| Title |
Standard No. |
Implemented On |
| General technical requirement for chromosomal abnormality detection microarray | GB/T 35533-2017 | |
| Medical laboratories—Requirements for quality and competence—Part 1:General requirements | GB/T 22576.1-2018 | 2019-7-1 |
| ABO forward blood grouping and RhD typing reagents(column agglutination technique,CAT) | YY/T 1592-2018 | 2019-3-1 |
| Growth hormone testing kit | YY/T 1593-2018 | 2019-3-1 |
| Human epidermal growth factor receptor(EGFR) mutation detection kit | YY/T 1591-2017 | 2018-12-1 |
| Neonatal phenylalanine testing kit | YY/T 1597-2017 | 2018-12-1 |
| Method based the microarray for mutation detetion of hereditary hearing loss | GB/T 35029-2018 | 2018-12-1 |
| Biological evaluation of medical devices—Guidance on the conduct of biological evaluation within a risk management process | YY/T 1512-2017 | 2018-7-1 |
| Biological evaluation of medical devices―Part 10:Tests for irritation and skin sensitization | GB/T 16886.10-2017 | 2018-7-1 |
| Biological evaluation of medical devices―Part 9:Framework for identification and quantification of potential degradation products | GB/T 16886.9-2017 | 2018-7-1 |
| Biological evaluation of medical devices—Part 12:Sample preparation and reference materials | GB/T 16886.12-2017 | 2018-7-1 |
| Biological evaluation of medical devices―Part 5:Tests for in vitro cytotoxicity | GB/T 16886.5-2017 | 2018-7-1 |
| Biological evaluation of medical devices—Nanomaterials—Hemolysis test | YY/T 1532-2017 | 2018-4-1 |
| 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 | 2018-4-1 |
| Test methods for bacterial endotoxins of medical devices―Routine monitoring and alternatives to batch testing | YY/T 0618-2017 | 2018-1-1 |
| Genral specifications for medical foot switch | YY 1057-2016 | 2018-1-1 |
| Technical requirement of laser confocal biochip scanner | GB/T 33805-2017 | 2017-12-1 |
| Technical requirement of area fluorescent imaging microarray scanner | GB/T 33806-2017 | 2017-12-1 |
| Aldehyde slide for microarrays | GB/T 33752-2017 | 2017-12-1 |
| Implants for surgery—Active implantable medical devices—Part 1: General requirements for safety, marking and for information to be provided by the manufacturer | GB 16174.1-2015 | 2017-7-1 |
| Pyrogen test for medical devices―Monocyte-activation test―Human whole blood ELISA method | YY/T 1500-2016 | 2017-6-1 |
| 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 antibody | YY/T 1465.5-2016 | 2017-6-1 |
| Medical devices-Quality management systems- Requirements for regulatory purposes | YY/T 0287-2017 | 2017-5-1 |
| Biological evaluation of medical devices―Part 6:Tests for local effects after implantation | GB/T 16886.6-2015 | 2017-4-1 |
| Medical gloves for single use―Part 1:Requirements and testing for biological evaluation | YY/T 0616.1-2016 | 2017-1-1 |
| Guide to the development and inclusion of safety aspects in Standards for medical devices | YY/T 1473-2016 | 2017-1-1 |
| Medical devices—Guidance on the applicantion of ISO 14971 | YY/T 1437-2016 | 2017-1-1 |
| Immunogenic evaluation method of medical devices—Part 2:Serum immunoglobulin and complement component detection(enzyme-linked immunoadsordent assay) | YY/T 1465.2-2016 | 2017-1-1 |
| Medical devices-Application of risk management to medical devices | YY/T 0316-2016 | 2017-1-1 |
| Implants for surgery—Test solutions and environmental condition for static and dynamic corrosion tests on implantable materials and medical devices | YY/T 1427-2016 | 2017-1-1 |
