Medical device guidelines and regula...
Shanmugam, Prakash Srinivasan Timiri.

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  • Medical device guidelines and regulations handbook
  • 紀錄類型: 書目-電子資源 : Monograph/item
    正題名/作者: Medical device guidelines and regulations handbook/ edited by Prakash Srinivasan Timiri Shanmugam ... [et al.].
    其他作者: Shanmugam, Prakash Srinivasan Timiri.
    出版者: Cham :Springer International Publishing : : 2022.,
    面頁冊數: vi, 385 p. :ill. (some col.), digital ;24 cm.
    內容註: 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.
    Contained By: Springer Nature eBook
    標題: Medical instruments and apparatus. -
    電子資源: https://doi.org/10.1007/978-3-030-91855-2
    ISBN: 9783030918552
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