mandatory.
YY 0290 "Ophthalmic Optical Intraocular Lens" is divided into 9 parts.
--- Part 1. Terminology;
--- Part 2. Optical properties and test methods;
--- Part 3. Mechanical properties and test methods;
--- Part 4. Labels and information;
---Part 5. Biocompatibility;
--- Part 6. Validity and transport stability;
--- Part 8. Basic requirements;
---Part 9. Multifocal intraocular lens;
--- Part 10. There is a phakic intraocular lens.
This part is the third part of YY 0290.
This part is drafted in accordance with the rules given in GB/T 1.1-2009.
This part replaces YY 0290.3-2008 "Ophthalmic optical intraocular lens Part 3. Mechanical properties and test methods", and
Compared with YY 0290.3-2008, the main differences are as follows.
--- Change the recommended terms to mandatory (see 4.9);
--- Increase the content of the introduction (see introduction);
--- Increase the requirements for the ring-shaped intraocular lens and the accommodating intraocular lens (see 4.1, Chapter 5, Chapter 6);
--- Modify the requirements of the gap analysis (see 4.3, 4.3 of the.2008 edition).
This section uses the drafting method to modify the use of ISO 11979-3.2012 "Ophthalmic Implants IOLs Part 3. Mechanical Properties and
Test Method (English version). There are technical differences between this part and ISO 11979-3.2012. The terms involved in these differences have been passed.
The vertical single line (|) at the outer margin of the outer side is marked.
---About the normative reference documents, this standard has made technical adjustments to adapt to China's technical conditions, adjustments
The situation is reflected in Chapter 2, “Regulatory Citations”, and the specific adjustments are as follows.
● Replace ISO 11979-1 with YY 0290.1;
● Replace ISO 11979-2 with YY 0290.2.
--- The introduction part deletes the relevant content of the ISO 11979-7 clinical investigation;
--- Remove from the scope "If the test method is also suitable for special intraocular lens design," content;
--- 4.1 Overview in the "for some designs and applications" after the addition of "YY 0290 requirements of this part, if not applicable, should give full rationale
By ", delete "in this case". Add "Note. Factory inspection can determine its sampling rules according to the manufacturer's specific circumstances. ”
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 part is proposed by the State Drug Administration.
This part is under the jurisdiction of the National Technical Committee for Standardization of Medical Optics and Instruments (SAC/TC103/SC1).
This section drafted by. Zhejiang Medical Device Inspection Institute.
The main drafters of this section. Feng Qin, Jia Xiaohang, Luo Yongjie, Chen Qionghui, Song Ting.
The previous versions of the standards replaced by this section are.
---YY 0290.3-1997;
---YY 0290.3-2008.
This part of YY 0290 contains test methods with relevant requirements and test methods that do not have explicit requirements. The former for people
The safety or performance of the working lens is necessary, while the latter provides basic information for the ophthalmologist or other intended users.
There are a variety of intraocular lens designs on the market, so in any case, it is suitable for all testers of intraocular lenses.
The law does not exist. It is expected that new materials currently being developed will lead to large-scale new designs, which may require revision or construction of the original method.
Establish other test methods. As with all standards, parties using standards can modify or improve the corresponding methods and provide relevant principles and tests.
Information and shall be consistent with this part of YY 0290.
In any case, given different tolerances are related to material or design, which reflects the current state of the product.
Ophthalmic optical intraocular lens
Part 3. Mechanical properties and test methods
1 Scope
This section of YY 0290 specifies the main mechanical properties and test methods for intraocular lenses.
This section applies to the intraocular lens implanted in the anterior segment of the human eye.
This section does not apply to corneal implants.
2 Normative references
The following documents are indispensable for the application of this document. For dated references, only the dated version applies to this article.
Pieces. For undated references, the latest edition (including all amendments) applies to this document.
YY 0290.1 Ophthalmic optical intraocular lens Part 1. Terminology (YY 0290.1-2008, ISO 11979-1.2006, MOD)
YY 0290.2 Ophthalmic optical intraocular lens Part 2. Optical performance and test methods (YY 0290.2-2009,
ISO 11979-2.1999, MOD)
3 Terms and definitions
The terms and definitions defined in YY 0290.1 apply to this document.
4 requirements
4.1 Overview
For all intraocular lenses, mechanical properties must be tested under simulated intraocular conditions. Record the use of the solution for each test
Precise composition. If the deviation of the test condition from the given simulated intraocular condition has been verified, such a change test condition can be used, such as.
Temperature conditions, a test environment should be given in the test report.
To complete each of the tests described below, at least 3 batches of medium power intraocular lenses should be tested if the power affects performance.
Test, the sample to be tested should consist of one batch of low, medium and high power. For ring-shaped intraocular lenses, each batch of these 3 batches
In the middle, half of the intraocular lens has the highest cylindrical lens and the other half of the intraocular lens has the lowest cylindrical lens. In general, each batch
The minimum number of samples should be 10, and each batch should represent the intraocular lens sold. The sampling rules used should be stated in each case.
The mean and standard deviation of the pooled samples should be given in the report.
For some designs and applications, the requirements in this section of YY 0290, if not applicable, should be justified. This part of YY 0290
If the specific test method described is not applicable, the manufacturer of the intraocular lens should give the corresponding test method and prove its validity and rationality.
The theoretical mechanism of action of the AIOL to change the power of the human eye should be described, such as artificial compression.
The curvature of the lens changes or the displacement of the lens element, and the like. The general principles that produce this mechanism of action should be described and specified. For theory
The maximum and minimum limits contained in the mechanism of action should be further tested mechanically, if the dynamic response of the mechanism of action is time dependent,
This time correlation should be described.
Note. The factory inspection can determine the sampling rules according to the manufacturer's specific conditions.
Related standard:   YY 0762-2017  YY/T 0619-2017
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