| Intracranial external drainage system—Part 2:Collecting sets for external drainage by lumbar puncture | YY/T 1287.2-2016 | 2017-1-1 |
| Biological evaluation of medical devices―Part 20:Principles and methods for immunotoxicology testing of medical devices | GB/T 16886.20-2015 | 2017-1-1 |
| General requirements of performance evaluation of in vitro diagnostic medical devices | YY/T 1441-2016 | 2017-1-1 |
| Test for reproductive/developmental toxicity of medical devices—Part 3:One-generation reproductive toxicity test | YY/T 1292.3-2016 | 2017-1-1 |
| Immunogenic evaluation method of medical devices —Part 1:T Lymphocyte transformation test in vitro | YY/T 1465.1-2016 | 2017-1-1 |
| Medical device software—Part 1:Guidance on the application of ISO 14971 to medical device software | YY/T 1406.1-2016 | 2017-1-1 |
| Medical devices－Application of risk management to medical devices | YY/T 1474-2016 | 2017-1-1 |
| General requirements for in vitro diagnostic medical devices for self-testing | YY/T 1454-2016 | 2017-1-1 |
| Medical devices for human in vitro assisted reproductive technology—In vitro mouse embryo assay | YY/T 1434-2016 | 2017-1-1 |
| Intracranial external drainage system—Part 1:Collecting sets for external drainage by intracranial puncture | YY/T 1287.1-2016 | 2017-1-1 |
| Medical devices—Hierarchical coding structure for adverse events—Part 1:Event-type codes | YY/T 0869.1-2016 | 2017-1-1 |
| Biological evaluation of medical devices―Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay) | YY/T 0993-2015 | 2016-1-1 |
| 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 processes | YY/T 0771.4-2015 | 2016-1-1 |
| Medical devices for human assisted reproductive technology―Terminology and definitions | YY/T 0995-2015 | 2016-1-1 |
| Biological evaluation of medical devices―Nanomaterial:Endotoxin test | YY/T 1295-2015 | 2016-1-1 |
| Test for reproductive and developmental toxicity of medical devices―Part 1:Screening test | YY/T 1292.1-2015 | 2016-1-1 |
| Test for reproductive and developmental toxicity of medical devices―Part 2:Prenatal developmental toxicity test | YY/T 1292.2-2015 | 2016-1-1 |
| Test for complement activation of medical devices―Part 2:Serum alternative pathway complement activation | YY/T 0878.2-2015 | 2016-1-1 |
| Test for genotoxicity of medical devices―Part 5:Mammalian bone marrow chromosome aberration test | YY/T 0870.5-2014 | 2015-7-1 |
| Small-bore connectors for liquids and gases in healthcare applications―Part 1:General requirements | YY/T 0916.1-2014 | 2015-7-1 |
| Test for genotoxicity of medical devices―Part 4:Mammalian bone marrow erythocyte micronucleus test | YY/T 0870.4-2014 | 2015-7-1 |
| Test methods for ureteral stents | YY/T 0872-2013 | 2014-10-1 |
| Complement activation test for medical devices - Part 1: Serum complement activation | YY/T 0878.1-2013 | 2014-10-1 |
| Test for genotoxicity of medical devices - Part 3: In vitro mammalian cell gene mutation test using mouse lymphoma cell | YY/T 0870.3-2013 | 2014-10-1 |
| Sterilization of single-use medical devices incorporating materials of animal origin―Validation and routine control of sterilization by liquid sterilants | YY 0970-2013 | 2014-10-1 |
| Test for genotoxicity of medical devices—Part 2:In vitro mammalian chromosome aberration test | YY/T 0870.2-2013 | 2014-10-1 |
| Medical devices—Coding structure for adverse event type and cause | YY/T 0869-2013 | 2014-10-1 |
| Test for genotoxicity of medical devices - Part 1: Bacterial reverse mutation test | YY/T 0870.1-2013 | 2014-10-1 |
