YY/T 0606.5-2007 Tissue engineered medical Products—Part 5:Characterization and testing of substrates and scaffolds

YY/T 0606.3-2007 Tissue engineered medical products—Part 3:General classification YY/T 0606.4-2007 Tissue engineered medical product—Part 4:Terminology and classification of skin substitute YY/T 0606.9-2007 Tissue engineered medical products—Part 9:Sodium hyaluronate YY/T 0606.12-2007 Tissue engineered medical products—Part 12:Guide for processing cells,tissues,and organs

YY/T 1616-2018 Tissue engineering medical device products—Standard guide for characterization and testing of biomaterial scaffolds

GB/T 528-1998 Rubber,vulcanized or thermoplastic—Determination of tensile stress-strain properties GB/T 1034-1998 Plastics—Determination of water absorption GB/T 1040.1-2006 Plastics—Determination of tensile properties—Part 1:General principles GB/T 1040.2-2006 Plastics—Determination of tensile properties—Part 2:Test conditions for moulding and extrusion plastics GB/T 1040.3-2006 Plastics—Determination of tensile properties—Part 3:Test conditions for films and sheets GB/T 1040.4-2006 Plastics—Determination of tensile properties—Part 4:Test conditions for isotropic and orthotropic fibre-reinforced plastic composites GB/T 1041-1992 GB/T 1630-1989 Epoxide resins—Designation GB/T 1632-1993 Determination of viscosity number and limiting viscosity number of polymers in dilute solution GB/T 1634.1-2004 Plastics—Determination of temperature of deflection under load—Part 1:General test method GB/T 1634.2-2004 Plastics—Determination of temperature of deflection under load—Part 2:Plastics,ebonite and long-fibre-reinforced composites GB/T 2547-1981 Plastic resins—Sampling GB/T 3358.1-1993 Terms for statistics—Part 1:Terms for general statistics GB/T 3358.2-1993 Terms for statistics—Part 2:Terms for statistical quality control GB/T 3358.3-1993 Terms for statistics—Part 3:Terms for experimental design GB/T 3682-2000 Determination of the melt mass-flow rate (MFR) and the melt volume-flow rate (MVR) of thermoplastics GB 4234-2003 Stainless steel for surgical implants GB/T 6379.1-2004 Accuracy(trueness and precision)of measurement methods and results—Part 1:General principles and definitions GB/T 6379.2-2004 Accuracy(trueness and precision)of measurement methods and results—Part 2:Basic method for the determination of repeatability and reproducibility of a standard measurement method GB/T 6425-1986 Nomenclature for thermal analysis GB/T 9341-2000 Plastics—Determination of flexural properties GB/T 11415-1989 Laboratory sintered (fritted) filters—Porosity grading, classification and designation GB/T 12909-1991 Paper and board—Determination of bending stiffness—Resonance method GB/T 13022-1991 Plastics—Determination of tensile properties of films GB/T 13810-1997 Wrought titanium and titanium alloy for surgical implants GB/T 15593-1995 Plasticized polyvinyl chloride (PVC) compounds for transfusion (infusion) equipment GB 16352-1996 Standards for γ-rays radiation sterilization of disposable medical appliances GB/T 16421-1996 Plastics—Determination of tensile properties by use of small specimens GB/T 16886.1-2001 Biological evaluation of medical devices—Part 1:Evaluation and testing GB/T 16886.3-1997 Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicity GB/T 16886.4-2003 Biological evaluation of medical devices—Part 4:Selection of tests for interactions with blood GB/T 16886.5-2003 Biological evaluation of medical devices—Part 5:Test for in vitro cytotoxicity GB/T 16886.6-1997 Biological evaluation of medical devices—Part 6:Tests for local effects after implantation GB/T 16886.9-2001 Biological evaluation of medical devices—Part 9:Framework for identification and quantification of potential degradation products GB/T 16886.10-2005 Biological evaluation of medical devices—Part 10:Tests for irritation and delayed-type hypersensitivity GB/T 16886.11-1997 Biological evaluation of medical devices—Part 11:Tests for systemic toxicity GB/T 16886.12-2005 Biological evaluation of medical devices—Part 12:Sample preparation and reference materials GB/T 16886.13-2001 Biological evaluation of medical devices—Part 13:Identification and quantification of degradation products from polymeric medical devices GB/T 16886.14-2003 Biological evaluation of medical devices—Part 14:Identification and quantification of degradation products from ceramics GB/T 16886.15-2003 Biological eveluation of medical devices—Part 15:Identification and quantification of degradation products from metals and alloys GB/T 16886.16-2003 Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables GB/T 16886.17-2005 Biological evaluation of medical devices—Part 17:Establishment of allowable limits for leachable substances GB 17100-1997 Casting Co-Cr-Mo alloy for surgical implants GB 18278-2000 Sterilization of health care products—Requirements for validation and routine control—Industrial moist heat sterilization GB 18279-2000 Medical devices—Validation and routine control of ethylene oxide sterilization GB 18280-2000 Sterilization of health care products—Requirement for validation and routine control—Radiation sterilization GB 18281.1-2000 Sterilization of health care products—Biological indicators—Part 1:General GB 18281.2-2000 Sterilization of health care products—Biological indicators—Part 2:Biological indicators for ethylene oxide sterilization GB 18281.3-2000 Sterilization of health care products—Biological indicators—Part 3:Biological indicators for moist heat sterilization GB/T 19000-2000 Quality management systems—Fundamentals and vocabulary GB/T 19001-2000 Quality management systems—Requirements GB/T 19466.1-2004 Plastics—Differential scanning calorimetry(DSC)—Part 1:General principles GB/T 19466.2-2004 Plastics—Differential scanning calorimetry(DSC)—Part 2:Determination of glass transition temperature GB/T 19466.3-2004 Plastics—Differential scanning calorimetry(DSC)—Part 3:Determination of temperature and enthalpy of melting and crystallization GB/T 19500-2004 General rules for X-ray photoelectron spectroscopic analysis method GB/T 19633-2005 Packaging for terminally sterilized medical devices YY 0117.2-2005 Implants for surgery—Forgings, castings for bone joint prostheses—ZTi6Al4V titanium alloy castings YY/T 0287-2003 Medical devices—Quality management systems—Requirements for regulatory purposes YY 0303-1998 Hydroxyapatite powder for medical applications YY 0305-1998 Hydroxyapatite Bioceramics YY 0334-2002 General specification for surgical implants made of silicone elastomer YY 0459-2003 Implants for surgery—Acrylic resin cements YY/T 0473-2004 Implants for surgery—Copolymers and blends based on polylactide—In vitro degradation testing YY/T 0474-2004 Poly(L-lactide) resins and fabricated forms for surgical implants—In vitro degradation testing 中华人民共和国药典(2005年版 二部) ISO 844:2004 ISO 6474:1994 ISO 10993.18:2005 EN 12442.1:2000 EN 12442.2:2000 EN 12442.3-2000