|
Std ID |
Description (Standard Title) |
Detail |
|
YY/T 1555.2-2018
|
Particular requirements for the silicone gel filled breast implant - Performance requirement of silicone gel filler - Part 2: Limits requirement for extractable substances
|
YY/T 1555.2-2018
|
|
YY/T 1611-2018
|
Human immunodeficiency virus antibodies detection kits (Immuno-chromatography)
|
YY/T 1611-2018
|
|
YY/T 1630-2018
|
Fundamental requirements for unique device identifier
|
YY/T 1630-2018
|
|
YY/T 1643-2018
|
Functional and compatibility test methods for remote medical imaging equipment
|
YY/T 1643-2018
|
|
YY/T 0287-2017
|
Medical devices -- Quality management systems -- Requirements for regulatory purposes
|
YY/T 0287-2017
|
|
YY/T 0618-2017
|
Test methods for bacterial endotoxins of medical devices - Routine monitoring and alternatives to batch testing
|
YY/T 0618-2017
|
|
YY/T 1292.4-2017
|
Test for Reproductive and Developmental Toxicity of Medical Devices - Part 4: Two-generation Reproductive Toxicity Test
|
YY/T 1292.4-2017
|
|
YY/T 1465.4-2017
|
Immunogenic evaluation method of medical devices - Part 4: Phagocytosis of mouse peritoneal macrophages on chicken erythrocytes - Ex-vivo method
|
YY/T 1465.4-2017
|
|
YY/T 1512-2017
|
Biological evaluation of medical devices - Guidance on the conduct of biological evaluation within a risk management process
|
YY/T 1512-2017
|
|
YY/T 1532-2017
|
Biological evaluation of medical devices - Nanomaterials - Hemolysis test
|
YY/T 1532-2017
|
|
YY/T 1535-2017
|
Medical devices for human in vitro assisted reproductive technology - Biological evaluation - Human sperm survival assay
|
YY/T 1535-2017
|
|
YY/T 1555.1-2017
|
Particular requirement of silicone gel filled breast implant—Performance requirement of silicone gel filler—Part 1: Limitation requirement of volatile substances
|
YY/T 1555.1-2017
|
|
YY/T 1564-2017
|
Cardiovascular implants - Pulmonary valve conduit - Pulsatile flow test methods
|
YY/T 1564-2017
|
|
YY/T 1591-2017
|
Human epidermal growth factor receptor(EGFR) mutation detection kit
|
YY/T 1591-2017
|
|
YY/T 1597-2017
|
Neonatal phenylalanine testing kit
|
YY/T 1597-2017
|
|
YY 1057-2016
|
General specifications for medical foot switch
|
YY 1057-2016
|
|
YY/T 0316-2016
|
Medical devices - Application of risk management to medical devices
|
YY/T 0316-2016
|
|
YY/T 0467-2016
|
Medical devices-Guidance on the selection of standards in support of recognized essential principles of safety and performance of medical devices
|
YY/T 0467-2016
|
|
YY/T 0616.1-2016
|
Medical gloves for single use - Part 1: Requirements and testing for biological evaluation
|
YY/T 0616.1-2016
|
|
YY/T 0869.1-2016
|
Medical devices - Hierarchical coding structure for adverse events - Part 1: Event-type codes
|
YY/T 0869.1-2016
|
|
YY/T 0869.2-2016
|
Medical devices. Hierarchical coding structure for adverse events. Part 2: Evaluation codes
|
YY/T 0869.2-2016
|
|
YY/T 1287.1-2016
|
Intracranial external drainage system - Part 1: Collecting sets for external drainage by intracranial puncture
|
YY/T 1287.1-2016
|
|
YY/T 1287.2-2016
|
Intracranial external drainage system--Part 2: Collecting sets for external drainage by lumbar puncture
|
YY/T 1287.2-2016
|
|
YY/T 1287.3-2016
|
Intracranial external drainage system. Part 3: Intracranial external drainage catheter
|
YY/T 1287.3-2016
|
|
YY/T 1292.3-2016
|
Test for reproductive/developmental toxicity of medical devices--Part 3: One-generation reproductive toxicity test
|
YY/T 1292.3-2016
|
|
YY/T 1406.1-2016
|
Medical device software--Part 1: Guidance on the application of ISO 14971 to medical device software
|
YY/T 1406.1-2016
|
|
YY/T 1427-2016
|
Implants for surgery. Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices
|
YY/T 1427-2016
|
|
YY/T 1434-2016
|
Medical devices for human in vitro assisted reproductive technology. In vitro mouse embryo assay
|
YY/T 1434-2016
|
|
YY/T 1437-2016
|
Medical devices--Guidance on the applicantion of ISO 14971
|
YY/T 1437-2016
|
|
YY/T 1441-2016
|
General requirements of performance evaluation of in vitro diagnostic medical devices
|
YY/T 1441-2016
|
|
YY/T 1454-2016
|
