| Certificate/Reg.-No. | 968/EZ 564.14/18 |
| Type of Certificate | A-FS&CS Certificate |
| Certificate Holder | Embedded Office GmbH & Co. KG |
| Manufacturer | Embedded Office GmbH & Co. KG |
| Product Category | Software > RTOS |
| Subject | Real Time Operating System (RTOS) |
| Type Designation | uC/OS-II RTOS Software with MPU extension for released and approved versions refer to "Revision List" |
| Codes and Standards |
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| Scope and Result | The software complies with the requirements of the relevant standard (SC 3 acc. to IEC 61508) and can be used in applications up to SIL 3 acc. to IEC 61508. The product was also reviewed in reference to the applicable requirements of EN 62304:2006 + Cor.: 2008 + A1:2015 Class C, applicable during a type examination and be used in applications as such. |
| Specific Provisions | For the use of the software the operating conditions and functional characteristics as specified in the Safety Manual and accompanying development documents provided by the manufacturer needs to be observed. The current versions of software are specified in the currently valid revision list. The list is released by the manufacturer in cooperation with the certification body. The Software Risk Management Process required by standard EN 62304 is excluded from scope of the certification. These process activities need to be established by the end user of product while developing a medical device. |
| Valid Until | 2023-11-28 (Certificate expired) |
| Appendixes | EZ_564_14_18_RL_2018_11_28.pdf |
| Download Certificate | 968_EZ_564_14_18_de_en_el.pdf |
| Certificate/Reg.-No. | Certificate Holder | Product Category | Product Tested | Type Designation | Details |
|---|
| 968/EZ 564.14/18expired | Embedded Office GmbH & Co. KG | Software → RTOS | Real Time Operating System (RTOS) | uC/OS-II RTOS Software with MPU extension for released and approved versions refer to "Revision List" | View Details | View PDF |
Remark: In case of missing entries this is due to restrictions by the certificate holder
