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China Medical Device Standards,GB standards,english version translation, price,purchase,download
China Medical Device GB Standards Search System
China "Medical Device" GB Standards List:
SN/T 3062.2-2011 Packaging materials for terminally sterilized Medical Devices for import. Part 2: Paper bags. Requirements and test methods Medical Device
SN/T 3062.4-2011 Packaging materials for terminally sterilized Medical Devices for import. Part 4: Requirements for materials and sterile barrier systems of importing medical device sterilization packaging Medical Device
SN/T 3062.1-2011 Packing materials for terminally sterilized Medical Devices for import. Part 1: Validation requirements for forming,sealing and assembly processes Medical Device
SN/T 3061-2011 Rules of the inspection of packaging for import terminally sterilized Medical Devices Medical Device
GB/T 16886.1-2011 Biological evaluation of Medical Devices - Part 1: Evaluation and testing within a risk management process Medical Device
YY/T 0681.2-2010 Test methods for sterile Medical Device package. Part 2: Seal strength of flexible battier materials Medical Device
YY/T 0802-2010 Sterilization of Medical Devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices Medical Device
YY/T 0681.5-2010 Test methods for sterile Medical Device package. Part 5: Detecting gross leaks in medical packaging by internal pressurization (bubble test) Medical Device
YY/T 0681.3-2010 Test methods for sterile Medical Device package. Part 3: Internal pressurization failure resistance of unrestrained packages Medical Device
YY/T 0590.2-2010 Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1-2:Determination of the detective quantum efficiency. Detectors used in mammography Medical Device
YY/T 0681.4-2010 Test methods for sterile Medical Device package. Part 4: Detecting seal leaks in porous packages by dye penetration Medical Device
YY/T 0806-2010 Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other Medical Devices Medical Device
YY/T 0127.15-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Subacute and subchronic systemic toxicity test:oral route Medical Device
YY/T 0127.9-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Cytotoxicity tests:Agar diffusion test and filter diffusion test Medical Device
YY/T 0127.16-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. In Vitro mammalian chromosome aberration test Medical Device
YY/T 0771.1-2009 Medical Devices utilizing animal tissues and their derivatives. Part 1: Application of risk management Medical Device
YY/T 0127.4-2009 Biological evaluation of Medical Devices used in dentistry - Part 2: Test method - Bone implant test Medical Device
YY/T 0771.3-2009 Medical Devices utilizing animal tissues and their derivatives. Part 3: Validation of the elimination and/or inactivation of viruses and Transmissible Spongiform Encephalopathy (TSE) agents Medical Device
YY/T 0771.2-2009 Medical Devices utilizing animal tissues and their derivatives. Part 2: Controls on sourcing, collection and handling Medical Device
YY/T 0466.1-2009 Medical Devices. Symbols to be used with medical device labels, labelling and information to be supplied. Part 1: General requirements Medical Device
GB 24627-2009 Standard specification for wrought nickel-titanium shape memory alloys for Medical Devices and surgical implants Medical Device
YY/T 0698.9-2009 Packaging materials for terminally sterilized Medical Devices. Part 9: Uncoated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. Requirements and test methods Medical Device
YY/T 0698.10-2009 Packaging materials for terminally sterilized Medical Devices. Part 10: Adhesive coated nonwoven materials of polyolefines for use in the manufacture of sealable pouches, reels and lids. Requirements and test methods Medical Device
YY/T 0698.3-2009 Packaging materials for terminal sterilized Medical Devices. Part 3: Paper for use in the manufacture of paper bags (specified in YY/T 0698.4) and in the manufacture of pouches and reels (specified in YY/T 0698.5). Requirements and test methods Medical Device
YY/T 0127.13-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Tset method. Oral mucous membrane irritation test Medical Device
YY/T 0127.10-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Salmonella typhimurium reverse mutation assay (Ames mutagenicity test) Medical Device
YY/T 0698.6-2009 Packaging materials for terminal sterilized Medical Devices. Part 6: Paper for manufacture of sterile barrier systems intended for sterilization by low temperature sterilization processes or irradiation. Requirements and test methods Medical Device
YY/T 0698.8-2009 Packaging materials for terminally sterilized Medical Devices. Part 8: Re-usable sterilization containers for team sterilizers. Requirements and test methods Medical Device
