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Chinese National Standard List: Medical apparatus and devices in general

Title Standard No. Implemented On
General technical requirement for chromosomal abnormality detection microarrayGB/T 35533-2017
In vitro diagnostic medical devices-Information supplied by the manufacturer with in vitro diagnostic reagents for staining in biology YY/T 0639-20192020-8-1
Human chorionic gonadotrophin detection kitYY/T 1214-20192020-8-1
Small-bore connectors for liquids and gases in healthcare applications―Part 20:Common test methodsYY/T 0916.20-20192020-8-1
Test for genotoxicity of medical devices―Part 3:TK gene mutation test using mouse lymphoma cellsYY/T 0870.3-20192020-8-1
Test for genotoxicity of medical devices―Part 6:In vitro mammalian cell micronucleus testYY/T 0870.6-20192020-8-1
Test for complement activation of medical devices―Part 3：Assay for the product of complement activation (C3a and SC5b-9)YY/T 0878.3-20192020-8-1
Basic terms of unique device identification systemYY/T 1681-20192020-8-1
Preimplantation chromosomal aneuploidies detection kits (Sequencing)YY/T 1657-20192020-8-1
Immunogenic evaluation method of medical devices―Part 6:Determination of animal spleen lymphocyte subsets by flow cytometryYY/T 1465.6-20192020-8-1
Evaluation of neurotoxicity of medical devices―Part 1:Standard guide for selecting tests to evaluate potential neurotoxicityYY/T 1670.1-20192020-8-1
Test method for interactions of medical devices with platelet—Part 1:In vitro platelet count assayYY/T 1649.1-20192020-6-1
Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration testYY/T 0870.2-20192020-6-1
Tests for hemolysis of medical devices—Part 1:Material induced hemolysis assayYY/T 1651.1-20192020-6-1
General analysis regulation of the label-free protein microarray based on imaging ellipsometryGB/T 37908-20192020-5-1
Biological evaluation of medical devices—Part 3:Tests for genotoxicity, carcinogenicity and reproductive toxicityGB/T 16886.3-20192020-1-1
Human immunodeficiency virus antibodies detection kits(Immuno-chromatography)YY/T 1611-20182020-1-1
Fundamental requirements for unique device identifierYY/T 1630-20182020-1-1
Functional and compatibility test methods for remote medical imaging equipmentYY/T 1643-20182020-1-1
Particular requirements for the silicone gel filled breast implant―Performance requirement of silicone gel filler―Part 2:Limits requirement for extractable substancesYY/T 1555.2-20182020-1-1
Medical laboratories—Requirements for quality and competence—Part 1:General requirementsGB/T 22576.1-20182019-7-1
ABO forward blood grouping and RhD typing reagents(column agglutination technique,CAT)YY/T 1592-20182019-3-1
Growth hormone testing kitYY/T 1593-20182019-3-1
Human epidermal growth factor receptor(EGFR) mutation detection kitYY/T 1591-20172018-12-1
Neonatal phenylalanine testing kitYY/T 1597-20172018-12-1
General requirements of DNA array-based M. tuberculosis drug resistance detectionGB/T 36136-20182018-12-1
Method based the microarray for mutation detetion of hereditary hearing lossGB/T 35029-20182018-12-1
Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management processYY/T 1512-20172018-7-1
Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitizationGB/T 16886.10-20172018-7-1
Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation productsGB/T 16886.9-20172018-7-1
Biological evaluation of medical devices—Part 12:Sample preparation and reference materialsGB/T 16886.12-20172018-7-1
Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicityGB/T 16886.5-20172018-7-1
Biological evaluation of medical devices—Nanomaterials—Hemolysis testYY/T 1532-20172018-4-1
Particular requirement of silicone gel filled breast implant-Performance requirement of silicone gel filler-Part 1:Limitation requirement of volatile substancesYY/T 1555.1-20172018-4-1
Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testingYY/T 0618-20172018-1-1
Genral specifications for medical foot switchYY 1057-20162018-1-1
Technical requirement of laser confocal biochip scannerGB/T 33805-20172017-12-1
Technical requirement of area fluorescent imaging microarray scannerGB/T 33806-20172017-12-1
Aldehyde slide for microarraysGB/T 33752-20172017-12-1
Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturerGB 16174.1-20152017-7-1
Pyrogen test for medical devices―Monocyte-activation test―Human whole blood ELISA methodYY/T 1500-20162017-6-1
