China Medical Device GB Standards List

GB standards are the China national standards; Prefix code GB are Mandatory standards, GB/T are Recommended standards; All products or service must be compliance with GB standards; If you want to export products or services to huge Chinese market, need ensure they are meet the requirements of GB china national standards; We provide Chinese GB standards and English version GB standards Lookup, Translate, Download, Imported Commodity GB standards Testing and Compliance review services.

China "Medical Device" GB Standards List:

Standard Code	Standard Title	Standard Class
GB/T 16886.3-2019	Biological evaluation of Medical Devices—Part 3: Tests for genotoxicity, carcinogenicity and reproductive toxicity	Medical Device China National Standards
GB/T 19974-2018	Sterilization of health care products—General requirement for characterization of a sterilization agent and the development,validation and routine control of a sterilization process for Medical Devices	Medical Device China National Standards
GB/T 19973.2-2018	Sterilization of Medical Devices—Microbiological methods—Part 2: Tests of sterility performed in the definition，validation and maintenance of a sterilization process	Medical Device China National Standards
GB/T 16886.10-2017	Biological evaluation of Medical Devices—Part 10: Tests for irritation and skin sensitization	Medical Device China National Standards
GB/T 16886.12-2017	Biological evaluation of Medical Devices—Part 12:Sample preparation and reference materials	Medical Device China National Standards
GB/T 16886.5-2017	Biological evaluation of Medical Devices—Part 5: Tests for in vitro cytotoxicity	Medical Device China National Standards
GB/T 16886.13-2017	Biological evaluation of Medical Devices—Part 13: Identification and quantification of degradation products from polymeric medical devices	Medical Device China National Standards
GB/T 16886.9-2017	Biological evaluation of Medical Devices—Part 9: Framework for identification and quantification of potential degradation products	Medical Device China National Standards
YY/T 0052-1991	(Change the way the Medical Device product design and design documents)	Medical Device China Medicine & Medical Device Standards
YY/T 0051-1991	(The integrity of the Medical Device product design and its main design file)	Medical Device China Medicine & Medical Device Standards
YY/T 0050-1991	(Medical Device product design and design principles File No.)	Medical Device China Medicine & Medical Device Standards
YY/T 0049-1991	(Medical Device product design and design file formats)	Medical Device China Medicine & Medical Device Standards
YY/T 0048-1991	(The basic requirements for Medical Devices work pattern)	Medical Device China Medicine & Medical Device Standards
YY/T 0047-1991	(The term Medical Device product design and design documents)	Medical Device China Medicine & Medical Device Standards
YY/T 0288-1996	Quality system. Medical Devices. Particular requirements for the application of GB/T 19002. ISO 9002	Medical Device China Medicine & Medical Device Standards
YY/T 0287-1996	Quality system—Medical Devices—Particular requirements for the application of GB/T 19001—ISO 9001	Medical Device China Medicine & Medical Device Standards
YY/T 0297-1997	Clinical investigation of Medical Devices	Medical Device China Medicine & Medical Device Standards
YY/T 91051-1999	System table for standard of Medical Devices	Medical Device China Medicine & Medical Device Standards
YY/T 91050-1999	Editorial method for design documents of Medical Device products	Medical Device China Medicine & Medical Device Standards
YY 91055-1999	Paint coating for Medical Devices. Classification and specification	Medical Device China Medicine & Medical Device Standards
YY/T 0316-2000	Medical Devices. Risk management. Part 1: Application of risk analysis	Medical Device China Medicine & Medical Device Standards
YY/T 1000.2-2005	Development of Medical Devices industrial standards. Part 2: Guidance for work	Medical Device China Medicine & Medical Device Standards
YY/T 1000.1-2005	Development of Medical Devices industrial standards. Part 1: Stage division, code and procedure	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY 0033-2000	Good manufacture practice for sterile Medical Devices	Medical Device China Medicine & Medical Device Standards
YY/T 0268-2001	Dentistry--Preclinical evaluation of biocompatibility of Medical Devices used in dentistry--Part 1: Evaluation and test methods selection	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0468-2003	Nomenclature-Specification for a nomenclature system for Medical Devices for the purpose of regulatory data exchange	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0316-2003	Medical Devices-Application of risk management to medical devices	Medical Device China Medicine & Medical Device Standards
