This document specifies requirements with regard to the intended performance, design attributes, design evaluation, sterilization, product stability, integrity and performance of delivery system, packaging, and information to be supplied by the manufacturer of ophthalmic viscosurgical devices (OVDs).
This document is applicable to OVDs.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2022, ISO 10993-1:2018, IDT)
GB/T 16886.6 Biological evaluation of medical devices - Part 6: Tests for local effects 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 residuals (GB/T 16886.7-2015, ISO 10993-7:2008, IDT)
GB/T 16886.9 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of 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 for degradation products and leachables (GB/T 16886.16-2021, ISO 10993-16:2017, IDT)
GB 18278.1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18278.1-2015, ISO 17665-1:2006, IDT)
GB 18279 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18279-2023, ISO 11135:2014, MOD)
GB 18280.1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (GB 18280.1-2015, ISO 11137-1:2006, IDT)
GB 18280.2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (GB 18280.2-2015, ISO 11137-2:2006, IDT)
GB/T 18280.3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (GB/T 18280.3-2015, ISO 11137-3:2006, 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)
GB/T 42062 Medical devices - Application of 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 utilizing animal tissues and their derivatives - Part 1: Application of risk management (YY/T 0771.1-2020, ISO 22442-1:2015, MOD)
YY/T 0771.2 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (YY/T 0771.2-2020, ISO 22442-2:2015, MOD)
YY/T 0771.3 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents (YY/T 0771.3-2009, ISO 22442-3:2007, IDT)
Pharmacopoeia of the People's Republic of China (Volume IV)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
complex viscosity
η*=η′-i×η″
where,
η*——the complex viscosity;
η′——the viscous component;
η″——the elastic component;
i——the imaginary number defined by
3.2
absolute complex viscosity
absolute value of complex viscosity (3.1)
Note: Absolute complex viscosity is expressed in pascal seconds (Pa·s).
3.3
delivery system
primary container in which the product is supplied and any additional components provided to introduce the product into the eye
3.4
elasticity
tendency of a material to return to its original shape after having been deformed by an external force and then the force is removed
G′=σ0/ε0·cosδ
where,
G′——the elasticity, expressed in pascal (Pa);
σ0——the stress (force per unit area);
ε0——the strain (the relative change in dimensions of the body);
cosδ——the cosine of the phase lag between stress and strain
Foreword II 1 Scope 2 Normative references 3 Terms and definitions 4 Intended performance 5 Design attributes 5.1 General 5.2 Characterization of the components 5.3 Characterization of the finished product 5.4 Usability 6 Design evaluation 6.1 General 6.2 Evaluation of biological safety 7 Sterilization 8 Product stability 9 Integrity and performance of the delivery system 10 Packaging 10.1 Protection from damage during storage and transport 10.2 Maintenance of sterility in transit 11 Information to be supplied by the manufacturer Annex A (Normative) Intraocular implantation test Bibliography
YY 0861-2024 Ophthalmic optics - Ophthalmic viscosurgical devices
1 Scope
This document specifies requirements with regard to the intended performance, design attributes, design evaluation, sterilization, product stability, integrity and performance of delivery system, packaging, and information to be supplied by the manufacturer of ophthalmic viscosurgical devices (OVDs).
This document is applicable to OVDs.
2 Normative references
The following documents contain provisions which, through reference in this text, constitute provisions of this document. For dated references, only the edition cited applies. For undated references, the latest edition of the referenced document (including any amendments) applies.
GB/T 16886.1 Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process (GB/T 16886.1-2022, ISO 10993-1:2018, IDT)
GB/T 16886.6 Biological evaluation of medical devices - Part 6: Tests for local effects 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 residuals (GB/T 16886.7-2015, ISO 10993-7:2008, IDT)
GB/T 16886.9 Biological evaluation of medical devices - Part 9: Framework for identification and quantification of 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 for degradation products and leachables (GB/T 16886.16-2021, ISO 10993-16:2017, IDT)
GB 18278.1 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18278.1-2015, ISO 17665-1:2006, IDT)
GB 18279 Sterilization of health-care products - Ethylene oxide - Requirements for the development, validation and routine control of a sterilization process for medical devices (GB 18279-2023, ISO 11135:2014, MOD)
GB 18280.1 Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices (GB 18280.1-2015, ISO 11137-1:2006, IDT)
GB 18280.2 Sterilization of health care products - Radiation - Part 2: Establishing the sterilization dose (GB 18280.2-2015, ISO 11137-2:2006, IDT)
GB/T 18280.3 Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects (GB/T 18280.3-2015, ISO 11137-3:2006, 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)
GB/T 42062 Medical devices - Application of 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 utilizing animal tissues and their derivatives - Part 1: Application of risk management (YY/T 0771.1-2020, ISO 22442-1:2015, MOD)
YY/T 0771.2 Medical devices utilizing animal tissues and their derivatives - Part 2: Controls on sourcing, collection and handling (YY/T 0771.2-2020, ISO 22442-2:2015, MOD)
YY/T 0771.3 Medical devices utilizing animal tissues and their derivatives - Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents (YY/T 0771.3-2009, ISO 22442-3:2007, IDT)
Pharmacopoeia of the People's Republic of China (Volume IV)
3 Terms and definitions
For the purposes of this document, the following terms and definitions apply.
3.1
complex viscosity
η*=η′-i×η″
where,
η*——the complex viscosity;
η′——the viscous component;
η″——the elastic component;
i——the imaginary number defined by
3.2
absolute complex viscosity
absolute value of complex viscosity (3.1)
Note: Absolute complex viscosity is expressed in pascal seconds (Pa·s).
3.3
delivery system
primary container in which the product is supplied and any additional components provided to introduce the product into the eye
3.4
elasticity
tendency of a material to return to its original shape after having been deformed by an external force and then the force is removed
G′=σ0/ε0·cosδ
where,
G′——the elasticity, expressed in pascal (Pa);
σ0——the stress (force per unit area);
ε0——the strain (the relative change in dimensions of the body);
cosδ——the cosine of the phase lag between stress and strain
Contents of YY 0861-2024
Foreword II
1 Scope
2 Normative references
3 Terms and definitions
4 Intended performance
5 Design attributes
5.1 General
5.2 Characterization of the components
5.3 Characterization of the finished product
5.4 Usability
6 Design evaluation
6.1 General
6.2 Evaluation of biological safety
7 Sterilization
8 Product stability
9 Integrity and performance of the delivery system
10 Packaging
10.1 Protection from damage during storage and transport
10.2 Maintenance of sterility in transit
11 Information to be supplied by the manufacturer
Annex A (Normative) Intraocular implantation test
Bibliography
