YY/T 0290.6-2021 English PDFUS$299.00 · In stock
Delivery: <= 3 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0290.6-2021: (Ophthalmic optics intraocular lens - Part 6: Shelf life and transportation stability) Status: Valid YY/T 0290.6: Historical versions
Basic dataStandard ID: YY/T 0290.6-2021 (YY/T0290.6-2021)Description (Translated English): (Ophthalmic optics intraocular lens - Part 6: Shelf life and transportation stability) Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C40 Word Count Estimation: 15,130 Issuing agency(ies): State Drug Administration YY/T 0290.6-2021: (Ophthalmic optics intraocular lens - Part 6: Shelf life and transportation stability)---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 lens part 6.shelf life and transportation stability) ICS 11.040 C40 People's Republic of China Pharmaceutical Industry Standard Replacing YY/T 0290.6-2009 Ophthalmic optical intraocular lens Part 6.Shelf life and shipping stability (ISO 11979-6.2014, Ophthalmicimplants-Intraocularlenses- 2021-09-06 Released 2022-09-01 Implementation Released by the State Drug Administration directory Preface III Introduction V 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Requirement 1 5 Test Methods and Sampling 5 Appendix A (Informative Appendix) Validity Test Example 6 Appendix B (Informative Appendix) Test Items Required for Validity Test 9 Reference 10 forewordYY/T 0290 "Ophthalmic Optical Intraocular Lens" is divided into 9 parts. --- Part 1.Terminology; --- Part 2.Optical properties and their test methods; --- Part 3.Mechanical properties and their test methods; --- Part 4.Labels and information; --- Part 5.Biocompatibility; --- Part 6.Validity period and transport stability; --- Part 8.Basic requirements; --- Part 9.Multifocal intraocular lenses; --- Part 10.Phakic intraocular lenses. This part is Part 6 of YY/T 0290. This section is drafted in accordance with the rules given in GB/T 1.1-2009. This Part replaces YY/T 0290.6-2009 "Ophthalmic Optical Intraocular Lens Part 6.Validity Period and Transportation Stability", and Compared with YY/T 0290.6-2009, the main technical changes other than editorial changes are as follows. --- Modified the "normative references" (see Chapter 2, Chapter 2 of the.2009 edition); --- Revised "General Requirements" (see 4.1, 4.1 of the.2009 edition); --- Modified the "test parameters" (see 4.3.2.1, 4.3.2.1 of the.2009 edition); --- Added "pre-installed system" (see 4.3.2.2); --- Modified the "test procedure" (see 4.3.2.3, 4.3.2.3 of the.2009 edition); --- Modified the "accelerated validity test" (see 4.3.3, 4.3.3 of the.2009 edition); --- Modified "Packaging Integrity" (see 4.4, 4.4 of the.2009 edition); --- Modified the requirements for transportation stability test (see 4.5, 4.5 of the.2009 edition); --- Modified the "Conclusion" (see 4.6, 4.6 of the.2009 edition); --- Modified "Appendix A" (see Appendix A, Appendix A of the.2009 edition). This part uses the redrafted method to modify and adopt ISO 11979-6.2014 "Ophthalmic Implants and Intraocular Lenses - Part 6.Validity Period" and transport stability". There are technical differences between this part and ISO 11979-6.2014, and the clauses involved in these differences have been specified in the outer margins The vertical single line (|) of the position is marked. The technical differences between this part and ISO 11979-6.2014 and the reasons are as follows. --- Regarding normative reference documents, this part has made adjustments with technical differences to adapt to the technical conditions of our country and the circumstances of the adjustment. The situation is reflected in Chapter 2 "Normative References", and the specific adjustments are as follows. ● Replace ISO 10993-5 with GB/T 16886.5 which is equivalent to adopting international standards; ● Replace ISO 10993-12 with GB/T 16886.12 which is equivalent to adopting international standards; ● Replace ISO 11607-1 with GB/T 19633.1 which is equivalent to adopting international standards; ● Replace ISO 11607-2 with GB/T 19633.2 which is equivalent to adopting international standards; ● Replace ISO 14971 with YY/T 0316 which is equivalent to adopting international standards; ● Replace ISO 11979-1 with YY/T 0290.1 which is equivalent to adopting international standards; ● Added reference to YY/T 0942; --- Modified the content of the cytotoxicity test [see 4.3.2.1k)] to suit my country's national conditions; --- Modified the chemical reaction requirements between the pre-installed system and the intraocular lens material, in the form of a note (see 4.3.2.2), with Suitable for my country's national conditions; --- Modified the actual storage conditions [see 4.3.2.3c)] to suit my country's national conditions. The following editorial changes have been made to this section. --- Modified the standard name; --- Add a note in the content of the general requirements (see 4.3.1); --- Increase the number of samples in A.3 in Appendix A and the number of samples at zero time point in Table A.1; --- Revised references. Please note that some content of this document may be patented. The issuing authority of this document assumes no responsibility for identifying these patents. This part is proposed by the State Drug