YY/T 0862-2023Ophthalmic optics - Ocular endotamponades (English PDF)
眼科光学 眼内填充物
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Issued by
NMPA
Level / Type
Industry · Recommended
Issue date
March 14, 2023
Implementation date
May 1, 2024
Scope
YY/T 0862-2023 is the English-translated version of 眼科光学 眼内填充物.
YY/T 0862-2023 is the Chinese standard "Ophthalmic optics - Ocular endotamponades".
Its scope clause reads: This 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:. Its clauses include terms and definitions.
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Document preview — YY/T 0862-2023
National Standard of the People's Republic of China
- ICS
- 11.040.70
- Classification
- C40
- Replacing
- YY/T 0862-2011
Issued by: National Medical Products Administration
Contents
- Preface
- 1 Scope
- 2 Normative references
- 3 Terms and Definitions
- 4 Expected performance
- 5 Design attributes
- 6 Design Evaluation
- 7 Sterilization
- 8 Product Stability
- 9 Conveyor System Integrity and Performance
- 10 packs of
- 11 Information provided by the manufacturer
- Appendix A (informative) Method for quantifying incompletely fluorinated pollutants in perfluorocarbon liquids
- Appendix B (Normative) Eye Implantation Test
1 Scope
This 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 references
The 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 Four
3 Terms and Definitions
The 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):
......
This preview omits tables, figures, formulas and parts of the technical clauses. The complete document — 15 pages — is available in the English PDF.
Referenced standards
Normative references
- GB/T 42062-2022Medical devices - Application of risk management to medical devices
- YY/T 0640-2016Non-active surgical implants - General requirements
GB/T 16886 · ISO 10993 · GB/T 19633 · ISO 11607 · ISO 14971 · YY/T 0466 · ISO 15223 · YY/T 0567 · ISO 13408 · ISO 14630
Editions of YY/T 0862
| Edition | Title | Revision | Status |
|---|---|---|---|
| YY/T 0862-2023 | Ophthalmic optics - Ocular endotamponades | current edition | Current |
| YY/T 0862-2011 | Ophthalmic optics - Ocular endotamponades | previous edition | In force until 2024-05-01 |
This page sells the current edition, YY/T 0862-2023. Earlier editions are listed for reference only.
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Related Standards
GB/T 16886.1-2022 — Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process
GB/T 16886.10-2024 — Biological evaluation of medical devices - Part 10: Tests for skin sensitization
GB/T 16886.11-2021 — Biological evaluation of medical devices - Part 11: Tests for systemic toxicity
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