Standard No.:	YY/T 0316-2003
English Name:	Medical devices -- Application of risk management to medical devices
Chinese Name:	医疗器械 风险管理对医疗器械的应用
Chinese Classification:	C30    Medical apparatus and devices in general
Professional Classification:	YY    Professional Standard - Pharmaceutics
ICS Classification:	11.040.01 11.040.01    Medical equipment in general 11.040.01
Source Content Issued by:	China Food and Drug Administration
Issued on:	2003-06-20
Implemented on:	2004-1-1
Status:	superseded
Superseded by:	YY/T 0316-2008 Medical devices - Application of risk management to medical devices
Superseded on:	2009-12-1
Superseding:	YY/T 0316-2000 Medical devices―Risk management―Part 1:Application of risk analysis
Target Language:	English
File Format:	PDF
Word Count:	12500 words
Translation Price(USD):	370.0
Delivery:	via email in 1~5 business day

本标准规定了一个程序，制造商按此程序，能够判定与医疗器械及其附件(包括体外诊断医疗器械)有关的危害，估计和评价风险，控制这些风险，并监控控制的有效性。
本标准的要求适用于医疗器械寿命周期的所有阶段。
本标准不用于和医疗器械使用有关的临床判断。 它不规定可接受的风险水平.
本标准不要求制造商有一个适当的正规质量体系。然而风险管理可以是质量体系的一个组成部分(例如:参见附录G中表G.1).