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 |
Email:hello@jjrlab.com
Write your message here and send it to us
What is the meaning of EMC?
Why EMC Test Is Required?
What is the Difference Between EMI and EMC?
What is the difference between CE EMC and CE LVD?
What Is the EU WEEE for Electronic and Electrical
What Is the ASTM D4316-95(2016) Hot Water Bottle T
Amazon Electric Massager UL1647 Test Report
What Is IEC 60068-2-5:2018 Solar Radiation Test?
Leave us a message
24-hour online customer service at any time to respond, so that you worry!