Administration. This part is regulated by the National Optical and Photonics Standardization Technical Committee Medical Optics and Instruments Sub-Technical Committee (SAC/TC103/ SC1) focal point. This section is drafted by. Zhejiang Medical Device Inspection and Research Institute, Alcon (China) Ophthalmic Products Co., Ltd., Aibo Nord (Beijing) Medical Technology Co., Ltd. The main drafters of this section. Feng Qin, Song Ting, Yang Zhifang, Wang Shaohua, Zhang Li, Hu Jiefeng, Luo Yongjie, Lu Jiajun. The previous versions of the standards replaced by this part are as follows. ---YY 0290.6-1997, YY/T 0290.6-2009.IntroductionThe purpose of a stability study is to determine, under the influence of a specified set of environmental conditions, over a sufficiently long period of time, how well an intraocular lens is Can still maintain the original characteristics. In general for new intraocular lens materials, new compounds for intraocular lens materials, new packaging materials or new manufacturing processes In the investigation and research, the storage stability of intraocular lens material is an important factor. aging the lens in the storage container Experimental studies can be used to evaluate the storage stability of intraocular lenses. Changes in material composition, material suppliers, manufacturing environment (including sterilization process), packaging design, or materials can all affect intraocular lenses The length of the expiry date, which requires a new test of the intraocular lens to determine its expiry date. product stability, packaging integrity and shipping The necessity of the study of infusion stability can be assessed according to YY/T 0316. The design of stability experiments should be based on known IOL material properties and recommendations for IOL use. storage or acceleration The amount and identity of the extracted material obtained after aging tests are important for evaluating new intraocular lens materials. According to the information obtained, the corresponding transportation and storage conditions can be recommended, so as to ensure the safety, validity and acceptability. The results obtained are also suitable for determining the expiry date of intraocular lenses. Since the stability test is an experiment conducted on the material and integrity of the intraocular lens. Therefore, the stability of the intraocular lens What is studied is the characteristics of the material. Under the condition that the intraocular lens material, packaging material and production process remain unchanged, one type of intraocular lens can be treated. Experiments are carried out on the body, and the verification results should be representative. Ophthalmic optical intraocular lens Part 6.Shelf life and shipping stability1 ScopeThis part of YY/T 0290 specifies the tests to determine the validity period of sterile intraocular lenses (IOLs) in complete packages. Procedures for establishing the stability of intraocular lenses during distribution and storage are included.2 Normative referencesThe following documents are essential for the application of this section. For dated references, only the dated version applies to this article pieces. For undated references, the latest edition (including all amendments) applies to this section. GB/T 16886.5 Biological Evaluation of Medical Devices Part 5.In Vitro Cytotoxicity Test (GB/T 16886.5-2017, ISO 10993-5.2009, IDT) GB/T 16886.12 Biological Evaluation of Medical Devices Part 12.Sample Preparation and Reference Materials (GB/T 16886.12- 2017, ISO 10993-12.2012, IDT) GB/T 19633.1 Terminally sterilized medical device packaging - Part 1.Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633.1-2015, ISO 11607-1.2006, IDT) GB/T 19633.2 Terminally sterilized medical device packaging - Part 2.Requirements for validation of forming, sealing and assembly processes (GB/T 19633.2-2015, ISO 11607-1.2006, IDT) YY/T 0290.1 Ophthalmic Optical Intraocular Lens Part 1.Terminology (YY/T 0290.1-2008, ISO 11979-1. 2006, MOD) YY/T 0316 Application of Medical Device Risk Management to Medical Devices (YY/T 0316-2016, ISO 14971.2007 Correction version, IDT) YY/T 0942 Ophthalmic Optical Intraocular Lens Implantation System3 Terms and DefinitionsTerms and definitions defined in YY/T 0290.1 apply to this document.4 Requirements4.1 General requirements According to the risk analysis of YY/T 0316, if it is found necessary to conduct product stability test, packaging integrity test and/or transport stability test Qualitative tests should be planned and directed according to this section. The research protocol should be given before the test. The test results shall demonstrate that the performance, safety and product acceptability measurement parameters of the product are maintained within the corresponding tolerances of the product specification Within the range, if the manufacturer cannot give the corresponding product specification, the measurement parameters should meet the corresponding YY/T 0290 tolerance requirements. if neither Corresponding product specifications can be given, and it cannot be based on the corresponding YY/T 0290 standard requirements. The test results should be the same as the sample test at the zero time point. ...... |