General requirements for in vitro diagnostic medical devices for self-testing
|
YY/T 1454-2016
|
|
YY/T 1465.1-2016
|
Immunogenic Evaluation Method of Medical Devices - Part 1: T Lymphocyte Transformation Test in Vitro
|
YY/T 1465.1-2016
|
|
YY/T 1465.2-2016
|
Immunogenic Evaluation Method of Medical Devices - Part 2: Serum Immunoglobulin and Complement Component Detection (Enzyme-Linked Immunosorbent Assay)
|
YY/T 1465.2-2016
|
|
YY/T 1465.3-2016
|
Immunogenic evaluation method of medical devices - Part 3: Plaque forming cells assay - Agar gel solid-phase method
|
YY/T 1465.3-2016
|
|
YY/T 1465.5-2016
|
Immunogenic evaluation method of medical devices - Part 5: Determination of ��-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibod
|
YY/T 1465.5-2016
|
|
YY/T 1473-2016
|
Guide to the development and inclusion of safety aspects in Standards for medical devices
|
YY/T 1473-2016
|
|
YY/T 1474-2016
|
Medical devices－Application of risk management to medical devices
|
YY/T 1474-2016
|
|
YY/T 1500-2016
|
Pyrogen test for medical devices. Monocyte-activation test. Human whole blood ELISA method
|
YY/T 1500-2016
|
|
YY/T 1057-2016
|
Genral specifications for medical foot switch
|
YY/T 1057-2016
|
|
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
|
YY/T 0771.4-2015
|
|
YY/T 0878.2-2015
|
Test for complement activation of medical devices - Part 2: Serum alternative pathway complement activation
|
YY/T 0878.2-2015
|
|
YY/T 0879.2-2015
|
Test for hypersensitivity of medical devices. Part 2: Marine Local Lymph Node Assay (LLNA): BrdU-ELISA method
|
YY/T 0879.2-2015
|
|
YY/T 0993-2015
|
Biological evaluation of medical devices. Nanomaterial: In vitro cytotoxicity tests (MTT assay and LDH assay)
|
YY/T 0993-2015
|
|
YY/T 0995-2015
|
Medical devices for human assisted reproductive technology. Terminology and definitions
|
YY/T 0995-2015
|
|
YY/T 1292.1-2015
|
Test for reproductive and developmental toxicity of medical devices - Part 1: Screening test
|
YY/T 1292.1-2015
|
|
YY/T 1292.2-2015
|
Test for reproductive and developmental toxicity of medical devices - Part 2: Prenatal developmental toxicity test
|
YY/T 1292.2-2015
|
|
YY/T 1295-2015
|
Biological evaluation of medical devices. Nanomaterial: Endotoxin test
|
YY/T 1295-2015
|
|
YY/T 0313-2014
|
Medical polymer products - Requirement for package and information supplied by manufacturer
|
YY/T 0313-2014
|
|
YY/T 0870.4-2014
|
Test for genotoxicity of medical devices. Part 4: Mammalian bone marrow erythocyte micronucleus test
|
YY/T 0870.4-2014
|
|
YY/T 0870.5-2014
|
Test for genotoxicity of medical devices. Part 5: Mammalian bone marrow chromosome aberration test
|
YY/T 0870.5-2014
|
|
YY/T 0916.1-2014
|
Small-bore connectors for liquids and gases in healtncare applications. Part 1: General requirements
|
YY/T 0916.1-2014
|
|
YY 0970-2013
|
Sterilization of single- use medical devices incorporating materials of animal origin. Validation and routine control of sterilization by liquid sterilants
|
YY 0970-2013
|
|
YY/T 0869-2013
|
Medical devices. Coding structure for adverse event type and cause
|
YY/T 0869-2013
|
|
YY/T 0870.1-2013
|
Test for genotoxicity of medical devices. Part 1: Bacterial reverse mutation test
|
YY/T 0870.1-2013
|
|
YY/T 0870.2-2013
|
Test for genotoxicity of medical devices. Part 2: In vitro mammalian chromosome aberration test
|
YY/T 0870.2-2013
|
|
YY/T 0870.3-2013
|
Test for genotoxicity of medical devices. Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cells
|
YY/T 0870.3-2013
|
|
YY/T 0878.1-2013
|
Test for complement activation of medical devices. Part: Serum whole complement activation
|
YY/T 0878.1-2013
|
|
YY/T 0879.1-2013
|
Test for sensitization of medical devices. Part 1: Murine local lymph node assay(LINA): Radioisotope incorporation method
|
YY/T 0879.1-2013
|
|
YY 0505-2012
|
Medical electrical equipment. Part 1-2: General requirements for safety. Collateral standard: Electromagnetic compatibility. Requirements and tests
|
YY 0505-2012
|
|
YY/T 0841-2011
|
Medical electrical equipment. Recurrent test and test after repair of medical electrical equipment
|
YY/T 0841-2011
|
|
YY/T 0817-2010
|
