000			02347cam a22004097a 4500
999			_c12357 _d12357
001			16023998
003			EG-NcFUE
005			20200224112218.0
008			091215s2010 au a 001 0 eng
010			_a 2009943512
015			_aGBA9A9624 _2bnb
016	7		_a015416043 _2Uk
020			_a9783211996829 (pbk.)
020			_a3211996826 (pbk.)
035			_a(OCoLC)ocn573059800
040			_aUKM _cUKM _dYDXCP _dIXA _dAHS _dLUI _dOHX _dDLC
042			_aukblcatcopy _alccopycat
050	0	0	_aR856.6 _b.L44 2010
082	0	0	_223 _a610.28 _bL.N.S
100	1		_aLeitgeb, N.
245	1	0	_aSafety of electromedical devices : _blaw, risk and opportunities / _cNorbert Leitgeb.
264			_aWien ; _aNew York : _bSpringer _cc2010.
300			_axi, 233 p. : _billustrations ; _c25 cm.
336			_2rdacontent _atext
337			_2rdamedia _aunmediated
338			_2rdacarrier _avolume
504			_aIncludes bibliographical references (p. [215]-219) and index.
505		0	_aMedical devices.- How safe is safe enough?.- Application safety.- Biocompatibility.- Hygiene.- Environmental safety.- Ecological safety.- Electric safety.- Electromedical devices.- Safety testing.
520			_aIn his new book, Norbert Leitgeb discusses the legal and technical requirements for manufacturers, designers and testers of electromedical devices. He 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. Leitgeb explains comprehensively 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, he describes which safety requirements are to be met and how they can be satisfied and tested. --Résumé de l'éditeur.
650		0	_aMedical instruments and apparatus _xSafety measures.
650		0	_aProducts liability _xMedical instruments and apparatus.
650		0	_aMedical instruments and apparatus _xDesign and construction _xStandards.
906			_a7 _bcbc _ccopycat _d2 _encip _f20 _gy-gencatlg
942			_2ddc _cBK