Code of China Chinese Standard Classification Professional Classification ICS Classification Latest
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Standard No. Title Price(USD) Delivery Status Add to Cart
YY/T 1292.3-2016 Test for reproductive/developmental toxicity of medical devices—Part 3:One-generation reproductive toxicity test $154.00 via email in 1~3 business day valid
YY/T 1292.4-2017 Test for reproductive and developmental toxicity of medical devices- Part 4:Two-generation reproductive toxicity test $195.00 via email in 1~3 business day valid
YY/T 1406.1-2016 Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software $690.00 via email in 1~5 business day valid
YY/T 1437-2016 Medical devices—Guidance on the applicantion of ISO 14971 $220.00 via email in 1~3 business day superseded
YY/T 1437-2023 Medical devices-Guidance on the application of GB/T 42062 $1125.00 via email in 1~5 business day valid
YY/T 1465.1-2016 Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro $110.00 via email in 1~3 business day valid
YY/T 1465.2-2016 Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay) $110.00 via email in 1~3 business day valid
YY/T 1473-2023 Guide for standardization for medical devices―Inclusion of safety aspects in the development of standards $375.00 via email in 1~5 business day valid
YY/T 1512-2017 Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process $140.00 via email in 1~3 business day valid
YY/T 1630-2018 Fundamental requirements for unique device identifier $120.00 immediately valid
YY/T 1649.1-2019 Test method for interactions of medical devices with platelet—Part 1:In vitro platelet count assay $105.00 via email in 1~3 business day valid
YY/T 1649.2-2019 Test method for interactions of medical devices with platelet — Part2 : In vitro platelet activation products ( β -TG, PF4 and TxB2 ) assay $140.00 via email in 1~5 business day valid
YY/T 1651.1-2019 Tests for hemolysis of medical devices—Part 1:Material induced hemolysis assay $165.00 via email in 1~3 business day valid
YY/T 1670.1-2019 Evaluation of neurotoxicity of medical devices―Part 1:Standard guide for selecting tests to evaluate potential neurotoxicity $105.00 via email in 1~3 business day valid
YY/T 1681-2019 Basic terms of unique device identification system $120.00 via email in 1~3 business day valid
YY/T 1754.1-2020 Preclinical animal study of medical devices—Part 1:General considerations $180.00 immediately valid
YY/T 1754.3-2023 Preclinical Animal Studies of Medical Devices Part 3: An Animal Incisional Hernia Model for Evaluation of Mesh Histological Response and Biomechanical Properties $240.00 via email in 1~3 business day valid
YY/T 1759-2020 Guide for design and evaluation of primary flexible packaging for medical devices $405.00 via email in 1~5 business day valid
YY/T 1770.1-2021 Test method for thrombogenicity study—Part 1:Thrombogenicity study in dogs in vivo $150.00 via email in 1~3 business day valid
YY/T 1775.1-2021 Biological evaluation of absorbable medical devices—Part 1:Guidance for absorbable implants $160.00 via email in 1~3 business day valid
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