Physical performance requirements and test methods for enteral feeding catheters with a retention balloon
|
YY/T 0817-2010
|
|
YY/T 0269-2009
|
Dental. Orthodontic bracket adhesive materials
|
YY/T 0269-2009
|
|
YY/T 0340-2009
|
Implants for surgery. Fundamental principles
|
YY/T 0340-2009
|
|
YY/T 0511-2009
|
Test method for evaluation of the biodegradation and osteogenesis of porous bioceramic in vivo
|
YY/T 0511-2009
|
|
YY/T 0708-2009
|
Medical electrical equipment. Part 1-4: General requirements for safety. Collateral standard: Programmable electrical medical systems
|
YY/T 0708-2009
|
|
YY/T 0771.1-2009
|
Medical devices utilizing animal tissues and their derivatives. Part 1: Application of risk management
|
YY/T 0771.1-2009
|
|
YY/T 0771.2-2009
|
Medical devices utilizing animal tissues and their derivatives. Part 2: Controls on sourcing, collection and handling
|
YY/T 0771.2-2009
|
|
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
|
YY/T 0771.3-2009
|
|
YY 0666-2008
|
Method for the test of sharpness and strength of needles tips
|
YY 0666-2008
|
|
YY 0670-2008
|
Non-invasive automated sphygmomanometer
|
YY 0670-2008
|
|
YY/T 0171-2008
|
Surgical instruments. Packaging, Marking and Instructions
|
YY/T 0171-2008
|
|
YY/T 0316-2008
|
Medical devices. Application of risk management to medical devices
|
YY/T 0316-2008
|
|
YY/T 0454-2008
|
Disposable scalpel
|
YY/T 0454-2008
|
|
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
|
YY/T 0638-2008
|
|
YY/T 0639-2008
|
In Vitro Diagnostic Medical Devices. Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology
|
YY/T 0639-2008
|
|
YY/T 0664-2008
|
Medical device software - Software life cycle processes
|
YY/T 0664-2008
|
|
YY/T 0692-2008
|
Fundamental terms for biochips
|
YY/T 0692-2008
|
|
YY/T 0616-2007
|
Medical gloves for single use. Requirements and testing for biological evaluation
|
YY/T 0616-2007
|
|
YY/T 0618-2007
|
Bacterial endotoxins. Test methodologies, routine monitoring, and alternatives to batch testing
|
YY/T 0618-2007
|
|
YY/T 0149-2006
|
Medical instruments of stainless steel. Test methods of corrosion resistance
|
YY/T 0149-2006
|
|
YY/T 0176-2006
|
Surgical scissors. General specifications
|
YY/T 0176-2006
|
|
YY 0505-2005
|
Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests
|
YY 0505-2005
|
|
YY/T 0473-2004
|
Implants for surgery. Copolymers and blends based on polylactide. In vitro degradation testing
|
YY/T 0473-2004
|
|
YY/T 0474-2004
|
Poly (L-lactide) resins and fabricated forms for surgical implants. In vitro degradation testing
|
YY/T 0474-2004
|
|
YY 0466-2003
|
Medical devices-Symbols to be used with medical device labels, labelling and information to be supplied
|
YY 0466-2003
|
|
YY/T 0287-2003
|
Medical devices. Quality management systems. Requirements for regulatory purposes
|
YY/T 0287-2003
|
|
YY/T 0316-2003
|
Medical devices-Application of risk management to medical devices
|
YY/T 0316-2003
|
|
YY/T 0454-2003
|
Disposable scalper
|
YY/T 0454-2003
|
|
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
|
YY/T 0467-2003
|
|
YY/T 0468-2003
|
Nomenclature-Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange
|
YY/T 0468-2003
|
|
YY/T 0343-2002
|
Liquid penetrant inspection of metallic surgical implants
|
YY/T 0343-2002
|
|
YY/T 1074-2002
|
Implants for surgery - Measuring method for pitting corrosion potential on stainless products
|
YY/T 1074-2002
|
|
YY/T 0340-2002
|
Implants for surgery-Fundamental principles
|
YY/T 0340-2002
|
|
YY/T 0342-2002
|
Implants for surgery. Determination of bending strength and stiffness of bone plates
|
YY/T 0342-2002
|
|
YY 0033-2000
|
Good manufacture practice for sterile medical devices
|
YY 0033-2000
|
|
YY/T 0316-2000
|
Medical devices. Risk management. Part 1: Application of risk analysis
|
YY/T 0316-2000
|
|
YY 91057-1999
|
General specifications for medical foot switch
|
YY 91057-1999
|
|
YY 91016-1999
|
Vocabulary of glass syringes for medical use
|
YY 91016-1999
|
|
YY 91017-1999
|
Test method of leakage between barrel and plunger of medical glass syringes
|
YY 91017-1999
|
|
YY 0312-1998
|
General specification of aids for sex life
|
YY 0312-1998
|