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020			_a9783030918552
024	7		_a10.1007/978-3-030-91855-2 _2doi
040			_aTR-AnTOB _beng _erda _cTR-AnTOB
041			_aeng
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245	1	0	_aMedical Device Guidelines and Regulations Handbook _h[electronic resource] / _cedited by Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath.
250			_a1st ed. 2022.
264		1	_aCham : _bSpringer International Publishing : _bImprint: Springer, _c2022.
300			_a1 online resource
336			_atext _btxt _2rdacontent
337			_acomputer _bc _2rdamedia
338			_aonline resource _bcr _2rdacarrier
347			_atext file _bPDF _2rda
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.
650		0	_aBiomedical engineering.
650	1	4	_aBiomedical Engineering and Bioengineering.
650	2	4	_aBiomedical Devices and Instrumentation.
650	2	4	_aMedical and Health Technologies.
653		0	_aEquipment and Supplies -- standards
653		0	_aEquipment Design -- standards
653		0	_aMaterials Testing -- standards
700	1		_aTimiri Shanmugam, Prakash Srinivasan. _eeditor. _0(orcid)0000-0001-5927-3503 _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aThangaraju, Pugazhenthan. _eeditor. _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aPalani, Nandakumar. _eeditor. _4edt _4http://id.loc.gov/vocabulary/relators/edt
700	1		_aSampath, Thamizharasan. _eeditor. _4edt _4http://id.loc.gov/vocabulary/relators/edt
710	2		_aSpringerLink (Online service)
856	4	0	_uhttps://doi.org/10.1007/978-3-030-91855-2 _3Springer eBooks _zOnline access link to the resource
942			_2NLM _cEBK