YY/T 0953-2020 in English
VALIDMedical carboxymethyl chitosan
- Issued on:2020-09-27
- Implemented on:2021-09-01
- File Format:PDF
- Delivery:Via email within 5 business days
$330.00
本标准规定了医用羧甲基壳聚糖原料的要求、试验方法、包装、运输、贮存等。
本标准适用于以壳聚糖或甲壳素为原料，经脱乙酰化、羧化、纯化而成的用于制造组织工程医疗器械产品的医用羧甲基壳聚糖。
Introduction
Analysis of the core content of the standard
| Indicators | Requirements for the 2020 version | Changes in the 2015 version |
|---|---|---|
| Degree of substitution (DS) | ≥80% | New infrared spectroscopy verification method |
| Intrinsic viscosity | 1.0-3.0 dL/g | Test method optimization |
| Heavy metal limits | Pb≤10μg/g | New ICP-MS detection method |
Key Technical Requirements
Carboxymethyl chitosan is the core material of medical dressings. The standard stipulates 12 key indicators:
- Infrared characteristic absorption peaks: 3250-3450cm-1(OH/NH), 1600cm-1(COO-) and other characteristic peaks need to match the spectrum in Appendix A
- Moisture content: Determined by GB/T 14233.1 method, ≤15%
- Protein residue: Determined by Coomassie Brilliant Blue method, ≤0.2%
Key points for implementation of biological evaluation
Based on GB/T The 16886 series of standards require that the following evaluations must be completed:
- Cytotoxicity: MTT assay to detect extract cell survival rate ≥ 70%
- Sensitization: Guinea pig maximization test
- Implantation test: PMMA material control, observe inflammatory response for 14 days
In clinical applications, special attention should be paid to the pH changes that may be caused by the degradation products of carboxymethyl chitosan (the standard requires 6.0-8.0).
Standard Evolution Analysis
Main improvements compared to the 2015 version:
- Add molecular weight distribution detection (Appendix D uses MALS-GPC combined method)
- Optimize the detection limit of residual solvents (GC method detection T≤0.1%)
- Supplement special requirements for ethylene oxide residues
Application suggestions
Key control points in the production process:
| Process links | Key parameters |
| Carboxymethylation reaction | Temperature 40±2℃, pH 10-11 |
| Purification treatment | Ultrafiltration molecular weight cut-off 10kDa |
Complete characterization data of carboxymethyl chitosan raw materials, including XRD crystallinity analysis, should be provided when registering the product.
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