What are new industrial standards implemented of medical device in China from Jan 1st 2016

In order to guarantee the safety and effectiveness of medical device, China Food and Drug Administration (CFDA), the regulatory authority of medical device, has issued a series of industrial standards which would be implemented from Jan 1^st, 2016 during last year.

If you want to sell your product in China, your product shall conform to those standards which are adapted.

The list of the standards as following:

No.	Standard Name	IDT
YY/T 0058-2015	Dental patient chair	ISO 6875:2011 MOD
YY/T 0066-2015	Terms for ophthalmic optical-instruments
YY/T 0107-2015	A mode ultrasonic biometer for ophthalmology
YY/T 0113-2015	Resistance-to-abrasion capability test method for dental compound colophony
YY/T 0308-2015	Medical sodium hyaluronate gel
YY/T 0310-2015	General specifications for X-ray equipment for computed tomography
YY/T 0328-2015	Single use blood-taking set for blood processing equipment
YY/T 0330-2015	Medical purified cotton
YY/T 0466.2-2015	Medical devices -- Symbols to be used with medical device labels labelling and information to be supplied	ISO 15223:2000 IDT
YY/T 0468-2015	Nomenclature—Specification for a nomenclature system for medical devices for the purpose of regulatory data exchange	ISO 15225:2000,IDT
YY/T 0583.1-2015	Chest draining equipments for single use- Type of water-seal bottle
YY/T 0593-2015	Ultrasound transcranial doppler system
YY/T 0646-2015	Small steam sterilizers—Automatic type	NEQ EN 13060:2004
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	ISO/TR 22442-4:2010 IDT
YY/T 0803.4-2015	Dentistry—Root-canal instruments—Part 4:Auxiliary instruments	ISO3630-4:2009 MOD
YY/T 0873.6-2015	Dentistry—Number coding system for rotary instruments—Part 6:Specific characteristics of abrasive instruments	ISO6360-6:2004 IDT
YY/T 0873.6-2015	Dentistry—Number coding system for rotary instruments—Part 6:Specific characteristics of abrasive instruments	ISO6360-6:2004 IDT
YY/T 0878.2-2015	Test for complement activation of medical devices—Part 2:Serum alternative pathway complement activation
YY/T 0879.2-2015	Test for hypersensitivity of medical devices—Part 2:Murine Local Lymph Node Assay (LLNA):BrdU-ELISA method
YY/T 0912-2015	Dentistry—Brazing materials	ISO 9333:2006 IDT
YY/T 0913-2015	Dentistry—Mandrels for rotary instruments
YY/T 0914-2015	Dentistry—Laser welding
YY/T 0915-2015
YY/T 0921-2015	Medical absorbent viscose wadding
YY/T 0967.1-2015	Dental rotary instruments—Shanks—Part 1:Shanks made of metals	ISO 1797-1:1992 MOD
YY/T 0967.2-2015	Dental rotary instruments—Shanks—Part2:Shanks made of plastics	ISO 1797-2:1992 MOD
YY/T 0991-2015	Clinical trial guideline for orthodontic brackets
YY/T 0993-2015	Biological evaluation of medical devices—Nanomaterial:In vitro cytotoxicity tests(MTT assay and LDH assay)
YY/T 0994-2015	Magnetic stimulation equipment
YY/T 0995-2015	Medical devices for human assisted reproductive technology—Terminology and definitions
YY/T 0996-2015	Urine formed element analyzer(digital imaging automatic identification)
YY/T 0998-2015	Semiconductor heating and/or cooling therapy equipment
YY/T 1040.1-2015	Anaesthetic and respiratory equipment—Conical connectors—Part 1:Cones and sockets	ISO 5356-1:2004
YY/T 1084-2015	Measurement methods of ultrasonic output power for medical diagnostic ultrasonic equipments
YY/T 1095-2015	Myoelectric biofeedback equipment
YY/T 1252-2015	Total IgE quantitative labelling immunoassay kit
YY/T 1253-2015	Low density lipoprotein(LDL) cholesterol assay kit
YY/T 1254-2015	High density lipoprotein(HDL)cholesterol assay kit
YY/T 1255-2015	Immunoturbidimetry reagent (kit)
YY/T 1256-2015	Ureaplasma nucleic acid amplification detection kit
YY/T 1257-2015	Free-β-subunit of human chorionic gonadotropin quantitative labelling immunoassay kit
YY/T 1259-2015	Diagnostic kit for IgG antibody to hepatitis E virus(ELISA)
YY/T 1260-2015	Diagnostic kit for IgM antibody to hepatitis E virus(ELISA)
YY/T 1261-2015	Detection kit for analysis of HER2 gene abnormalities(fluorescent in situ hybridization )
YY/T 1262-2015	Neuron specific enolase quantitative labelling immunoassay kit
YY/T 1263-2015	Evaluation of materials of medical device subject to dry heat sterilization
YY/T 1264-2015	Evaluation of materials of medical device subject to ozone sterilization
YY/T 1265-2015	Evaluation of materials of medical device subject to moist heat sterilization
YY/T 1266-2015	Evaluation of materials of medical device subject to hydrogen peroxide sterilization
YY/T 1267-2015	Evaluation of materials of medical device subject to ethylene oxide sterilization
YY/T 1268-2015	Product adoption and process equivalence for ethylene oxide sterilization
YY/T 1269-2015	Routine control requirements for water treatment equipments for haemodialysis applications and related therapies
YY/T 1270-2015	Cardiopulmonary bypass systems—Blood lines connector
YY/T 1278-2015	Measuring methods for beam area of medical ultrasound equipment transducer
YY/T 1279-2015	Test method for performance of three-dimensional ultrasonography
YY/T 1280-2015	Dentistry—Denture adhesives
YY/T 1281-2015	Dentistry—Implants—Clinical performance of hand torque instruments
YY/T 1284.1-2015	Dental tweezers—Part 1:General requirements
YY/T 1284.2-2015	Dental tweezers—Part 2:Meriam types
YY/T 1284.3-2015	Dental tweezers—Part 3:College types
YY/T 1285-2015	Dentistry—Information system on the location of dental equipment in the working area of the oral health care provider
YY/T 1286.1-2015	Platelets storage container performances—Part 1:Determination of gas permeability of the film—Differential-pressure method
YY/T 1288-2015	Nylon blood filter nets for transfusion equipments for single use
YY/T 1292.1-2015	Test for reproductive and developmental toxicity of medical devices—Part 1:Screening test
YY/T 1292.2-2015	Test for reproductive and developmental toxicity of medical devices—Part 2:Prenatal developmental toxicity test
YY/T 1294.2-2015	Implants for Surgery—Ceramic materials—Part 2:Composite materials based on a high purity alumina matrix with zirconia reinforcemen	ISO 6474-2:2012 IDT
YY/T 1295-2015	Biological evaluation of medical devices—Nanomaterial:Endotoxin test
YY/T 1297-2015	Medical endoscopes—Endotherapy device—Curette
YY/T 1302.2-2015	Physical requirements and microbiological performance of ethylene oxide sterilization—Part 2:Microbiological aspects
YY/T 1303-2015	Nucleic acid amplification reverse dot blot reagent(kit)
YY/T 1304.1-2015	Detection system of time-resolved fluoroimmunoassay—Part 1:Semi-auto time-resolved fluoroimmunoassay analyser
YY/T 1304.2-2015	Detection system of time-resolved fluoroimmunoassay—Part 2:Quantitative reagent(kit) for time-resolved fluoroimmunoassay
YY/T 1305-2015	Clinical trial guideline for titanium and titanium alloy dental implant

More information, please contact Windy@cirs-group.com

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