GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases
GOST ISO 10993-1-2011 Medical devices. Biological evaluation of medical devices. Part 1. Evaluation and testing
GOST ISO 10993-10-2011 Medical devices. Biological evaluation of medical devices. Part 10. Tests for irritation and delayed-type hypersensitivity
GOST ISO 10993-11-2011 Medical devices. Biological evaluation of medical devices. Part 11. Tests for systemic toxicity
GOST ISO 10993-4-2011 Medical devices. Biological evaluation of medical devices. Part 4. Selection of tests for interactions with blood
GOST ISO 10993-5-2011 Medical devices. Biological evaluation of medical devices. Part 5. Tests for in vitro cytotoxicity
GOST ISO 10993-6-2011 Medical devices. Biological evaluation of medical devices. Part 6. Tests for local effects after implantation
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST R IEC 60601-1-2-2014 Medical electrical equipment. Part 1-2. General requirements for basic safety and essential performance. Collateral standard. Electromagnetic compatibility. Requirements and tests
GOST R IEC 60601-1-2010 Medical electrical equipment. Part 1. General requirements for basic safety and essential performance
2017GOST R 57506-2017 Medical devices. Implantable defibrillators and other active implantable medical devices intended to treat tachyarrhythmia. Technical requirements for governmental purchases