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YY 0861-2024Ophthalmic optics - Ophthalmic viscosurgical devices (English PDF)

眼科光学眼用粘弹剂

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Issued by

NMPA

Level / Type

Industry · Mandatory

Issue date

July 8, 2024

Implementation date

July 20, 2027

Scope

YY 0861-2024 is the English-translated version of 眼科光学眼用粘弹剂.

YY 0861-2024 is the Chinese standard "Ophthalmic optics - Ophthalmic viscosurgical devices".

Its scope clause reads: 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").

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Document preview — YY 0861-2024

National Standard of the People's Republic of China

ICS: 11.040.70
Classification: C40
Replacing: YY 0861-2011

Issued by: National Medical Products Administration

Preface
1 Scope
2 Normative references
3 Terms and Definitions
4 Expected Performance
5 Design attributes
5.1 General requirements
5.2 Ingredient characteristics
5.3 Finished product characteristics
5.4 Availability
6 Design Evaluation
6.1 General requirements
6.2 Biological safety assessment
7 Sterilization
8 Product Stability
9 Conveyor System Integrity and Performance
10 Packaging
10.1 Damage prevention during storage and transportation
10.2 Maintaining Sterility During Transport
11 Information provided by the manufacturer
Appendix A (Normative) Intraocular implantation test

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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This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 17 pages — is available in the English PDF.

Referenced standards

Normative references

ISO 10993 · ISO 17665 · ISO 11135.2014 · ISO 11137

Similar standards

YY/T 0842|YY 0843|YY 0847|YY/T 0862|YY/T 0871

Editions of YY 0861

Edition	Title	Revision	Status
YY 0861-2024	Ophthalmic optics - Ophthalmic viscosurgical devices	current edition	Current
YY 0861-2011	Ophthalmic optics - Ophthalmic viscosurgical devices	previous edition	In force until 2027-07-20

This page sells the current edition, YY 0861-2024. Earlier editions are listed for reference only.

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