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.

引用

页数：2