Standard Code |
Standard Title |
Standard Class |
Order |
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 |
|