SOFTWARE-BASED RISK MANAGEMENT DOCUMENTATION FOR MEDICAL DEVICES

被引：0
|
作者：
Steffen, Alexander [1 ]
Hientzsch, Dorothee [2 ]
机构：
[1] User Interface Design GmbH, Ludwigsburg, Germany
[2] Bayoonet AG, Darmstadt, Germany
来源：
BIOMEDICAL ENGINEERING-BIOMEDIZINISCHE TECHNIK | 2013年 / 58卷
关键词：
Risk management documentation; ISO; 14971; IEC 60601-1 3rd Edition; software; usability engineering;
D O I：
10.1515/bmt-2013-4236
中图分类号：
R318 [生物医学工程];
学科分类号：
0831 ;
摘要：
Manufacturers of medical devices need to fulfill the requirements of the Medical Device Directory 93/42/EWG. This text shows a way how to cope the mass of information and referring between the three standards ISO 14971, EN 62366 and 60601-1, 3rd Edition with using a special software for risk management documentation.
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页数：2
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