| Test for sensitization of medical devices - Part 1: Murine local lymph node assay (LLNA), radioisotope incorporation method | YY/T 0879.1-2013 | 2014-10-1 |
| Biological evaluation of medical devices—Part 16:Toxicokinetic study design for degradation products and leachables | GB/T 16886.16-2013 | 2014-8-1 |
| General requirements of DNA array-based mycobacteria identification | GB/T 29888-2013 | 2014-4-11 |
| DNA microarray for disease susceptibility DNA polymorphisms | GB/T 29889-2013 | 2014-4-11 |
| Point-of-care testing(POCT)— Requirements for quality and competence | GB/T 29790-2013 | 2014-2-1 |
| Medical electrical equipment－Part 1-2:General requirements for safety－Collateral stanards：Electromagnetic compatibility－Requirements and tests | YY 0505-2012 | 2014-1-1 |
| Medical electrical equipment—Recurrent test and test after repair of medical electrical equipment | YY/T 0841-2011 | 2013-6-1 |
| Physical performance requirements and test methods for enteral feeding catheters with a retention balloon | YY/T 0817-2010 | 2012-6-1 |
| Biological evaluation of medical devices—Part 19:Physico-chemical,morphological and topographical characterization of materials | GB/T 16886.19-2011 | 2012-5-1 |
| Biological evaluation of medical devices—Part 2:Animal welfare requirements | GB/T 16886.2-2011 | 2012-5-1 |
| Biological evaluation of medical devices—Part 11:Tests for systemic toxicity | GB/T 16886.11-2011 | 2012-5-1 |
| Biological evaluation of medical devices—Part 18:Chemical characterization of materials | GB/T 16886.18-2011 | 2012-5-1 |
| Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process | GB/T 16886.1-2011 | 2011-12-1 |
| Specifications of radiological protection and monitoring assessment for the radiotherapy room of medical electron accelerator | DB31/T 527-2011 | 2011-7-1 |
| Specifications of radiological protection and monitoring assessment for the radiotherapy room of medical electron accelerator | DB31/ 527-2011 | 2011-7-1 |
| Adjustable rehabilitation training bed | GB/T 26340-2010 | 2011-5-1 |
| Rehabilitation training instrument—Quadriceps training chair | GB/T 26346-2010 | 2011-5-1 |
| Test method for settling microbe in clean room(zone) of the pharmaceutical industry | GB/T 16294-2010 | 2011-2-1 |
| Test method for airborne particles in clean room(zone) of the pharmaceutical industry | GB/T 16292-2010 | 2011-2-1 |
| Test method for airborne microbe in clean room(zone) of the pharmaceutical industry | GB/T 16293-2010 | 2011-2-1 |
| dical electrical equipment—Part 1-4:General requirements for safety—collateral standard:programmable electrical medical systems | YY/T 0708-2009 | 2010-12-1 |
| 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 systems | YY 0709-2009 | 2010-12-1 |
| Non-invasive automated sphygmomanometer | YY 0670-2008 | 2010-6-1 |
| Method for the test of sharpness and strength of needles tips | YY 0666-2008 | 2010-6-1 |
| Environmental requirement and test methods for medical electrical equipment | GB/T 14710-2009 | 2010-5-1 |
| Medical laboratories - Particular requirements for quality and competence | GB/T 22576-2008 | 2010-2-1 |
| Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems | GB 9706.15-2008 | 2010-2-1 |
| Surgical instruments - Packaging, Marking and Instructions | YY/T 0171-2008 | 2010-1-1 |
| Fundamental terms for biochips | YY/T 0692-2008 | 2010-1-1 |
| Surgical instruments-Non-cutting, articulated instruments General specifications | YY/T 0687-2008 | 2010-1-1 |
| Medical devices - Application of risk management to medical devices | YY/T 0316-2008 | 2009-12-1 |
