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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