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YY 0861-2024: Ophthalmic optics - Ophthalmic Visco surgical devices
Status: Valid YY 0861: Evolution and historical versions
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Ophthalmic optics - Ophthalmic Visco surgical devices
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| YY 0861-2011 | English | 419 |
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Ophthalmic optics. Ophthalmic viscosurgical devices
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PDF similar to YY 0861-2024
Basic data | Standard ID | YY 0861-2024 (YY0861-2024) | | Description (Translated English) | Ophthalmic optics - Ophthalmic Visco surgical devices | | Sector / Industry | Medical Device & Pharmaceutical Industry Standard | | Classification of Chinese Standard | C40 | | Classification of International Standard | 11.040.70 | | Word Count Estimation | 22,262 | | Date of Issue | 2024-07-08 | | Date of Implementation | 2027-07-20 | | Older Standard (superseded by this standard) | YY 0861-2011 | | Issuing agency(ies) | State Drug Administration | YY 0861-2024: Ophthalmic optics - Ophthalmic Visco surgical devices---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.
ICS 11.040.70
CCSC40
Pharmaceutical Industry Standards of the People's Republic of China
Replaces YY 0861-2011
Ophthalmic Optical Viscoelastics
devices,MOD)
Released on 2024-07-08
2027-07-20 Implementation
The State Drug Administration issued
Table of Contents
Preface III
1 Scope 1
2 Normative references 1
3 Terms and Definitions 2
4 Expected Performance 3
5 Design attributes 3
5.1 General requirements 3
5.2 Ingredient characteristics 4
5.3 Finished product characteristics 4
5.4 Availability 6
6 Design Evaluation 6
6.1 General requirements 6
6.2 Biological safety assessment 6
7 Sterilization 7
8 Product Stability 8
9 Conveyor System Integrity and Performance 8
10 Packaging 8
10.1 Damage prevention during storage and transportation 8
10.2 Maintaining Sterility During Transport 8
11 Information provided by the manufacturer 8
Appendix A (Normative) Intraocular implantation test 10
Reference 13
Foreword
This 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"
Drafting.
This document replaces YY 0861-2011 "Ophthalmic Optical Viscoelastics". Compared with YY 0861-2011, in addition to structural adjustments and compilation
In addition to logical changes, the main technical changes are as follows.
--- Deleted the definition of "lost to follow-up cases" (see 3.5 of the.2011 edition);
--- Changed the definition of "primary packaging" (see 3.6, 3.7 of the.2011 edition);
--- Added the definition of "surgical implant" (see 3.11);
--- Changed "Expected Performance" (see Chapter 4, Chapter 4 of the.2011 edition);
--- Changed the "General requirements" of design attributes (see 5.1, 5.1 of the.2011 edition);
--- Changed "Ingredient Characteristics" (see 5.2, 5.2 of the.2011 edition);
--- Changed "Chemical and biological pollutants" (see 5.3.3, 5.3.3 of the.2011 edition);
--- Changed "concentration/content" (see 5.3.4, 5.3.4 of the.2011 edition);
--- Changed "particles" (see 5.3.8, 5.3.8 of the.2011 edition);
--- Added "visible foreign matter" (see 5.3.13);
--- Added "load" (see 5.3.14);
--- Added "Availability" (see 5.4);
--- Changed the "General requirements" for design evaluation (see 6.1, 6.1 of the.2011 edition);
--- Changed the "Bacterial endotoxin test" (see 6.2.2, 6.2.2 of the.2011 edition);
--- Deleted "Cytotoxicity test" (see 6.2.6 of the.2011 edition);
--- Deleted "skin sensitization test" (see 6.2.7 of the.2011 edition);
--- Deleted "Clinical evaluation" (see 6.3 of the.2011 edition);
--- Changed "Sterilization" (see Chapter 7, Chapter 7 of the.2011 edition);
--- Changed "Product Stability" (see Chapter 8, Chapter 8 of the.2011 edition);
--- Changed "Information provided by the manufacturer" (see Chapter 11, Chapter 11 of the.2011 edition);
--- Changed the “Intraocular implantation test” (see Appendix A, Appendix A of the.2011 edition).
This document is modified to adopt ISO 15798.2022 “Ophthalmic implants - Ophthalmic adhesive devices”.
The technical differences between this document and ISO 15798.2022 and their reasons are as follows.
