What are the biocompatibility testing standards?
Project Name | Testing standards | Cycle (week) |
Sensitization test (extraction with 0.9% sodium chloride injection) | ISO 10993-10:2010, GB/T 16886.10-2017 | 5 |
Allergy test (sesame oil extraction) | ISO 10993-10:2010, GB/T 16886.10-2017 | 5 |
Sensitization test (single-sided closed patch method, smear or patch) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Skin and intradermal irritation test (extraction with 0.9% sodium chloride injection) | ISO 10993-10:2010, GB/T 16886.10-2017 | 2 |
Skin and intradermal irritation test (sesame oil extraction) | ISO 10993-10:2010, GB/T 16886.10-2017 | 2 |
Intradermal irritation test (direct use) | ISO 10993-10:2010, GB/T 16886.10-2017 | 2 |
Skin irritation test (direct application method, smear or application) | ISO 10993-10:2010, GB/T 16886.10-2017 | 2 |
Skin irritation test (double-sided patch method) | ISO 10993-10:2010, GB/T 16886.10-2017 | 2 |
Acute toxicity test (sesame oil extraction) | ISO10993-11:2017, GB/T 16886.11-2011, | 3 |
Acute toxicity test (extraction with 0.9% sodium chloride injection) | ISO10993-11:2017, GB/T 16886.11-2011, | 3 |
Pyrogen test | ISO10993-11:2017, EN ISO 10993-11:2018 | 4 |
Pyrogen test | GB/T 16886.11-2011, GB/T 16886.11-2021, GB/T 14233.2-2005, Chinese Pharmacopoeia 2020 Edition Part IV | 4 |
Subacute systemic toxicity test (subcutaneous, intramuscular implantation, 28 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 6 |
Subacute systemic toxicity study (intravenous injection, 14 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 3 |
Subacute systemic toxicity test (intraperitoneal injection, 28 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 5 |
Subacute systemic toxicity test Bipolar (14 days intravenous injection, 28 days intraperitoneal injection) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 6 |
Subacute systemic toxicity test (oral administration, 0.9% sodium chloride injection extraction, 28 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 6 |
Subacute systemic toxicity test (oral administration, sesame oil extraction, 28 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 6 |
Subacute systemic toxicity test (oral administration, bipolar, 28 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 6 |
Subchronic systemic toxicity test (subcutaneous implantation, 90 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 18 |
Subchronic systemic toxicity test (intravenous injection, 0.9% sodium chloride injection extraction, 28 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 9 |
Subchronic systemic toxicity test (intraperitoneal injection, 0.9% sodium chloride injection extraction, 90 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 18 |
Subchronic systemic toxicity test (double injection, 14 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 7 |
Subchronic systemic toxicity test (bipolar, 28 days tail vein, 90 days intraperitoneal) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 18 |
Subchronic systemic toxicity test (oral administration, 0.9% sodium chloride injection extraction, 90 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 18 |
Subchronic systemic toxicity test (oral administration, sesame oil extraction, 90 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 18 |
Subchronic systemic toxicity test (oral administration, bipolar) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 18 |
Subchronic systemic toxicity study (bone implantation, 90 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 18 |
Subchronic systemic toxicity test (muscle implantation, 90 days) | ISO10993-11:2017, GB/T 16886.11-2011, GB/T 16886.11-2021 | 18 |
Slow poison (muscle implant, 6 months) | ISO 10993-11:2017, EN ISO 10993-11:2018, GB/T 16886.11-2021 | 34 |
Slow poison (subcutaneous implant, 6 months) | ISO 10993-11:2017, EN ISO 10993-11:2018, GB/T 16886.11-2021 | 34 |
Slow poisoning (bone implantation, 6 months) | ISO 10993-11:2017, EN ISO 10993-11:2018, GB/T 16886.11-2021 | 34 |
Slow poison (1 year) | ISO 10993-11:2017, EN ISO 10993-11:2018, GB/T 16886.11-2021 | 60 |
Carcinogenicity (1 year) | ISO 10993-11:2017, EN ISO 10993-11:2018, GB/T 16886.11-2021 | 62 |
Oral irritation (extracted with 0.9% sodium chloride injection) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Oral irritation (sesame oil extract) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Vaginal irritation (extracted with 0.9% sodium chloride injection) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Vaginal irritation (sesame oil extract) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Penile stimulation (extracted with 0.9% sodium chloride injection) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Penis stimulation (sesame oil extract) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Eye irritation (extracted with 0.9% sodium chloride injection) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Eye irritation (sesame oil extract) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Rectal irritation (extracted with 0.9% sodium chloride injection) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Rectal irritation (sesame oil extract) | ISO 10993-10:2010, GB/T 16886.10-2017 | 6 |
Muscle implantation trial (1 week) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 6 |
Muscle implantation trial (2 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 7 |
Muscle implantation trial (4 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 9 |
Muscle implant trial (13 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 18 |
Muscle implant trial (26 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 31 |
Muscle implantation test (two cycles) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | Add any two cycles above |
Muscle implantation test (three cycles) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | Add any three cycles above |
Brain implant trial (1 week) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 8 |
Brain implant trial (2 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 9 |
Brain implant trial (4 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 11 |
Brain implant trial (13 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 20 |
Brain implant trial (26 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 33 |
Brain implant trial (two cycles) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | Add any two cycles above |
Brain implant trial (three cycles) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | Add any three cycles above |
Subcutaneous implantation test (1 week) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 6 |
Subcutaneous implantation test (2 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 7 |
Subcutaneous implantation test (4 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 9 |
Subcutaneous implantation trial (13 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 18 |
Subcutaneous implantation trial (26 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 31 |
Subcutaneous implantation trial (52 weeks) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | 57 |
Subcutaneous implantation test (two cycles) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | Add any two cycles above |
Subcutaneous implantation test (three cycles) | ISO 10993-6:2016, GB/T 16886.6-2015, EN ISO 10993-6:2016, GB/T 16886.6-2022 | Add any three cycles above |
In vivo micronucleus test (extraction with 0.9% sodium chloride injection) | ISO 10993-3:2014, GB/T 16886.3-2019, EN ISO 10993-3:2014, ISO/TR 10993-33:2015(E), YY/T 0870.4-2014, YY/T 0127.12-2008 | 5 |
In vivo micronucleus test (sesame oil extraction) | ISO 10993-3:2014, GB/T 16886.3-2019, EN ISO 10993-3:2014, ISO/TR 10993-33:2015(E), YY/T 0870.4-2014, YY/T 0127.12-2008 | 5 |
Thrombosis test (in vivo test) Add Beagle cost 4000 | ISO 10993-4:2017, GB/T 16886.4-2003, EN ISO 10993-4:2017, GB/T 16886.4-2022 | 3 |
USP88 (Acute toxicity, intradermal, subcutaneous implantation in rats) | USP 43 <88> | 3 |
USP88 (acute toxicity, intradermal, rabbit muscle implant) | USP 43 <88> | 3 |
USP88 (acute toxicity, intradermal, rabbit muscle implantation, rat subcutaneous implantation) | USP 43 <88> | 3 |
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