Immunogenic evaluation method of medical devices- Part 5:Determination of a-Gal antigen clearance in medical devices utilizing animal tissues and their derivatives with M86 antibodyYY/T 1465.5-20162017-6-1
Medical devices-Quality management systems- Requirements for regulatory purposes YY/T 0287-20172017-5-1
Biological evaluation of medical devices―Part 6:Tests for local effects after implantationGB/T 16886.6-20152017-4-1
Medical gloves for single use―Part 1:Requirements and testing for biological evaluationYY/T 0616.1-20162017-1-1
Guide to the development and inclusion of safety aspects in Standards for medical devicesYY/T 1473-20162017-1-1
Medical devices—Guidance on the applicantion of ISO 14971YY/T 1437-20162017-1-1
Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay)YY/T 1465.2-20162017-1-1
Medical devices-Application of risk management to medical devicesYY/T 0316-20162017-1-1
Implants for surgery—Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devicesYY/T 1427-20162017-1-1
Intracranial external drainage system—Part 2:Collecting sets for external drainage by lumbar punctureYY/T 1287.2-20162017-1-1
Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devicesGB/T 16886.20-20152017-1-1
General requirements of performance evaluation of in vitro diagnostic medical devicesYY/T 1441-20162017-1-1
Test for reproductive/developmental toxicity of medical devices—Part 3:One-generation reproductive toxicity testYY/T 1292.3-20162017-1-1
Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitroYY/T 1465.1-20162017-1-1
Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device softwareYY/T 1406.1-20162017-1-1
Medical devices－Application of risk management to medical devicesYY/T 1474-20162017-1-1
General requirements for in vitro diagnostic medical devices for self-testingYY/T 1454-20162017-1-1
Medical devices for human in vitro assisted reproductive technology—In vitro mouse embryo assayYY/T 1434-20162017-1-1
Intracranial external drainage system—Part 1:Collecting sets for external drainage by intracranial punctureYY/T 1287.1-20162017-1-1
Medical devices—Hierarchical coding structure for adverse events—Part 1:Event-type codesYY/T 0869.1-20162017-1-1
Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)YY/T 0993-20152016-1-1
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 processesYY/T 0771.4-20152016-1-1
Medical devices for human assisted reproductive technology―Terminology and definitionsYY/T 0995-20152016-1-1
Biological evaluation of medical devices―Nanomaterial:Endotoxin testYY/T 1295-20152016-1-1
Test for reproductive and developmental toxicity of medical devices―Part 1:Screening testYY/T 1292.1-20152016-1-1
Test for reproductive and developmental toxicity of medical devices―Part 2:Prenatal developmental toxicity testYY/T 1292.2-20152016-1-1
Test for complement activation of medical devices―Part 2:Serum alternative pathway complement activationYY/T 0878.2-20152016-1-1
Test for genotoxicity of medical devices―Part 5:Mammalian bone marrow chromosome aberration testYY/T 0870.5-20142015-7-1
Small-bore connectors for liquids and gases in healthcare applications―Part 1:General requirementsYY/T 0916.1-20142015-7-1
Test for genotoxicity of medical devices―Part 4:Mammalian bone marrow erythocyte micronucleus testYY/T 0870.4-20142015-7-1
Test methods for ureteral stentsYY/T 0872-20132014-10-1
Complement activation test for medical devices - Part 1: Serum complement activationYY/T 0878.1-20132014-10-1
Test for genotoxicity of medical devices - Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cell YY/T 0870.3-20132014-10-1
Sterilization of single-use medical devices incorporating materials of animal origin―Validation and routine control of sterilization by liquid sterilantsYY 0970-20132014-10-1
Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration testYY/T 0870.2-20132014-10-1
Medical devices—Coding structure for adverse event type and causeYY/T 0869-20132014-10-1
Test for genotoxicity of medical devices - Part 1: Bacterial reverse mutation testYY/T 0870.1-20132014-10-1
Test for sensitization of medical devices - Part 1: Murine local lymph node assay (LLNA), radioisotope incorporation method YY/T 0879.1-20132014-10-1
Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachablesGB/T 16886.16-20132014-8-1
General requirements of DNA array-based mycobacteria identificationGB/T 29888-20132014-4-11
DNA microarray for disease susceptibility DNA polymorphismsGB/T 29889-20132014-4-11
Point-of-care testing(POCT)— Requirements for quality and competenceGB/T 29790-20132014-2-1
