YY 0290.3-2018 English PDFUS$559.00 · In stock
Delivery: <= 5 days. True-PDF full-copy in English will be manually translated and delivered via email. YY 0290.3-2018: Ophthalmic optics. Intraocular lenses - Part 3: Mechanical properties and test methods Status: Valid YY 0290.3: Historical versions
Basic dataStandard ID: 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11.040 Word Count Estimation: 28,247 Date of Issue: 2018-12-20 Date of Implementation: 2020-06-01 Older Standard (superseded by this standard): YY 0290.3-2008 Quoted Standard: YY 0290.1; YY 0290.2 Adopted Standard: ISO 11979-3-2012, MOD Regulation (derived from): State Drug Administration Announcement No. 97 of 2018 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---This is a DRAFT version for illustration, not a final translation. Full copy of true-PDF in English version (including equations, symbols, images, flow-chart, tables, and figures etc.) will be manually/carefully translated upon your order. (Ophthalmic optics - Intraocular lenses - Part 3. Mechanical properties and test methods) ICS 11.040 C40 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 ContentForeword III Introduction IV 1 Scope 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 24ForewordThe 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.IntroductionThis 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 methods1 ScopeThis 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 referencesThe 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 definitionsThe terms and definitions defined in YY 0290.1 apply to this document.4 requirements4.1 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. ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY 0290.3-2018_English be delivered?Answer: Upon your order, we will start to translate YY 0290.3-2018_English as soon as possible, and keep you informed of the progress. The lead time is typically 3 ~ 5 working days. The lengthier the document the longer the lead time.Question 2: Can I share the purchased PDF of YY 0290.3-2018_English with my colleagues?Answer: Yes. The purchased PDF of YY 0290.3-2018_English will be deemed to be sold to your employer/organization who actually pays for it, including your colleagues and your employer's intranet.Question 3: Does the price include tax/VAT?Answer: Yes. Our tax invoice, downloaded/delivered in 9 seconds, includes all tax/VAT and complies with 100+ countries' tax regulations (tax exempted in 100+ countries) -- See Avoidance of Double Taxation Agreements (DTAs): List of DTAs signed between Singapore and 100+ countriesQuestion 4: Do you accept my currency other than USD?Answer: Yes. If you need your currency to be printed on the invoice, please write an email to Sales@ChineseStandard.net. In 2 working-hours, we will create a special link for you to pay in any currencies. Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY 0290.3-2018?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY 0290.3-2018 even if the enforcement date is in future. Complying with the latest version means that, by default, it also complies with all the earlier versions, technically. |
