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美国口罩510(k)注册送检项目
来源: | 作者:Coco Ke | 发布时间: 2020-09-18 | 163 次浏览 | 分享到:

一、 产品性能  

序号

性能

检测标准

1

Fluid Resistance(合成血液渗透)

ASTM F 1862: Standard Test Method for Resistance of Surgical Mask to Penetration by Synthetic Blood

2

Particulate Filtration Efficiency(颗粒过滤效率)

ASTM F 1215-89 Standard Test Method for Determining the Initial Efficiency of Flatsheet Filter Medium in an Airflow Using Latex Spheres.

3

Bacterial Filtration Efficiency(细菌过滤效率)

ASTM F 2101-01 Standard Test Method for Evaluating the Bacterial Filtration Efficiency (BFE) of surgical masks using a Biological Aerosol of Staphylococcus aureus.

4

Differential Pressure (Delta-P) Test(压差)

MIL-M-36945C 4.4.1.1.1 Method 1 Military Specifications: Surgical Mask, disposable (June 12, 1975)

5

Flammability Testing(阻燃性)

CPSC CS-191-53 Flammability Test Method (16 CFR 1610) Standard for Flammability of Clothing Textiles


二、生物相容性

Biocompatibility(生物相容性)

体外细胞毒性

ISO 10993-5, Biological evaluation of medical device – Part 5: Tests for in vitro cytotoxicity (2009).

皮肤刺激

ISO10993-10, Biological evaluation of medical devices - Part 10: Tests for irritation and skin sensitization (2010).

致敏


        FDA
注册要求按照ISO10993的最新版本检测,做双极性试验,出GLP报告。