| and orthotics - Vocabulary - Part 1: General terms for external limb prostheses and external orthoses | GB/T 14191.1-2009 | 2009-9-1 |
| In Vitro Diagnostic Medical Devices-Information Supplied by the Manufacturer with in Vitro Diagnostic Reagents for Staining in Biology | YY/T 0639-2008 | 2009-6-1 |
| 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 materials | YY/T 0638-2008 | 2009-6-1 |
| Medical device software - Software life cycle processes | YY/T 0664-2008 | 2009-6-1 |
| Laboratory medicine - Requirements for reference measurement laboratories | GB/T 21919-2008 | 2009-1-1 |
| Biological evaluation of medical devices - Part 3: Tests for genotoxicity carcinogenicity and reproductive toxicity | GB/T 16886.3-2008 | 2008-9-1 |
| Biological evaluation test methods for medical organic silicon materials | GB/T 16175-2008 | 2008-9-1 |
| Medical electrical equipment—Part 1:General requirements for safety | GB 9706.1-2007 | 2008-7-1 |
| Bacterial endotoxins—Test methodologies routine monitoring and alternatives to batch testing | YY/T 0618-2007 | 2008-3-1 |
| Medical gloves for single use—Requirements and testing for biological evaluation | YY/T 0616-2007 | 2008-3-1 |
| Surgical Scissors—General specifications | YY/T 0176-2006 | 2007-5-1 |
| Medical instruments of stainless steel - Test methods of corrosion resistance | YY/T 0149-2006 | 2007-5-1 |
| Biological evaluation of medical devices - Part 17 : Estabilishment of allowable limits for leachable substances | GB/T 16886.17-2005 | 2006-4-1 |
| In vitro | GB/T 19702-2005 | 2005-12-1 |
| Biological evaluation of medical devices-Part 10:Tests for irritation and delayed-type hypersensitivity | GB/T 16886.10-2005 | 2005-12-1 |
| In vitro | GB/T 19703-2005 | 2005-12-1 |
| Biological evaluation of medical devices-Part 12:Sample preparation and reference materials | GB/T 16886.12-2005 | 2005-12-1 |
| Packaging for terminally sterilized medical devices | GB/T 19633-2005 | 2005-5-1 |
| Poly(L-lactide) resins and fabricated forms for surgical implants - | YY/T 0474-2004 | 2005-1-1 |
| Implants for surgery - Copolymers and blends based on polylactide - | YY/T 0473-2004 | 2005-1-1 |
| Medical devices - Quality management systems - Requirements for regulatory purposes | YY/T 0287-2003 | 2004-4-1 |
| Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied | YY 0466-2003 | 2004-1-1 |
| Medical devices -- Application of risk management to medical devices | YY/T 0316-2003 | 2004-1-1 |
| Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange | YY/T 0468-2003 | 2004-1-1 |
| 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 | 2004-1-1 |
| Biological evaluation of medical devices - Part 4: Selection of tests for interactions with blood | GB/T 16886.4-2003 | 2003-8-1 |
| Radiotherapy equipment—Coordinates,movements and scales | GB/T 18987-2003 | 2003-8-1 |
| Biological evaluation of medical devices - Part 5: Test for in vitro cytotoxicity | GB/T 16886.5-2003 | 2003-8-1 |
| Biological evaluation of medical devices--Part 14:Identification and quantificaton of degradation products from ceramics | GB/T 16886.14-2003 | 2003-8-1 |
| Biological eveluation of medical devices--Part 15:Inentificatoin and quantificatoin of degradation products from metals and alloys | GB/T 16886.15-2003 | 2003-8-1 |
| Implants for surgery--Measuring method for pitting corrosion potential on stainless products | YY/T 1074-2002 | 2003-4-1 |
| Implants for surgery--Fundamental principles | YY/T 0340-2002 | 2003-4-1 |
| Implants for surgery--Determination of bending strength and stiffness of bone plates | YY/T 0342-2002 | 2003-4-1 |
