Medical device guidelines and regulations handbook / Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath, editors.
Shanmugam, Prakash Srinivasan Timiri, editor.; Thangaraju, Pugazhenthan, editor.; Palani, Nandakumar, editor.; Sampath, Thamizharasan, editor.
2022
R856
Available Online

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Title Medical device guidelines and regulations handbook / Prakash Srinivasan Timiri Shanmugam, Pugazhenthan Thangaraju, Nandakumar Palani, Thamizharasan Sampath, editors.
ISBN 9783030918552 (electronic bk.)
3030918556 (electronic bk.)
9783030918545 (print)
3030918548
DOI https://doi.org/10.1007/978-3-030-91855-2
Published Cham, Switzerland : Springer, 2022.
Language English
Description 1 online resource (vi, 385 pages) : illustrations (some color)
Item Number 10.1007/978-3-030-91855-2 doi
Call Number R856
Dewey Decimal Classification 610.28/4
Summary This 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.
Note Includes index.
Access Note Access limited to authorized users.
Source of Description Online resource; title from PDF title page (SpringerLink, viewed April 27, 2022).
Added Author Shanmugam, Prakash Srinivasan Timiri, editor.
Thangaraju, Pugazhenthan, editor.
Palani, Nandakumar, editor.
Sampath, Thamizharasan, editor.
Available in Other Form Print version: 9783030918545
Linked Resources Online Access
Record Appears in Online Resources > Ebooks
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Guidelines
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.

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