Medical electrical equipment－Part 1-2:General requirements for safety－Collateral stanards：Electromagnetic compatibility－Requirements and testsYY 0505-20122014-1-1
Medical electrical equipment—Recurrent test and test after repair of medical electrical equipmentYY/T 0841-20112013-6-1
Physical performance requirements and test methods for enteral feeding catheters with a retention balloonYY/T 0817-20102012-6-1
Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materialsGB/T 16886.19-20112012-5-1
Biological evaluation of medical devices—Part 2:Animal welfare requirementsGB/T 16886.2-20112012-5-1
Biological evaluation of medical devices—Part 11:Tests for systemic toxicityGB/T 16886.11-20112012-5-1
Biological evaluation of medical devices—Part 18:Chemical characterization of materialsGB/T 16886.18-20112012-5-1
Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management processGB/T 16886.1-20112011-12-1
Specifications of radiological protection and monitoring assessment for the radiotherapy room of medical electron acceleratorDB31/T 527-20112011-7-1
Specifications of radiological protection and monitoring assessment for the radiotherapy room of medical electron acceleratorDB31/ 527-20112011-7-1
Adjustable rehabilitation training bedGB/T 26340-20102011-5-1
Rehabilitation training instrument—Quadriceps training chairGB/T 26346-20102011-5-1
Test method for settling microbe in clean room(zone) of the pharmaceutical industryGB/T 16294-20102011-2-1
Test method for airborne particles in clean room(zone) of the pharmaceutical industryGB/T 16292-20102011-2-1
Test method for airborne microbe in clean room(zone) of the pharmaceutical industryGB/T 16293-20102011-2-1
dical electrical equipment—Part 1-4:General requirements for safety—collateral standard:programmable electrical medical systemsYY/T 0708-20092010-12-1
cal electrical equipment—Part 1-8:General requirements for safety—Collateral standard:General requirements,tests and guidance for alarm systems in medical electrical equipment and medical electrical systemsYY 0709-20092010-12-1
Non-invasive automated sphygmomanometerYY 0670-20082010-6-1
Method for the test of sharpness and strength of needles tipsYY 0666-20082010-6-1
Environmental requirement and test methods for medical electrical equipmentGB/T 14710-20092010-5-1
Medical laboratories - Particular requirements for quality and competenceGB/T 22576-20082010-2-1
Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systemsGB 9706.15-20082010-2-1
Surgical instruments - Packaging, Marking and InstructionsYY/T 0171-20082010-1-1
Fundamental terms for biochipsYY/T 0692-20082010-1-1
Surgical instruments-Non-cutting, articulated instruments General specificationsYY/T 0687-20082010-1-1
Medical devices - Application of risk management to medical devicesYY/T 0316-20082009-12-1
and orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthosesGB/T 14191.1-20092009-9-1
In Vitro Diagnostic Medical Devices-Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in BiologyYY/T 0639-20082009-6-1
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 materialsYY/T 0638-20082009-6-1
Medical device software - Software life cycle processesYY/T 0664-20082009-6-1
Laboratory medicine - Requirements for reference measurement laboratories GB/T 21919-20082009-1-1
Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicityGB/T 16886.3-20082008-9-1
Biological evaluation test methods for medical organic silicon materialsGB/T 16175-20082008-9-1
Medical electrical equipment—Part 1:General requirements for safetyGB 9706.1-20072008-7-1
Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testingYY/T 0618-20072008-3-1
Medical gloves for single use—Requirements and testing for biological evaluationYY/T 0616-20072008-3-1
Surgical Scissors—General specificationsYY/T 0176-20062007-5-1
Medical instruments of stainless steel - Test methods of corrosion resistanceYY/T 0149-20062007-5-1
Biological evaluation of medical devices - Part 17 : Estabilishment of allowable limits for leachable substancesGB/T 16886.17-20052006-4-1
In vitroGB/T 19702-20052005-12-1
Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivityGB/T 16886.10-20052005-12-1
In vitroGB/T 19703-20052005-12-1
Biological evaluation of medical devices-Part 12:Sample preparation and reference materialsGB/T 16886.12-20052005-12-1
Packaging for terminally sterilized medical devicesGB/T 19633-20052005-5-1
Poly(L-lactide) resins and fabricated forms for surgical implants - YY/T 0474-20042005-1-1