| Liquid penetrant inspection of metallic surgical implants | YY/T 0343-2002 | 2003-4-1 |
| Medical electrical equipment?Part 2:Particular requirements for the safety of patient contact dosemeters used in radiotherapy with electrically connected radiation detectors | GB 9706.21-2003 | 2003-1-2 |
| Biogical evaluation of medical devices - Part 13: Identification and quantification of degradation products from polymeric medical devices | GB/T 16886.13-2001 | 2002-2-1 |
| Biological evaluation of medical devices--Part 1:Evaluation and testing | GB/T 16886.1-2001 | 2002-2-1 |
| Biological evaluation of medical devices - Part 9: Framework for identification and quantification of potential degradation products | GB/T 16886.9-2001 | 2002-2-1 |
| Biological evaluation of medical devices - Part 7: Ethylene oxide sterilization residuals | GB/T 16886.7-2001 | 2002-2-1 |
| Guidelines for the development and use of medical electrical equipment educational materials | GB/Z 17994-1999 | 2001-8-1 |
| Biological evaluation of medical devices-Part 12:Sample preparation and reference materials | GB/T 16886.12-2000 | 2001-5-1 |
| Biological evaluation of medical devices-Part 10:Tests for irritation and sensitization | GB/T 16886.10-2000 | 2001-5-1 |
| Biological evaluation of medical devices--Part 2:Animal welfare requirements | GB/T 16886.2-2000 | 2001-5-1 |
| Good manufacture practice for sterile medical devices | YY 0033-2000 | 2000-9-15 |
| Guidelines for administrative, medical,and nursing staff concerned with the safe use of medical electrical equipment | GB/T 17995-1999 | 2000-8-1 |
| Medical devices―Risk management―Part 1:Application of risk analysis | YY/T 0316-2000 | 2000-7-1 |
| Guidelines for radiotherapy treatment rooms design | GB/T 17827-1999 | 2000-5-1 |
| Medical radiology--Terminology （Equipment for radiotherapy，nuclear medicine and radiation dosimetry） | GB/T 17857-1999 | 2000-1-1 |
| Clinical investigation of medical devices | YY/T 0297-1997 | 1998-1-1 |
| Biological evaluation of medical devices--Part 5:Tests for cytotoxicity:in vitro methods | GB/T 16886.5-1997 | 1997-12-1 |
| Biological evaluation of medical devices--Part 3:Tests for genotoxicity,carcinogenicity and reproductive toxicity | GB/T 16886.3-1997 | 1997-12-1 |
| Biological evaluation of medical devices--Part 6:Tests for local effects after implantation | GB/T 16886.6-1997 | 1997-12-1 |
| Biological evaluation of medical devices --Part 1:Guidance on selection of tests | GB/T 16886.1-1997 | 1997-12-1 |
| Biological evaluation of medical devices--Part 11: Tests for systemic toxicity | GB/T 16886.11-1997 | 1997-1-2 |
| Medical electrical equipment--Part 1:General requirements for safety | GB 9706.1-1995 | 1996-1-2 |
| Medical instruments of stainless steel -- Test methods of corrosion resistance | YY/T 0149-1993 | 1994-7-1 |
| The environmental requirements and test methods for medical electrical equipment | GB/T 14710-1993 | 1994-6-1 |
| Terminology for prostherics and orthotics | GB/T 14191-1993 | 1993-9-1 |
| Coating classifications for metal product - Technical conditions | YY 0076-1992 | 1992-7-1 |
| General specifications for medical foot switch | YY 91057-1999 | 1988-3-1 |
| Test method of leakage between barrel and plunger of medical glass syringes | YY 91017-1999 | 1988-1-1 |
| Vocabulary of glass syringes for medical use | YY 91016-1999 | 1988-1-1 |
| Evaluating requirements for corrosion test of electroplated metallic coatings of medical instruments | YY/T 91056-1999 | 1987-7-1 |
