Titlebook: Medical Device Guidelines and Regulations Handbook; Prakash Srinivasan Timiri Shanmugam,Pugazhenthan T Book 2022 The Editor(s) (if applica

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https://doi.org/10.1007/978-3-030-91855-2Biomedical Micro Devices; Medical and Health Technologies; Medical device industry; Medical devices; Med

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978-3-030-91857-6The Editor(s) (if applicable) and The Author(s), under exclusive license to Springer Nature Switzerl

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ISO 14155: Clinical Investigation of Medical Devices for Human Subjects,the guidelines for preparing the CIPs. The title of the study and the reference number are considered the identity of a CIP. The important personnel (sponsor, coordinating investigator, and the principal clinical investigator) are responsible for approving the CIP. The CIP is also required to provid

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ISO 22442: Medical Devices Utilizing Animal Tissues and Their Derivatives,atives which are non-viable or rendered non-viable. This part of ISO 22442 is intended to cover medical devices including active implantable medical devices such as implantable infusion pumps. ISO 22442 consists of the following parts, under the general title Medical devices utilizing animal tissues

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,ISO 11135: Sterilization of Health-Care Products—Ethylene Oxide, Requirements for Development, Valiconcentration during the exposure should be constantly monitored. Packaging if any should not prevent EO penetration and at the same time should not modify the physical or chemical properties of the device being sterilized. As EO is toxic and flammable, care has to be taken for any residual EO on th