CFDA issued seven new medical device industry standards

On September 28th, China Food and Drug Administration (CFDA) issued seven new medical device industry standards. Industry standards and scope of application are shown in the table.

NO.	Standard Name	Scope of Application
YY/T 0661—2017	Surgical implants Semi-crystalline poly (lactide) polymers and copolymers resins	It is suitable for the primary semi-crystalline poly (L-lactide) or poly (D- lactide) polymer resins for surgical implants, and is also suitable for the semi crystalline resins, which are copolymerization of L-lactide with other bio-absorbable monomers. It isn’t suitable for packaged, sterilized finished implants made from these materials. This standard replaces YY/T 0661-2008
YY/T 1141—2017	General specification for Bone chisel	It is suitable for orthopedic surgical instruments. This standard replaces YY/T 91141—1999,YY 91071—1999,YY 91072—1999 and YY 91073—1999.
YY/T 1426.3—2017	Surgical implants abrasion of total knee prosthesis part 3: displacement-controlled wear tester load and displacement parameters and related test conditions	It is suitable for all knee prosthesis.
YY/T 1552—2017	Surgical implants Measuring method of open-circuit potential for long-term corrosion of metallic implant materials and medical devices	It is suitable for metal materials with corrosion resistant passivation film.
YY/T 1553—2017	Cardiovascular Implant Heart Occlusion device	It is suitable for cardiac occluder, which is used for the treatment of heart defects and other diseases by Catheter implantation, and suitable for conveying system which can be used as part of the heart sealing device.
YY/T 1558.3—2017	Surgical implants calcium phosphate part 3: hydroxyapatite and β- tricalcium phosphate bone substitutes	It is not suitable for other bone filling materials containing cell bone filler, calcium phosphate bone cement or not containing hydroxyapatite and β-tricalcium phosphate.
YY/T 1567—2017	Technical requirements and test methods for female condoms

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