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Outline
This study aims to systematically compare the differences in cytotoxicity evaluation of disposable infusion sets between the weight-based and inner surface area-based extraction methods, as well as between the two standards GB/T 16886.5—2017 and GB/T 14233.2—2005. The goal is to establish an extraction protocol that more accurately reflects the clinical biological safety risk characteristics.
A clinically standard disposable infusion set was selected as the research object. Based on the two standards, two extraction solutions were prepared. ①Weight-based method: 0.2 g/mL of the cut material added to MEM medium containing serum; ②Inner surface area method: 6 cm2/mL of MEM medium containing serum filled into the lumen of the infusion set. Both were extracted under shaking conditions (37 ℃, 60 rpm) for 72 hours. The extracts were then subjected to comparative in vitro cytotoxicity testing.
Qualitative results indicated that cytotoxic responses varied under different standards. According to GB/T 16886.5—2017, the 100% extracts from both extraction methods exhibited mild cytotoxicity (Grade 2), whereas under GB/T 14233.2—2005, they both showed moderate cytotoxicity (Grade 3). Quantitative results revealed that, regardless of the standard used, the inner surface area extraction method consistently yielded higher cytotoxicity than the weight-based method. Notably, under GB/T 16886.5—2017, a significant difference in cell viability was observed between the two extraction methods (P<0.001).
For lumen-type devices such as infusion sets, employing the inner surface area extraction method in strict accordance with GB/T 16886.5 provides a more realistic reflection of clinical biological safety risks. It is also crucial to recognize methodological differences between standards. The more sensitive GB/T 14233.2 is recommended for risk screening during product release and batch consistency monitoring. Conversely, for medical device registration review and systemic biological evaluation, a comprehensive assessment strategy based on the inner surface area extraction within the GB/T 16886.5 framework should be prioritized.
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| 科 Family | 属数 Number of genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) | 属 Genus | 种数 Number of species | 占总种数比例 Percentage of total species (%) |
|---|---|---|---|---|---|---|
| 鹅膏菌科Amanitaceae | 2 | 11 | 5.26 | 鹅膏菌属 Amanita | 10 | 4.78 |
| 小菇科 Mycenaceae | 2 | 12 | 5.74 | 丝盖伞属 Inocybe | 5 | 2.39 |
| 多孔菌科 Polyporaceae | 8 | 14 | 6.70 | 蜡蘑属 Laccaria | 5 | 2.39 |
| 红菇科 Russulaceae | 3 | 23 | 11.00 | 小皮伞属 Marasmius | 6 | 2.87 |
| 小菇属 Mycena | 11 | 5.26 | ||||
| 光柄菇属 Pluteus | 5 | 2.39 | ||||
| 红菇属 Russula | 17 | 8.13 | ||||
| 栓菌属 Trametes | 5 | 2.39 |
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