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008			221217s2022 sz | s |||| 0|eng d
020			_a9783030918552
024	7		_a10.1007/978-3-030-91855-2 _2doi
040			_aES-MaUEC _bspa _cES-MaUEC _dES-MaUEC
050		4	_aR856 _b2022 EB
245	0	0	_aMedical Device Guidelines and Regulations Handbook _cedited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath
250			_a1st edition 2022
264		1	_aCham _bSpringer International Publishing _c2022
300			_a1 recurso en línea (VI, 385 páginas) _b14 ilustraciones, 12 ilustraciones a color
336			_atexto _btxt _2rdacontent
337			_aelectrónico _bc _2rdamedia
338			_arecurso electrónico _bcr _2rdacarrier
347			_aarchivo de texto _bPDF
505	0		_aGuidelines -- ISO 10993 - Biological Evaluation of Medical Devices -- ISO 22442 - Medical Devices utilizing Animal Tissues and Their Derivatives -- ISO 14971 & 24971 - Medical Device Risk Management -- ISO 21534 - Non-Active Surgical Implants - Joint replacement implants -- ISO 16061 Instrumentation for Use in Association with Non-Active Surgical Implants -- ISO 13485 - Medical Devices - Quality Management Systems - Requirements for Regulatory Purposes -- ISO 19227- Implants for Surgery - Cleanliness of Orthopedic implants -- ISO 14155 - Clinical Investigation of Medical Devices for Human Subjects -- ISO 11607 - Packaging for Terminally Sterilized Medical Devices -- ISO 11137 -1, 2 and 3 - Sterilization of Health Care Products -- ISO 11135 - Sterilization of Health Care Products -Ethylene Oxide - Requirements for development, validation and routine control of a sterilization process for medical devices -- ISO 17665-1 - Sterilization of Health Care Products - Moist Heat -- Regulations -- FDA- CFR Title 21 - Food and Drugs: Parts 800 to 1299 -- Global Medical Device Regulations (covering various individual countries) -- EU 722/2012 - Animal Tissue Regulations in Effect for Some Medical Devices -- EU 2017/746 - In Vitro Diagnostic Medical Devices -- EU 1097/2006 - REACH.
520			_aThis comprehensive resource features in-depth discussions of important guidelines and regulations you will need to understand and properly meet medical device code-related requirements. Focusing on the practical application of the regulations, the Medical Device Guidelines and Regulations Handbook delivers clear explanations, real-world examples, and annotation on the applicable provisions that will allow you to safely and confidently choose materials and processes for medical device development, testing, and manufacturing. A critical resource for researchers and professionals in the medical device field; Thoroughly covers ISO 10993, ISO 22442, ISO 14971, ISO 13485, ISO 21534, REACH, RoHS, CLP, EU MDR; Presents simplified guidelines and regulation points.
988			_aSpringer_Engineering_2022
650		7	_2embne _9143820 _aIngeniería biomédica
650		7	_2embne _9405021 _aMedicina _xMaterial y equipo
650		7	_2embne _9150723 _aMateriales biomédicos
700	1		_aTimiri Shanmugam, Prakash Srinivasan _eeditor literario _0(orcid)0000-0001-5927-3503 _1https://orcid.org/0000-0001-5927-3503 _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aThangaraju, Pugazhenthan _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aPalani, Nandakumar _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aSampath, Thamizharasan _eeditor literario _4edt _4http://id.loc.gov/vocabulary/relators/edt
776	0	8	_iPrinted edition: _z9783030918545
776	0	8	_iPrinted edition: _z9783030918569
776	0	8	_iPrinted edition: _z9783030918576
856	4	0	_uhttps://go.openathens.net/redirector/universidadeuropea.es?url=https://doi.org/10.1007/978-3-030-91855-2 _zAcceso a este recurso digital (usuarios Universidad Europea de Madrid)
942			_2lcc _cLE
998			_b12/2022 _dz _eIG _zSI