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YY/T 0316-2008 Medical devices - Application of risk management to medical devices $620.00 immediately superseded
YY/T 0316-2016 Medical devices-Application of risk management to medical devices $400.00 immediately valid
YY/T 0340-2002 Implants for surgery--Fundamental principles $150.00 via email in 1~3 business day superseded
YY/T 0342-2002 Implants for surgery--Determination of bending strength and stiffness of bone plates $120.00 via email in 1~3 business day superseded
YY/T 0343-2002 Liquid penetrant inspection of metallic surgical implants $100.00 immediately valid
YY/T 0467-2003 Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devices $300.00 via email in 1~3 business day superseded
YY/T 0468-2003 Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange $270.00 via email in 1~3 business day abolished
YY/T 0473-2004 Implants for surgery - Copolymers and blends based on polylactide - $150.00 via email in 1~3 business day valid
YY/T 0474-2004 Poly(L-lactide) resins and fabricated forms for surgical implants - $130.00 via email in 1~3 business day valid
YY/T 0595-2020 Medical devices—Quality management systems—Guidance on the application of YY/T 0287-2017 $1170.00 immediately valid
YY/T 0616-2007 Medical gloves for single use—Requirements and testing for biological evaluation $330.00 via email in 1~5 business day superseded
YY/T 0616.1-2016 Medical gloves for single use―Part 1:Requirements and testing for biological evaluation $140.00 via email in 1~5 business day valid
YY/T 0616.7-2020 Medical gloves for single use—Part 7:Test method for the immunological measurement of antigenic protein $165.00 via email in 1~3 business day valid
YY/T 0618-2007 Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing $345.00 via email in 1~5 business day superseded
YY/T 0618-2017 Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing $495.00 via email in 1~5 business day valid
YY/T 0638-2008 In vitro diagnostic medical devices -Measurement of quantities in biological samples - Metrological traceability of assigned values for catalytic concentration of enzymes in calibrators and control materials $190.00 via email in 1~3 business day valid
YY/T 0639-2008 In Vitro Diagnostic Medical Devices-Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology $190.00 via email in 1~3 business day superseded
YY/T 0639-2019 In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology $280.00 via email in 1~3 business day valid
YY/T 0664-2008 Medical device software - Software life cycle processes $490.00 immediately superseded
YY/T 0664-2020 Medical device software—Software life cycle processes $975.00 via email in 1~10 business day valid
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