YY 0861-2024 in English
TO BE VALIDOphthalmic optics—Ophthalmic viscosurgical devices
- Issued on:2024-07-08
- Implemented on:2027-07-20
- File Format:PDF
- Delivery:Via email within 2~4 business days
$436.00
| Standard No: | YY 0861-2024 |
| Document status: | TO BE VALID |
| Title in English: | Ophthalmic optics—Ophthalmic viscosurgical devices |
| Title in Chinese: | 眼科光学 眼用粘弹剂 |
| Language: | English |
| File Format: | Electronic (PDF) |
| Delivery: | Via email within 2~4 business days |
| Issued on: | 2024-07-08 |
| Implemented on: | 2027-07-20 |
| ICS Classification: | 11.040.70-Ophthalmic equipment |
| Chinese Classification: | C40-Medical optical instrument and endoscope |
| Professional Classification: | YY-Pharmaceutics |
| Related Keywords: | ophthalmic optics ophthalmic
ophthalmic viscoelastics viscosurgical devices introduction core changes ophthalmic injection fluidity clinical application case |
Introduction
Core changes in the standard revision
| Technical parameters | YY 0861-2011 | YY 0861-2024 | Significance of changes |
|---|---|---|---|
| Particle control | No quantitative indicator | 10μm≤3000 particles/mL 25μm≤300 particles/mL | Clear surgical safety threshold |
| Visible foreign matter | Not required | New test items | Prevention of postoperative complications |
| Sterilization requirements | Conventional sterilization | Increase EO residue control | Improve biocompatibility |
Analysis of key technical requirements
Rheological properties
The standard requires the measurement of the absolute complex viscosity (η*) of ophthalmic viscoelastics in the frequency range of 0.01-100Hz, where:
- Zero shear viscosity reflects static protection ability
- Elastic modulus (G') determines spatial maintenance
- Viscous modulus (G'') affects injection fluidity
Clinical application case: During cataract surgery, high-elastic viscoelastics are more suitable for maintaining anterior chamber space, while low-shear viscosity products are more conducive to injection through a narrow-bore cannula.
Analysis of differences in international standards
Compared with ISO 15798:2022, my country's standard mainly strengthens:
- Add the detection method of the "Chinese Pharmacopoeia" (osmotic pressure, visible foreign matter, etc.)
- Refine the quantitative indicators such as particle limit
- Delete the clinical evaluation chapter (in line with domestic regulatory requirements)
Implementation Recommendations
Manufacturers
- Establish a database correlating rheological properties and clinical performance
- Strengthen the compatibility verification of primary packaging (such as silicone oil migration risk)
- Use real-time aging test to verify product stability
Medical institutions
- Preoperative inspection of viscoelastic agent packaging integrity
- Pay attention to the cleaning method instructions in the product manual
- Record changes in rheological properties during surgery (such as viscosity decrease after phacoemulsification)
Technology evolution trend
Next-generation products will focus on:
- Intelligent responsive viscoelastic agents (pH/temperature sensitive)
- Integration of anti-inflammatory drug sustained-release function
- Application of biodegradable materials
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