Testing Requirements
Material |
Item |
Requirement |
Standard |
|
Polyvinyl chloride |
Residual vinyl chloride monomer |
≤0.01mg/kg |
21 CFR 177.1975 |
|
Disposable |
Chloroform soluble extract-distilled water |
≤0.5mg/inch2/ ≤1.8mg/inch2 |
21 CFR 175.300 |
|
Chloroform soluble extract-8% ethanol | ||||
Chloroform soluble extract-n-heptane | ||||
Reusable |
Chloroform soluble extract-distilled water |
≤18mg/inch2 |
||
Chloroform soluble extract-8% ethanol | ||||
Chloroform soluble extract-n-heptane | ||||