YY/T 1557-2017 Thermoplastic polyurethane(TPU) materials for manufacture of infusion,transfusion and injection equipments for medical use

GB/T 528-2009 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties GB/T 529-2008 Rubber,vulcanized or thermoplastic—Determination of tear strength(Trouser,angle and crescent test pieces) GB/T 1040.1-2006 Plastics—Determination of tensile properties—Part 1:General principles GB/T 2411-2008 Plastics and ebonite—Determination of indentation hardness by means of a durometer(shore hardness) GB/T 2918-1998 Plastics—Standard atmospheres for conditioning and testing GB/T 3398.2-2008 Plastics—Determination of hardness—Part 2:Rockwell hardness GB/T 6682-2008 Water for analytical laboratory use—Specification and test methods GB/T 9352-2008 Plastic—Compression moulding of test specimens of thermoplastic materials GB/T 14233.1-2008 Test methods for infusion,transfusion,injection equipments for medical use—Part 1:Chemical analysis methods GB/T 17037.1-1997 Injection moulding of test specimens of thermoplastic materials—Part 1:General principles and moulding of multipurpose and bar test specimens 中华人民共和国药典(2015版四部) GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.1-2011 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process GB/T 16886.1-2022 Biological evaluation of medical devices—Part 1:Evaluation and testing within a risk management process