YY/T 0287-2003	Medical Devices. Quality management systems. Requirements for regulatory purposes	Medical Device China Medicine & Medical Device Standards
YY 0466-2003	Medical Devices-Symbols to be used with medical device labels, labelling and information to be supplied	Medical Device China Medicine & Medical Device Standards
YY/T 0316-2008	Medical Devices. Application of risk management to medical devices	Medical Device China Medicine & Medical Device Standards
YY/T 0268-2008	Dentistry. Biological evaluation of Medical Devices used in dentistry. Part 1: Evaluation and test	Medical Device China Medicine & Medical Device Standards
YY/T 0127.12-2008	Dentistry. Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Micronucleus test	Medical Device China Medicine & Medical Device Standards
YY/T 0595-2006	Medical Devices. Quality management systems. Guidance on the application of YY/T0287-2003	Medical Device China Medicine & Medical Device Standards
YY/T 0615.2-2007	Requirements for Medical Devices to be designated “STERILE”. Part 2: Requirements for aseptically processed medical devices	Medical Device China Medicine & Medical Device Standards
YY/T 0615.1-2007	Requirements for Medical Devices to be designated “STERILE”. Part 1: Requirements for terminally sterilized medical devices	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0664-2008	Medical Device software. Software life cycle processes	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0771.2-2009	Medical Devices utilizing animal tissues and their derivatives. Part 2: Controls on sourcing, collection and handling	Medical Device China Medicine & Medical Device Standards
YY/T 0771.1-2009	Medical Devices utilizing animal tissues and their derivatives. Part 1: Application of risk management	Medical Device China Medicine & Medical Device Standards
YY/T 0806-2010	Polycarbonate material for manufacture of infusion, transfusion and injection equipments for medical use and other Medical Devices	Medical Device China Medicine & Medical Device Standards
YY/T 0802-2010	Sterilization of Medical Devices. Information to be provided by the manufacturer for the processing of resterilizable medical devices	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0698.4-2009	Packaging materials for terminal sterilized Medical Devices. Part 4: Paper bags. Requirements and test methods	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0698.2-2009	Packaging materials for terminal sterilized Medical Devices. Part 2: Sterilization wrap. Requirements and test methods	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0681.1-2009	Test methods for sterile Medical Device package. Part 1: Test guide for accelerated aging	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0127.4-2009	Biological evaluation of Medical Devices used in dentistry - Part 2: Test method - Bone implant test	Medical Device China Medicine & Medical Device Standards
YY/T 0127.2-2009	Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Acute systemic toxicity:intravenous path	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0127.14-2009	Biological evaluation of Medical Devices used in dentistry. Part 2: Test method. Acute oral toxicity test	Medical Device China Medicine & Medical Device Standards
YY/T 0127.13-2009	Biological evaluation of Medical Devices used in dentistry. Part 2: Tset method. Oral mucous membrane irritation test	Medical Device China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
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 China Medicine & Medical Device Standards
YY/T 0681.3-2010	Test methods for sterile Medical Device package. Part 3: Internal pressurization failure resistance of unrestrained packages	Medical Device China Medicine & Medical Device Standards
YY/T 0681.2-2010	Test methods for sterile Medical Device package. Part 2: Seal strength of flexible battier materials	Medical Device China Medicine & Medical Device Standards
YY/T 0698.1-2011	Packaging materials for terminal sterilized Medical Devices. Part 1: Co-extrusion plastic films used for vacuum forming packaging. Requirements and test methods	Medical Device China Medicine & Medical Device Standards
YY/T 0681.9-2011	Test methods for sterile Medical Device package. Part 9: Burst testing of flexible package seals using internal air pressurization weight restraining plates	Medical Device China Medicine & Medical Device Standards
YY/T 0681.8-2011	Test methods for sterile Medical Device package. Part 8: Coating/adhesive weight determination	Medical Device China Medicine & Medical Device Standards
YY/T 0681.7-2011	Test methods for sterile Medical Device package. Part 7: Evaluating inks or coating adhesion to flexible packaging materials using tape	Medical Device China Medicine & Medical Device Standards