YY/T 0698.2-2009 Packaging materials for terminal sterilized Medical Devices. Part 2: Sterilization wrap. Requirements and test methods Medical Device
YY/T 0698.7-2009 Packaging materials for terminal sterilized Medical Devices. Part 7: Adhesive coated paper for the manufacture of sealable packs for medical use for sterilization by ethylene oxide or irradiation. Requirements and test methods Medical Device
YY/T 0698.4-2009 Packaging materials for terminal sterilized Medical Devices. Part 4: Paper bags. Requirements and test methods Medical Device
YY/T 0698.5-2009 Packaging materials for terminal sterilized Medical Devices. Part 5: Heat and self-sealable pouches and reels of paper and plastic film construction. Requirements and test methods Medical Device
YY/T 0202-2009 Specifications for medical diagnostic X-ray device for tomography Medical Device
YY/T 0127.2-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Acute systemic toxicity:intravenous path Medical Device
YY/T 0506.6-2009 Surigical drapes, gowns and clean air suits, used as Medical Devices, for patients, clinical staff and equipment. Part 6: Test method to determine the resistance to wet bacterial penetration Medical Device
YY/T 0681.1-2009 Test methods for sterile Medical Device package. Part 1: Test guide for accelerated aging Medical Device
YY/T 0127.14-2009 Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Acute oral toxicity test Medical Device
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 Medical Device
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 Medical Device
YY/T 0316-2008 Medical Devices. Application of risk management to medical devices Medical Device
YY/T 0664-2008 Medical Device software. Software life cycle processes Medical Device
YY/T 0606.10-2008 Tissue engineered medical product. Part 10: In vivo assessment of implantable devices intended to repair or regenerate articular cartilage Medical Device
YY/T 0127.12-2008 Dentistry. Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Micronucleus test Medical Device
YY/T 0639-2008 In Vitro Diagnostic Medical Devices. Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology Medical Device
YY/T 0268-2008 Dentistry. Biological evaluation of Medical Devices used in dentistry. Part 1: Evaluation and test Medical Device
GB/T 16886.3-2008 Biological evaluation of Medical Devices - Part 3: Tests for genotoxicity,carcinogenicity and reproductive toxicity Medical Device
GB/T 21415-2008 In vitro diagnostic Medical Devices - Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials Medical Device
YY/T 0615.2-2007 Requirements for Medical Devices to be designated “STERILE”. Part 2: Requirements for aseptically processed medical devices Medical Device
YY/T 0615.1-2007 Requirements for Medical Devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices Medical Device
YY 0600.1-2007 Lung ventilators for medical use. Particular requirements for basic safety and essential performance. Part 1: Home-care ventilatory support devices Medical Device
YY/T 0595-2006 Medical Devices. Quality management systems. Guidance on the application of YY/T0287-2003 Medical Device
YY/T 0590.1-2005 Medical electrical equipment. Characteristics of digital X-ray imaging devices. Part 1: Determination of the detective quantum efficiency Medical Device
GB/T 19974-2005 Sterilization of health care products -- General requirement for characterization of a sterilizing agent and the development ,validation and routine control of a sterilization process for Medical Devices Medical Device
GB/T 19973.1-2005 Sterilization of Medical Devices -- Microbiological methods -- Part 1: Estimation of population of microorganisms on products Medical Device
GB/T 19973.2-2005 Sterilization of Medical Devices -- Microbiological methods -- Part 2: Test of sterility performed in the validation of a sterilization process Medical Device
GB/T 16886.17-2005 Biological evaluation of Medical Devices -- Part 17: Establishment of allowable limits for leachable substances Medical Device
GB 19212.16-2005 Safety of power transformers ,power supply units and similar devices -- Part 16: Particular requirements for isolating transformers for the supply of medical locations Medical Device
YY/T 1000.2-2005 Development of Medical Devices industrial standards. Part 2: Guidance for work Medical Device
YY/T 1000.1-2005 Development of Medical Devices industrial standards. Part 1: Stage division, code and procedure Medical Device
YY 0568-2005 Medical electrical devices Part 2: Requirements of safety use and special purpose use for head lamps for operational use and for diagnose Medical Device
GB/T 16886.10-2005 Biological evaluation of Medical Devices-Part 10:Tests for irritation and delayed-type hypersensitivity Medical Device
