Risk Management of the New Dynamic Spinal Stabilization System

被引：0

作者：

Kuo, R. F. ^{[1
]}

Yang, C. J. ^{[1
]}

Lin, R. M. ^{[2
]}

Weng, C. H. ^{[1
]}

机构：

[1] Natl Cheng Kung Univ, Med Device Innovat Ctr, Tainan 70101, Taiwan

[2] Natl Cheng Jung Univ Hosp, Orthoped Dept, Tainan, Taiwan

来源：

1ST GLOBAL CONFERENCE ON BIOMEDICAL ENGINEERING & 9TH ASIAN-PACIFIC CONFERENCE ON MEDICAL AND BIOLOGICAL ENGINEERING | 2015年 / 47卷

关键词：

Dynamic Spinal Stabilization System; Risk Analysis; Risk Management; ISO14971; ADJACENT; LUMBAR;

D O I：

10.1007/978-3-319-12262-5_60

中图分类号：

R318 [生物医学工程];

学科分类号：

0831 ;

摘要：

A risk management report is an important part of the technical documentation of any medical device since it contains the risks and hazards linked to use and how the manufacturer handled them for the purposes of performance and safety. For devices sold in Europe, EN ISO 14971 provides methods and tools for manufacturers to analyze and manage the risks associated with their devices. This study analyzes a new dynamic spinal stabilization system based on ISO 14971 to optimize the performances and safety of the new design.

引用

页码：216 / 219

页数：4

共 8 条

[1]

[Anonymous], 2000, 14971 ISO

[2]

Barrey C, 2013, PEDICLE SCREW BASED

[3]

Ciarkowski A, 2006, MANAGEMENT MED DEVIC

[4] Correlation between sagittal plane changes and adjacent segment degeneration following lumbar spine fusion [J].

Kumar, MN ;

Baklanov, A ;

Chopin, D .

EUROPEAN SPINE JOURNAL, 2001, 10 (04) :314-319

[5]

Panjabi Manohar M, 1992, FUNCTION DYSFUNCTION, V5

[6] Lumbar motion segment pathology adjacent to thoracolumbar, lumbar, and lumbosacral fusions [J].

Schlegel, JD ;

Smith, JA ;

Schleusener, RL .

SPINE, 1996, 21 (08) :970-981

[7]

Welch W C, 2007, NEUROSURG FOCUS, V22

[8] Prospective Design Delineation and Subsequent In Vitro Evaluation of a New Posterior Dynamic Stabilization System [J].

Wilke, Hans-Joachim ;

Heuer, Frank ;

Schmidt, Hendrik .

SPINE, 2009, 34 (03) :255-261

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