Certificate/Reg.-No. | 968/FSP 1779.00/18 |
Type of Certificate | A-FS&CS Certificate |
Certificate Holder | Embedded Office GmbH & Co. KG |
Product Category | Software > Others Compliant Items |
Subject | Diagnostic software test libraries |
Type Designation | Safety AddOns – Safety Timing and E2E – Protection Modules as listed in the current revision list |
Codes and Standards |
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Scope and Result | The Safety AddOns for the µC/OS II-MPU Real-Time Operating System of Embedded Office GmbH & Co. KG comply with the requirements of SC 3 acc. to IEC 61508, ASIL D (SEooC) acc. to ISO 26262. The claimed diagnostic coverages of 90% (medium) for Program Flow Monitor / Time Budget Watchdog and 99% (high) for E2E protection for inter-task communication and the combination of Program Flow Monitor and Time Budget Watchdog can be confirmed. 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 EN 62304 is excluded from scope of the certification. These process activities need to be established by the user of the product while developing a medical device. |
Valid Until | 2023-12-03 (Certificate expired) |
Appendixes | FSP_1779_00_18_RL_2018_12_03.pdf |
Download Certificate | 968_FSP_1779_00_18_en_el.pdf |
Certificate/Reg.-No. | Certificate Holder | Product Category | Product Tested | Type Designation | Details |
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968/FSP 1779.00/18expired | Embedded Office GmbH & Co. KG | Software → Others | Diagnostic software test libraries | Safety AddOns – Safety Timing and E2E – Protection Modules as listed in the current revision list | View Details | View PDF |
968/FSP 1779.00/18expired | Embedded Office GmbH & Co. KG | Compliant Items | Diagnostic software test libraries | Safety AddOns – Safety Timing and E2E – Protection Modules as listed in the current revision list | View Details | View PDF |
Remark: In case of missing entries this is due to restrictions by the certificate holder