| Certificate/Reg.-No. | 968/FSP 1976.04/23 |
| Type of Certificate | A-FS&CS Certificate |
| Certificate Holder | BlackBerry Limited |
| Manufacturer | BlackBerry Limited |
| Product Category | Software > Others Compliant Items |
| Subject | Hypervisor |
| Type Designation | QNX Hypervisor for Safety (QHS) for released and approved versions refer to the "Revision List" |
| Codes and Standards |
|
| Scope and Result | The evaluation of the Certification Body came to the result that the QHS product complies with the requirements of the relevant standards (ASIL D according to ISO 26262, SC 3 according to IEC 61508 and Class C according to IEC 62304) and can be used as a Safety Element Out Of Context (SEooC) in items in order to realize safety goals up to ASIL D according to ISO 26262, as a compliant item in applications up to SIL 3 according to IEC 61508 and medical devices complying with the requirements of IEC 62304 at software level A, B or C. |
| Specific Provisions | For the use of the QHS the operating conditions and functional characteristics as specified in the Safety Manual and accompanying 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 risk management according to ISO 14791 required by standard IEC 62304 is excluded from scope of certification. These process activities need to be established by the medical device manufacturer of a product while developing a medical device. |
| Valid Until | no expiry date |
| Appendixes |
FSP_1976_04_23_RL_2023_06_14_QHS_2_2 FSP_1976_04_23_RL_2023_06_14_QHS_2_2_2 FSP_1976_04_23_RL_2023_08_10_QHS_2_2_4 FSP_1976_04_23_RL_2023_12_08_QHS_2_2_5.pdf |
| Download Certificate | 968_FSP_1976_04_23_en_el.pdf |
| Certificate/Reg.-No. | Certificate Holder | Product Category | Product Tested | Type Designation | Details |
|---|
| 968/FSP 1976.04/23 | BlackBerry Limited | Software → Others | Hypervisor | QNX Hypervisor for Safety (QHS) for released and approved versions refer to the "Revision List" | View Details | View PDF |
| 968/FSP 1976.04/23 | BlackBerry Limited | Compliant Items | Hypervisor | QNX Hypervisor for Safety (QHS) for released and approved versions refer to the "Revision List" | View Details | View PDF |
Remark: In case of missing entries this is due to restrictions by the certificate holder