GB/T 19702-2005 In vitro diagnostic Medical Devices-Measurement of quantities in samples of biological origin-Presentation of reference measurement procedures Medical Device
GB/T 19703-2005 In vitro diagnostic Medical Devices-Measurement of quantities in samples of biological origin-Description of reference materials Medical Device
GB/T 16886.12-2005 Biological evaluation of Medical Devices-Part 12:Sample preparation and reference materials Medical Device
GB 9706.24-2005 Medical electrical equipment-Part2-45:Particular requirements for the safety of mammographic X-ray equipment and mammographic sterotactic devices Medical Device
GB/T 19633-2005 Packaging for terminally sterilized Medical Devices Medical Device
YY/T 0202-2004 Medical diagnostic X-ray device for tomography Medical Device
YY/T 0128-2004 Protective devices against diagnostic medical X-radiation. Device and tool Medical Device
YY/T 0287-2003 Medical Devices. Quality management systems. Requirements for regulatory purposes Medical Device
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 Medical Device
YY 0466-2003 Medical Devices-Symbols to be used with medical device labels, labelling and information to be supplied Medical Device
YY/T 0468-2003 Nomenclature-Specification for a nomenclature system for Medical Devices for the purpose of regulatory data exchange Medical Device
YY/T 0316-2003 Medical Devices-Application of risk management to medical devices Medical Device
GB/T 16886.4-2003 Biological evaluation of Medical Devices--Part 4:Selection of tests for interactions with blood Medical Device
GB/T 16886.15-2003 Biological evaluation of Medical Devices--Part 15:Identification and quantification of degradation products from metals and alloys Medical Device
GB/T 16886.14-2003 Biological evaluation of Medical Devices--Part 14:Identification and quantification of degradation products from ceramics Medical Device
GB/T 16886.5-2003 Biological evaluation ofMedical Devices--Part 5: Test for in vitro cytotoxicity Medical Device
YY/T 0268-2001 Dentistry--Preclinical evaluation of biocompatibility of Medical Devices used in dentistry--Part 1: Evaluation and test methods selection Medical Device
YY/T 0127.11-2001 Dentistry--Preclinical evaluation of biocompatibility of Medical Devices used in dentistry--Part 2: Biological evaluation test method of dental materials--Pulp capping test Medical Device
GB/T 16886.9-2001 Biological evaluation of Medical Devices--Part 9:Framework for identification and quantification of potential degradation product Medical Device
GB/T 16886.13-2001 Biological evaluation of Medical Devices--Part 13:Identification and quantification of degradation products from polymeric medical devices Medical Device
GB/T 16886.7-2001 Biological evaluation of Medical Devices--Part 7:Ethylene oxide sterilization residuals Medical Device
GB 18457-2001 Stainless steel needle tubing for manufactureof Medical Devices Medical Device
GB 18279-2000 Medical Devices--Validation androutine control of ethylene oxide sterilization Medical Device
YY 0033-2000 Good manufacture practice for sterile Medical Devices Medical Device
GB/T 17006.5-2000 Evaluation and routine testing in medical imaging departments--Part 2-5:Constancytests--Image display devices Medical Device
YY 0318-2000 Protective device against diagnostic medical X-radiation. Part 3: Protective clothing and protective devices for gonads Medical Device
YY/T 0316-2000 Medical Devices. Risk management. Part 1: Application of risk analysis Medical Device
YY/T 91051-1999 System table for standard of Medical Devices Medical Device
YY 91055-1999 Paint coating for Medical Devices. Classification and specification Medical Device
YY/T 0297-1997 Clinical investigation of Medical Devices Medical Device
YY 0292.2-1997 Protective devices against diagnostic medical X-radiation. Part 2: Protective glass plates Medical Device
YY 0292.1-1997 Protective devices against diagnostic medical X-radiation. Part 1: Determination of attenuation properties of materials Medical Device
GB/T 16886.6-1997 Biological evaluation of Medical Devices--Part 6:Tests for local effects after implantation Medical Device
YY/T 0288-1996 Quality system. Medical Devices. Particular requirements for the application of GB/T 19002. ISO 9002 Medical Device
YY/T 0287-1996 Quality system—Medical Devices—Particular requirements for the application of GB/T 19001—ISO 9001 Medical Device
YY/T 0202-1995 (Medical X-ray tomography device) Medical Device
YY/T 0052-1991 (Change the way the Medical Device product design and design documents) Medical Device
YY/T 0049-1991 (Medical Device product design and design file formats) Medical Device
YY/T 0047-1991 (The term Medical Device product design and design documents) Medical Device
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