000			02136nam a22003975i 4500
001			u373099
003			SIRSI
005			20160812084130.0
007			cr nn 008mamaa
008			100505s2010 au | s |||| 0|eng d
020			_a9783211996836 _9978-3-211-99683-6
040			_cMX-MeUAM
050		4	_aR856-857
082	0	4	_a610.28 _223
100	1		_aLeitgeb, Norbert. _eauthor.
245	1	0	_aSafety of Electromedical Devices _h[recurso electrónico] : _bLaw — Risks — Opportunities / _cby Norbert Leitgeb.
264		1	_aVienna : _bSpringer Vienna, _c2010.
300			_aXI, 233 p. _bonline resource.
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
505	0		_aMedical devices -- How safe is safe enough? -- Application safety -- Biocompatibility -- Hygiene -- Environmental safety -- Ecological safety -- Electric safety -- Electromedical devices -- Safety testing.
520			_aThe book discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. It describes which obstacles must be overcome to introduce a medical device on the European market, but also informs readers as to pitfalls and opportunities, and in which way safety can be achieved and product liability limited. It explains how the newly required risk management process, which comprises risk analysis, risk assessment, risk management and risk control, can be implemented. As a final essential consideration, the book describes which safety requirements are to be met and how they can be satisfied and tested.
650		0	_aEngineering.
650		0	_aBiomedical engineering.
650	1	4	_aEngineering.
650	2	4	_aBiomedical Engineering.
710	2		_aSpringerLink (Online service)
773	0		_tSpringer eBooks
776	0	8	_iPrinted edition: _z9783211996829
856	4	0	_zLibro electrónico _uhttp://148.231.10.114:2048/login?url=http://link.springer.com/book/10.1007/978-3-211-99683-6
596			_a19
942			_cLIBRO_ELEC
999			_c200979 _d200979