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Standard No. Title Price(USD) Delivery Status Add to Cart
GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1: Evaluation and testing within a risk management process $585.00 immediately valid
GB/T 16886.10-2017 Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization $800.00 immediately to be superseded
GB/T 16886.12-2017 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials $140.00 immediately abolished
GB/T 16886.12-2023 Biological evaluation of medical devices—Part 12: Sample preparation and reference materials $315.00 immediately valid
GB/T 16886.13-2017 Biological evaluation of medical devices-Part 13:Identification and quantification of degradation products from polymeric medical devices $140.00 via email in 1~3 business day valid
GB/T 16886.15-2022 Biological evaluation of medical devices—Part 15: Identification and quantification of degradation products from metals and alloys $255.00 via email in 1~3 business day valid
GB/T 16886.16-2021 Biological evaluation of medical devices—Part 16: Toxicokinetic study design for degradation products and leachables $255.00 via email in 1~3 business day valid
GB/T 16886.18-2022 Biological evaluation of medical devices—Part 18: Chemical characterization of medical device materials within a risk management process $285.00 via email in 1~3 business day valid
GB/T 16886.19-2022 Biological evaluation of medical devices—Part 19: Physico-chemical, morphological and topographical characterization of materials $285.00 via email in 1~3 business day valid
GB/T 16886.23-2023 Biological evaluation of medical devices—Part 23: Tests for irritation $990.00 via email in 1~5 business day valid
GB/T 16886.5-2017 Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity $450.00 immediately valid
GB/T 16886.6-2022 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation $435.00 immediately valid
GB/T 16886.9-2017 Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products $140.00 via email in 1~3 business day superseded
GB/T 16886.9-2022 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products $225.00 immediately valid
GB/Z 16886.22-2022 Biological evaluation of medical devices—Part 22:Guidance on nanomaterials $750.00 via email in 1~5 business day valid
YY/T 0690-2008 Clinical laboratory testing and in vitro medical devices—Requirements for in vitro monitoring systems for self-testing of oral anticoagulant therapy $690.00 via email in 1~5 business day valid
YY/T 0771.1-2020 Medical devices utilizing animal tissues and their derivatives—Part 1:Application of risk management $375.00 immediately to be abolished
YY/T 0771.2-2020 Medical devices utilizing animal tissues and their derivatives—Part 2:Controls on sourcing,collection and handling $255.00 immediately valid
YY/T 0771.4-2015 Medical devices utilizing animal tissues and their derivatives―Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes $250.00 via email in 1~3 business day valid
YY/T 1465.7-2021 Immunogenic evaluation method of medical devices—Part 7:Liquid phase multiplex protein quantification technique by flow cytometry $120.00 via email in 1~3 business day valid
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