| Certificate/Reg.-No. | 968/EZ 653.13/20 |
| Type of Certificate | A-FS&CS Certificate |
| Certificate Holder | BlackBerry Limited |
| Product Category | Software > RTOS Compliant Items |
| Subject | Real Time Operating System (RTOS) |
| Type Designation | QNX OS for Safety (QOS) for released and approved versions refer to the "Revision List" |
| Codes and Standards |
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| Scope and Result | The QOS 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. The provided tool chain, classified as TCL3 and T3, complies with the applicable requirements for supporting tools according to ISO 26262-8 and off-line support tools according to IEC 61508-3. The C++ library (libcxx) may be used in order to achieve safety goals up to ASIL B according to ISO 26262. |
| Specific Provisions | For the use of the QOS 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 |
EZ_653_13_20_RL_2020-11-02_QOS_2_2.pdf EZ_653_13_20_RL_2021-11-26_QOS_1_0_2.pdf EZ_653_13_20_RL_2021-11-26_QOS_1_0_3.pdf EZ_653_13_20_RL_2022_08_04_QOS_2_2_1.pdf EZ_653_13_20_RL_2024_04_19_QOS_2_1_2.pdf EZ_653_13_20_RL_2024_04_19_QOS_2_1_3.pdf |
| Download Certificate | 968_EZ_653_13_20_en_el.pdf |
| Certificate/Reg.-No. | Certificate Holder | Product Category | Product Tested | Type Designation | Details |
|---|
| 968/EZ 653.13/20 | BlackBerry Limited | Software → RTOS | Real Time Operating System (RTOS) | QNX OS for Safety (QOS) for released and approved versions refer to the "Revision List" | View Details | View PDF |
| 968/EZ 653.13/20 | BlackBerry Limited | Compliant Items | Real Time Operating System (RTOS) | QNX OS for Safety (QOS) 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
