YY/T 0862-2023 English PDFUS$309.00 · In stock
Delivery: <= 4 days. True-PDF full-copy in English will be manually translated and delivered via email. YY/T 0862-2023: Ophthalmic Optics - Ocular endotamponades Status: Valid YY/T 0862: Historical versions
Basic dataStandard ID: YY/T 0862-2023 (YY/T0862-2023)Description (Translated English): Ophthalmic Optics - Ocular endotamponades Sector / Industry: Medical Device & Pharmaceutical Industry Standard (Recommended) Classification of Chinese Standard: C40 Classification of International Standard: 11.040.70 Word Count Estimation: 16,126 Date of Issue: 2023-03-14 Date of Implementation: 2024-05-01 Older Standard (superseded by this standard): YY/T 0862-2011 Issuing agency(ies): State Drug Administration Summary: This standard specifies general requirements for the expected performance, design properties, design evaluation, sterilization, product stability, delivery system integrity and performance, packaging, and information provided by the manufacturer of intraocular fillers. This document applies to intraocular fillers. YY/T 0862-2023: Ophthalmic Optics - Ocular endotamponades---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.ICS11:040:70 CCSC40 Pharmaceutical Industry Standard of the People's Republic of China Replace YY/T 0862-2011 Ophthalmic Optical Eye Fillers Ophthalmic Optics - Ocular endotamponades Released on 2023-03-14 2024-05-01 Implementation Released by the State Drug Administration table of contentsPreface I 1 Scope 1 2 Normative references 1 3 Terms and Definitions 1 4 Expected performance 2 5 Design attributes 3 6 Design Evaluation 5 7 Sterilization6 8 Product Stability6 9 Conveyor System Integrity and Performance 6 10 packs of 6 11 Information provided by the manufacturer 7 Appendix A (informative) Method for quantifying incompletely fluorinated pollutants in perfluorocarbon liquids9 Appendix B (Normative) Eye Implantation Test 10 Reference 11forewordThis document is in accordance with the provisions of GB/T 1:1-2020 "Guidelines for Standardization Work Part 1: Structure and Drafting Rules for Standardization Documents" to be drafted: This document replaces YY/T 0862-2011 "Ophthalmic Implants Intraocular Fillers": Compared with YY/T 0862-2011, except for structural In addition to rectification and editorial changes, the main technical changes are as follows: --- Changed the terms and definitions of "shear viscosity" (see 3:2, 3:2 of the:2011 edition); --- Deleted the terms and definitions of "non-solid substances" (see 3:5 of the:2011 edition); --- Added the term and definition of "intraocular filler" (see 3:5); --- Changed the terms and definitions of "primary packaging" (see 3:6, 3:8 of the:2011 edition); --- Added the terms and definitions of "secondary packaging" (see 3:9); --- Added the term and definition of "surgical implant" (see 3:11); --- Changed the terms and definitions of "vapor pressure" (see 3:12, 3:7 of the:2011 edition); --- Added the terms and definitions of "minimum operating pressure" (see 3:13); --- Changed the "expected performance" (see Chapter 4, Chapter 4 of the:2011 edition); ---Changed the "chemical description and impurities/pollutants" (see 5:2, 5:2, 5:3, 5:4 of the:2011 edition); --- Changed the "kinematic viscosity" (see 5:6, 5:8 of the:2011 edition); --- Added "shear viscosity" (see 5:7); --- Changed "particles" (see 5:9, 5:10 of the:2011 edition); --- Changed the "refractive index" (see 5:10, 5:11 of the:2011 edition); --- Changed the "vapor pressure" (see 5:13, 5:14 of the:2011 edition); --- Added "visible foreign matter" (see 5:14); --- Added "loading capacity" (see 5:15); ---Changed the "bacterial endotoxin test" (see 6:2:2, 6:2:2 of the:2011 edition); --- Changed "ethylene oxide" (see 6:2:4, 6:2:4 of the:2011 edition); ---Changed "clinical research" (see 6:3, 6:3 of the:2011 edition); --- Changed the "information provided by the manufacturer" (see Chapter 11, Chapter 11 of the:2011 edition): This document is modified to adopt ISO 16672:2020 "Ophthalmic Optics Intraocular Fillings": The technical differences between this document and ISO 16672:2020 and their reasons are as follows: --- Regarding the normative reference documents, this document has made adjustments with technical differences to adapt to the technical conditions of our country: The whole is: ● Replaced ISO 10993-1 with GB/T 16886:1, which is equivalent to the international standard; ● Replaced ISO 10993-2 with GB/T 16886:2, which is equivalent to the international standard; ● Replaced ISO 10993-6 with GB/T 16886:6, which is equivalent to the international standard; ● Replaced ISO 11607-1 with GB/T 19633:1, which is equivalent to the international standard; ● Replaced ISO 13408-1 with YY/T 0567:1, which is equivalent to the international standard; ● Replaced ISO 14630 with YY/T 0640, which is equivalent to the international standard; ● Replaced ISO 14971 with GB/T 42062, which is equivalent to the international standard; ● Replaced ISO 15223-1 with YY/T 0466:1, which is equivalent to the international standard; ● Deleted ISO 14155, EN1041 A1; ● Added four volumes of Pharmacopoeia of the People's Republic of China; ---Changed 5:3 "density" and