YY/T 0681.6-2011	Test methods for sterile Medical Device package. Part 6: Evaluation of chemical resistance of printed inks and coatings on flexible packaging materials	Medical Device China Medicine & Medical Device Standards
YY/T 0681.10-2011	Test methods for sterile Medical Device package. Part 10: Test for microbial barrier ranking of porous package material	Medical Device China Medicine & Medical Device Standards
YY/T 0879.1-2013	Test for sensitization of Medical Devices. Part 1: Murine local lymph node assay(LINA):Radioisotope incorporation method	Medical Device China Medicine & Medical Device Standards
YY/T 0878.1-2013	Test for complement activation of Medical Devices. Part:Serum whole complement activation	Medical Device China Medicine & Medical Device Standards
YY/T 0870.3-2013	Test for genotoxicity of Medical Devices. Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells	Medical Device China Medicine & Medical Device Standards
YY/T 0870.2-2013	Test for genotoxicity of Medical Devices. Part 2: In vitro mammalian chromosome aberration test	Medical Device China Medicine & Medical Device Standards
YY/T 0870.1-2013	Test for genotoxicity of Medical Devices. Part 1: Bacterial reverse mutation test	Medical Device China Medicine & Medical Device Standards
YY/T 0869-2013	Medical Devices. Coding structure for adverse event type and cause	Medical Device China Medicine & Medical Device Standards
YY 0970-2013	Sterilization of single- use Medical Devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants	Medical Device China Medicine & Medical Device Standards
YY/T 0993-2015	Biological evaluation of Medical Devices. Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)	Medical Device China Medicine & Medical Device Standards
YY/T 0879.2-2015	Test for hypersensitivity of Medical Devices. Part 2:Marine Local Lymph Node Assay (LLNA): BrdU-ELISA method	Medical Device China Medicine & Medical Device Standards
YY/T 0878.2-2015	Test for complement activation of Medical Devices. Part 2: Serum alternative pathway complement activation	Medical Device China Medicine & Medical Device Standards
YY/T 0771.4-2015	Medical Devices utilizing animal tissues and their derivatives. Part 4:Principles for elimination and/or inactivation of transmissible spongiform encephalopathy agents and validation assays for those processes	Medical Device China Medicine & Medical Device Standards
YY/T 0468-2015	Medical Devices. Quality management. Medical device nomenclature data structure	Medical Device China Medicine & Medical Device Standards
YY/T 0466.2-2015	Medical Devices. Symbols to be used with medical device labels, labelling, and information to be supplied. Part 2: Symbol development, selection and validation	Medical Device China Medicine & Medical Device Standards
YY/T 0927-2014	Guidance of determination for di(2-ethylhexyl)phthalate (DEHP) released from PVC Medical Devices	Medical Device China Medicine & Medical Device Standards
YY/T 0926-2014	Quantitative analysis of DEHP in PVC Medical Devices	Medical Device China Medicine & Medical Device Standards
YY/T 0870.5-2014	Test for genotoxicity of Medical Devices. Part 5: Mammalian bone marrow chromosome aberration test	Medical Device China Medicine & Medical Device Standards
YY/T 0870.4-2014	Test for genotoxicity of Medical Devices. Part 4:Mammalian bone marrow erythocyte micronucleus test	Medical Device China Medicine & Medical Device Standards
YY/T 0681.13-2014	Test methods for sterile Medical Device package. Part 13: Slow rate penetration resistance of flexible barrier films and laminates	Medical Device China Medicine & Medical Device Standards
YY/T 0681.12-2014	Test methods for sterile Medical Device package. Part 12: Flex durability of flexible barrier films	Medical Device China Medicine & Medical Device Standards
YY/T 0681.11-2014	Test methods for sterile Medical Device package. Part 11: Determining integrity of seals for medical packaging by visual inspection	Medical Device China Medicine & Medical Device Standards
YY/T 0127.5-2014	Biological evaluation of Medical Devices used in dentistry. Part 5: Inhalation toxicity test	Medical Device China Medicine & Medical Device Standards
YY/T 0127.3-2014	Biological evaluation of Medical Devices used in dentistry-Part 3: Endodontic usage test	Medical Device China Medicine & Medical Device Standards
YY/T 0127.17-2014	Biological evaluation of Medical Devices used in dentistry. Part 17: Mouse lymphoma cells (TK) gene mutation test	Medical Device China Medicine & Medical Device Standards
YY/T 0127.11-2014	Biological evaluation of Medical Devices used in dentistry. Part 11: Pulp capping test	Medical Device China Medicine & Medical Device Standards

Find out:182Items | To Page of: First -Previous-Next -Last | 1 2

- Since 2001 -
Focus on China Standards & Compliance Services

www.rjs.cn
China Licenses

www.transcustoms.com
China HS code & Tariff

www.gbstandards.org
China National Standards