What are new industrial standards implemented of medical device in China from Jan 1st 2016 - Regulatory News - Medical Devices

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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