sorin XTRA - Appendix B: Approvals and Test Certificate; EMC Standards; EMC Emission; EMC Immunity

XTRA Operator’s Manual 20077/021 US B-1
Appendix B: Approvals and Test Certificate
The XTRA and XVAC equipment have been tested and comply with the following:
EMC Standards
(See Appendix A: Safety Standards EN 60601-1-2 )
EMC Emission
• IEC 60601-1-2 : 2007 and : 2014
EMC Immunity
• IEC 60601-1-2 : 2007 and : 2014
Electrical and Mechanical Safety Standards
• IEC 60601-1 Edition 3.1
Certification
•C-US NRTL Certification
• CB Certification
The LivaNova quality assurance system complies with the following standards:
• UNI - EN - ISO - 13485