ASTM D 3577 一次性使用灭菌橡胶外科手套
Standard Specification for Rubber Surgical Gloves

Clause

Test Requirement

3

Classification等级

4

Materials and Manufacture材料和制造

6

Sampling (ISO2859)抽样(ISO2859)

7

Performance Requirements性能需求

7.1.1

Sterility Test无菌试验

7.1.2

Freedom From Holes针孔控制水平 

7.1.3

Physical Dimensions Test物理尺寸测试

7.1.4

Physical Requirements Test物理需求测试

7.1.5

Powder residue limit (only for power free gloves)(ASTM D 6124)
粉末残留限量(仅适用于无电手套)(ASTM D 6124)

7.1.6

Aqueous Extractable Protein Content水溶性可提取蛋白质含量

7.1.7

Powder limit(only for powered gloves)(ASTM D 6124)
粉末限制(仅适用于动力手套)(ASTM D 6124)

10

Packaging and Marking包装和标志

Sample required: 360 pieces of gloves for physical test, 180 pieces for sterility test， 100g gloves for Aqueous Extractable Protein Content test
样品要求: 360个手套用于物理性能测试，180个手套用于无菌测试，100g手套用于水溶性蛋白的测试

Turnaround time: 15 working days for physical test, 33wd for sterility test， 23wd for protein content test
所需时间: 物理测试15 个工作天，  无菌测试33个工作日，水溶蛋白测试23个工作日