US Requirements for Sharps Containers
US Requirements for Sharps Containers
Reviewed: Jan 14th 2013 (TG)
|FDA Regulations |Yes/No | | | | |
|All sharps containers | | | | | |
|510(k) available | | | | | |
|Compliant with CFR 21 Part 820 Quality System Regulation and Good Manufacturing Practices. | | | | | |
|Labeled with clear directions for safe use | | | | | |
|OSHA compliant (Closable, Puncture resistant. Label/color-coded, Leak resistant when | | | | | |
|upright) | | | | | |
|Puncture Resistant (base, sides, closure, top) | | | | | |
|Reusable Sharps Containers | | | | | |
|510(k) performance tests included: | | | | | |
|Repeated filling and emptying container of sharps, equal to stated lifespan-uses, using | | | | | |
|normal processing | | | | | |
|DOT Vibration test | | | | | |
|Passes Impact Resistance, Puncture Test, Leak Test after above lifespan-use simulation | | | | | |
| | | | | | |
|DOT Regulations |Yes/No | | | | |
|All sharps containers | | | | | |
|DOT UN Specification Packaging Tests (Containers ................
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