added the density unit "grams per cubic centimeter (g/cm3)"; ---Changed 5:9 "Particles", added the particle type and limit value of the product, clarified the specific performance indicators of the product, and improved the operability active; ---Changed 5:13 "Vapor Pressure" and added the vapor pressure unit "kilopascal (kPa)"; --- Added 5:14 "Visible foreign matter", added the requirement that the product should be free of visible foreign matter, added product performance indicators, and ensured the safety of the product all valid; --- Added 5:15 "loading capacity", increased the requirements for the minimum and average loading capacity of the product, supplemented product performance indicators, and ensured the product's Safe and effective; ---Changed 6:1 "General Provisions"; ---Changed 6:2:3 "eye implant test"; ---Changed 6:3 "Clinical research" and deleted some content of clinical research; ---Chapter 7 "Sterilization" was changed, and the recommended sterilization method standard was deleted, which was cited in YY/T 0640; ---Changed Chapter 11 "Information provided by the manufacturer", corrected the wrong expression related to Table 1 in ISO 16672:2020, and changed the "storage "Storage packaging" is changed to "secondary packaging": The following editorial changes have been made to this document: --- Changed the standard name and scope; --- Deleted "Appendix B"; ---Changed references: Please note that some contents of this document may refer to patents: The issuing agency of this document assumes no responsibility for identifying patents: This document is proposed by the State Drug Administration: This document is under the jurisdiction of the National Medical Optics and Instruments Standardization Sub-Technical Committee (SAC/TC103/SC1): This document is drafted by: Zhejiang Institute of Medical Device Inspection and Research, Shanghai Jieshi Medical Technology Co:, Ltd: The main drafters of this document: Chen Xianhua, Fang Li, Zhang Li, Zhao Jinchuan, Lin Xinyi, Han Yin, Hu Meili, Xia Zhongcheng, Chen Yuhui: The previous versions of the standards replaced by this document are as follows: ---First published as YY/T 0862-2011 in:2011; --- This is the first revision: Ophthalmic Optical Eye Fillers1 ScopeThis document specifies the expected performance, design attributes, design evaluation, sterilization, product stability, integrity of delivery system, etc: of intraocular fillers: General requirements such as integrity and performance, packaging, information provided by the manufacturer, etc: This document applies to intraocular fillers:2 Normative referencesThe contents of the following documents constitute the essential provisions of this document through normative references in the text: Among them, dated references For documents, only the version corresponding to the date is applicable to this document; for undated reference documents, the latest version (including all amendments) is applicable to this document: GB/T 16886:1 Biological evaluation of medical devices Part 1: Evaluation and testing in the risk management process (GB/T 16886: 1-2022, ISO 10993-1:2018, IDT) GB/T 16886:2 Biological evaluation of medical devices Part 2: Animal welfare requirements (GB/T 16886:2-2011, ISO 10993-2:2006, IDT) GB/T 16886:6 Biological evaluation of medical devices Part 6: Local reaction test after implantation (GB/T 16886:6- 2022, ISO 10993-6:2016, IDT) GB/T 19633:1 Packaging for terminally sterilized medical devices - Part 1: Requirements for materials, sterile barrier systems and packaging systems (GB/T 19633:1-2015, ISO 11607-1:2006, IDT) Application of GB/T 42062 Medical Device Risk Management to Medical Devices (GB/T 42062-2022, ISO 14971: 2019, IDT) YY/T 0466:1 Symbols for Medical Device Labeling, Marking and Information Provision for Medical Devices Part 1: General Requirements (YY/T 0466:1-2016, ISO 15223-1:2012, IDT) YY/T 0567:1 Aseptic processing of healthcare products Part 1: General requirements (YY/T 0567:1-2013, ISO 13408-1:2008, IDT) YY/T 0640 General requirements for passive surgical implants (YY/T 0640-2016, ISO 14630:2012, IDT) Pharmacopoeia of the People's Republic of China Volume Four3 Terms and DefinitionsThe following terms and definitions apply to this document: 3:1 Conveyor systemdeliverysystem Sealed container with product and add-on kit for infusing the product into the eye: 3:2 Shear viscosity dynamicviscosity The quotient of shear stress and shear rate: Note: Shear viscosity can be expressed in Pascal seconds (Pa·s): ......Tips & Frequently Asked Questions:Question 1: How long will the true-PDF of YY/T 0862-2023_English be delivered?Answer: Upon your order, we will start to translate YY/T 0862-2023_English as soon as possible, and keep you informed of the progress. 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Otherwise, follow the normal steps: Add to Cart -- Checkout -- Select your currency to pay.Question 5: Should I purchase the latest version YY/T 0862-2023?Answer: Yes. Unless special scenarios such as technical constraints or academic study, you should always prioritize to purchase the latest version YY/T 0862-2023 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. |
