Standards

撰稿：lzk更新日期：2020-10-21

Chinese medical device standards can be classified into different grades according to the effect and scope of standards, which are:

1) National standards

2) Industry standards

3) District standards

4) Company standards

Medical devices manufactured shall meet the national standard, or professional standards when there are no relevant national standards available. There are about 600 national standards for medical devices. Standards for CCC certificate are equivalent with IEC standards. Safety standards of medical device are equal to the standards of IEC and ISO standards. Requirements for the performance of medical equipment are mainly implementing with industry standards. For example, YY/T0106-2004 “General requirement for medical diagnostic X-ray equipment”. International recommended standards for safety become mandatory standards while converted into Chinese standards. For example, IEC601-1:1988 has been converted into Chinese national standard GB9706.1-1995.

Recently, new standards were implanted on related products in CQC, the details as following:

New standdards	superseded standards	ISSUED DATE AND IMPLEMENTED DATE	APPLICABLE PRODUCTS
Medical electrical equipment - Part 1:General requirements for safety GB9706.1-2007	Medical electrical equipment - Part 1:General requirements for safet GB9706.1-1995	Issued on July 2^nd, 2007/ Implemented on July 1^st, 2012	Electrocardiographs
			Haemodialysis equipment
			Medical X-ray Diagnostic Equipment
			Artificial heart-lung machine-Roller blood pump
			Artificial Heart-Lung Machine Pulsatile Roller Pump
			Artificial heart-lung machine-Heat exchanging water tank
Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical system GB 9706.15-2008	Medical electrical equipment - Part 1: General requirements for safety - 1. Collateral standard: Safety requirements for medical electrical systems GB9706.15-1999	Issued on Dec. 15^th, 2008 Implemented on Feb. 1^st, 2010	Medical X-ray Diagnostic Equipment
Cardiovascular implants and artificial organs－Extracorporeal blood circuit for blood purification devices YY0267-2008	Extracorporeal blood circuit for blood purification devices YY0267-1995	Issued on Apr. 25^th, 2008/ Implemented Dec.1^st, 2009	Extracorporeal blood circuit for blood purification devices
Cardiovascular implants and artificial organs－Haemodialysers, haemodiafilters, haemofilters and haemoconcentrators YY0053-2008	Cellulose triacetate hollow fiber dialyzers YY0053-91	Issued on Apr. 25^th, 2008/ Implemented Dec.1^st, 2009	Cellulose triacetate hollow fiber dialyzers

For more information please contact 86-755-83997910 or email to wrr@sist.gov.cn

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