--- Deleted "lost cases" (see 3.5 of ISO 15798.2022) to adapt to my country's technical conditions;
--- Changed "Concentration/content" (see 5.3.4, 5.3.4 of ISO 15798.2022), added the description of content, supplemented the product performance index
Label, increase operability;
--- Changed "Osmotic pressure" (see 5.3.7, 5.3.7 of ISO 15798.2022) to adapt to my country's technical conditions and increase operability;
--- Added normative references to the Pharmacopoeia of the People's Republic of China (Part 4) (see 5.3.7) to adapt to my country's technical conditions, and added
Operability;
--- Changed "particles" (see 5.3.8, 5.3.8 of ISO 15798.2022), added the particle limit value of the product, clarified the specific
performance indicators to increase operability;
--- Added "visible foreign matter" (see 5.3.13), added the requirement that the product should be free of visible foreign matter, supplemented the product performance indicators, and ensured that the product
The safety and effectiveness of the product;
--- Added "filling volume" (see 5.3.14), added the requirements for the minimum filling volume and average filling volume of the product, supplemented the product performance indicators, and ensured
The safety and effectiveness of the product;
--- Changed the "Bacterial endotoxin test" (see 6.2.2, 6.2.2 of ISO 15798.2022) to adapt to my country's technical conditions, and added
Operability;
--- "Clinical evaluation" (see 6.3 of ISO 15798.2022) has been deleted to adapt to my country's technical conditions;
--- Deleted the normative references to ISO 14155 and EN1041 (see 6.3.1 and Chapter 11 of ISO 15798.2022) to adapt to my country
technical conditions.
The following editorial changes were made to this document.
--- Changed the standard name;
--- Deleted "Appendix B (informative) Number of patients in clinical investigation of intraocular pressure" (see Appendix B of ISO 15798.2022);
--- Deleted "Appendix C (informative) Clinical data analysis of ophthalmic viscoelastics" (see Appendix C of ISO 15798.2022).
Please note that some of the contents of this document may involve patents. The issuing organization of this document does not assume the responsibility for identifying patents.
This document is proposed and coordinated by the State Food and Drug Administration.
The previous versions of this document and the documents it replaces are as follows.
---First released in.2011 as YY 0861-2011;
---This is the first revision.
Ophthalmic Optical Viscoelastics
1 Scope
This document specifies the expected performance, design attributes, design evaluation, sterilization, product stability, and delivery system integrity of ophthalmic viscoelastics.
and performance, packaging and information provided by the manufacturer.
This document applies to viscoelastics for ophthalmic use (hereinafter referred to as "viscoelastics").
2 Normative references
The contents of the following documents constitute essential clauses of this document through normative references in this document.
For referenced documents without a date, only the version corresponding to that date applies to this document; for referenced documents without a date, the latest version (including all amendments) applies 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 16886.6 Biological evaluation of medical devices Part 6.Local reaction test after implantation (GB/T 16886.6-2022,
ISO 10993-6.2016, IDT)
GB/T 16886.7 Biological evaluation of medical devices Part 7.Ethylene oxide sterilization residues (GB/T 16886.7-2015,
ISO 10993-7.2008, IDT)
GB/T 16886.9 Biological evaluation of medical devices Part 9.Qualitative and quantitative framework for potential degradation products
(GB/T 16886.9-2022,ISO 10993-9.2019,IDT)
GB/T 16886.16 Biological evaluation of medical devices Part 16.Toxicokinetic study design of degradation products and leachables
(GB/T 16886.16-2021,ISO 10993-16.2017,IDT)
GB 18278.1 Sterilization of health care products by moist heat Part 1.Development, validation and routine control of sterilization processes for medical devices
Request (GB 18278.1-2015, ISO 17665-1.2006, IDT)
GB 18279 Sterilization of healthcare products - Development, validation and routine control requirements for ethylene oxide sterilization processes for medical devices
(GB 18279-2023, ISO 11135.2014, MOD)
GB 18280.1 Radiation sterilization of health care products Part 1.Development, validation and routine control of sterilization processes for medical devices
Request (GB 18280.1-2015, ISO 11137-1.2006, IDT)
GB 18280.2 Radiation sterilization of health care products Part 2.Establishing the sterilization dose (GB 18280.2-2015,
ISO 11137-2.2006, IDT)
GB/T 18280.3 Radiation sterilization of health care products Part 3.Guide to dose measurement (GB/T 18280.3-2015,
ISO 11137-3.2006, 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 42062 Application of medical device risk management to medical devices (GB/T 42062-2022, ISO 14971.2019,
IDT)
YY/T 0567.1 Aseptic processing of health care products Part 1.General requirements (YY/T 0567.1-2013, ISO 13408-
1.2008,IDT)
YY/T 0771.1 Medical devices of animal origin Part 1.Application of risk management (YY/T 0771.1-2020, ISO 22442-1.
2015,MOD)
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