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 10993-12-2015 Medical devices. Biological evaluation of medical devices. Part 12. Sample preparation and reference materials
GOST ISO 10993-13-2011 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-13-2016 Medical devices. Biological evaluation of medical devices. Part 13. Identification and quantification of degradation products from polymeric medical devices
GOST ISO 10993-14-2011 Medical devices. Biological evaluation of medical devices. Part 14. Identification and quantification of degradation products from ceramics
GOST ISO 10993-15-2011 Medical devices. Biological evaluation of medical devices. Part 15. Identification and quantification of degradation products from metals and alloys
GOST ISO 10993-16-2011 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
GOST ISO 10993-16-2016 Medical devices. Biological evaluation of medical devices. Part 16. Toxicokinetic study design for degradation products and leachables
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 10993-7-2011 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-7-2016 Medical devices. Biological evaluation of medical devices. Part 7. Ethylene oxide sterilization residuals
GOST ISO 10993-9-2015 Medical devices. Biological evaluation of medical devices. Part 9. Framework for identification and quantification of potential degradation products
GOST ISO 14971-2011 Medical devices. Application of risk management to medical devices
GOST R 52501-2005 Water for analytical laboratory use. Specifications
GOST R ISO 22442-1-2011 Medical devices utilizing animal tissues and their derivatives. Part 1. Application of risk management
GOST R ISO 22442-2-2011 Medical devices utilizing animal tissues and their derivatives. Part 2. Controls on sourcing, collection and handling
GOST R ISO 22442-3-2011 Medical devices utilizing animal tissues and their derivatives. Part 3. Validation of the elimination and/or inactivation of viruses and transmissible spongiform encephalopathy agents
GOST R 52770-2016 history
1970GOST R 52770-2020 Medical devices. Evaluation system of biological effects. Part 1. General requirements for biological safety
2016GOST R 52770-2016 Medical devices. Safety requirements. Methods of sanitation-chemical and toxicological tests
2007GOST R 52770-2007 Medical products. Safety requirements. Methods of sanitation-chemical and toxicological tests