Implants for surgery - Copolymers and blends based on polylactide - YY/T 0473-20042005-1-1
Medical devices - Quality management systems - Requirements for regulatory purposesYY/T 0287-20032004-4-1
Medical devices -- Symbols to be used with medical device labels labelling and information to be suppliedYY 0466-20032004-1-1
Medical devices -- Application of risk management to medical devicesYY/T 0316-20032004-1-1
Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchangeYY/T 0468-20032004-1-1
Medical devices - Guide to the selection of standards in support of recognized essential principles of safety and performance of medical devicesYY/T 0467-20032004-1-1
Biological evaluation of medical devices - Part 4: Selection of tests for interactions with bloodGB/T 16886.4-20032003-8-1
Radiotherapy equipment—Coordinates,movements and scalesGB/T 18987-20032003-8-1
Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicityGB/T 16886.5-20032003-8-1
Biological evaluation of medical devices--Part 14:Identification and quantificaton of degradation products from ceramicsGB/T 16886.14-20032003-8-1
Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloysGB/T 16886.15-20032003-8-1
Implants for surgery--Measuring method for pitting corrosion potential on stainless productsYY/T 1074-20022003-4-1
Implants for surgery--Fundamental principlesYY/T 0340-20022003-4-1
Implants for surgery--Determination of bending strength and stiffness of bone platesYY/T 0342-20022003-4-1
Liquid penetrant inspection of metallic surgical implantsYY/T 0343-20022003-4-1
Medical electrical equipment?Part 2:Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectorsGB 9706.21-20032003-1-2
Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devicesGB/T 16886.13-20012002-2-1
Biological evaluation of medical devices--Part 1:Evaluation and testingGB/T 16886.1-20012002-2-1
Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation productsGB/T 16886.9-20012002-2-1
Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residualsGB/T 16886.7-20012002-2-1
Guidelines for the development and use of medical electrical equipment educational materialsGB/Z 17994-19992001-8-1
Biological evaluation of medical devices-Part 12:Sample preparation and reference materialsGB/T 16886.12-20002001-5-1
Biological evaluation of medical devices-Part 10:Tests for irritation and sensitizationGB/T 16886.10-20002001-5-1
Biological evaluation of medical devices--Part 2:Animal welfare requirementsGB/T 16886.2-20002001-5-1
Good manufacture practice for sterile medical devicesYY 0033-20002000-9-15
Guidelines for administrative, medical,and nursing staff concerned with the safe use of medical electrical equipmentGB/T 17995-19992000-8-1
Medical devices―Risk management―Part 1:Application of risk analysisYY/T 0316-20002000-7-1
Guidelines for radiotherapy treatment rooms designGB/T 17827-19992000-5-1
Medical radiology--Terminology （Equipment for radiotherapy，nuclear medicine and radiation dosimetry）GB/T 17857-19992000-1-1
Clinical investigation of medical devicesYY/T 0297-19971998-1-1
Biological evaluation of medical devices--Part 5:Tests for cytotoxicity:in vitro methodsGB/T 16886.5-19971997-12-1
Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicityGB/T 16886.3-19971997-12-1
Biological evaluation of medical devices--Part 6:Tests for local effects after implantationGB/T 16886.6-19971997-12-1
Biological evaluation of medical devices --Part 1:Guidance on selection of testsGB/T 16886.1-19971997-12-1
Biological evaluation of medical devices--Part 11: Tests for systemic toxicityGB/T 16886.11-19971997-1-2
Medical electrical equipment--Part 1:General requirements for safetyGB 9706.1-19951996-1-2
Medical instruments of stainless steel -- Test methods of corrosion resistanceYY/T 0149-19931994-7-1
The environmental requirements and test methods for medical electrical equipmentGB/T 14710-19931994-6-1
Terminology for prostherics and orthoticsGB/T 14191-19931993-9-1
Coating classifications for metal product - Technical conditionsYY 0076-19921992-7-1
General specifications for medical foot switchYY 91057-19991988-3-1
Test method of leakage between barrel and plunger of medical glass syringesYY 91017-19991988-1-1
Vocabulary of glass syringes for medical useYY 91016-19991988-1-1
Evaluating requirements for corrosion test of electroplated metallic coatings of medical instrumentsYY/T 91056-19991987-7-1
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