ISO/TC 198
| Project No. | ISO 11737-3:2004 |
|---|---|
| Title | <p>ISO 11737-3:2004 provides guidance on evaluating and interpreting the data generated during routine monitoring of the microbiological quality of medical devices.</p> <p>ISO 11737-3:2004 is not applicable to the use of bioburden data generated for establishing the extent of treatment to be applied in a sterilization process. </p> <p>ISO 11737-3:2004 is not applicable to microbiological data generated from sampling the environment in manufacturing areas.</p> |
| Registration number (WIID) | 33964 |
| Scope | <p>ISO 11737-3:2004 provides guidance on evaluating and interpreting the data generated during routine monitoring of the microbiological quality of medical devices.</p> <p>ISO 11737-3:2004 is not applicable to the use of bioburden data generated for establishing the extent of treatment to be applied in a sterilization process. </p> <p>ISO 11737-3:2004 is not applicable to microbiological data generated from sampling the environment in manufacturing areas.</p> |
| Status | Atcelts |
| ICS group | 07.100.10 11.080.01 |