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ISO 10993
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51	NOV[removed]k) Application; K130845 - Amnbu® aScope Tm 3 and Ambu® aViewM Monitor Add to Reading List Source URL: www.accessdata.fda.gov Language: English - Date: 2013-12-09 11:45:19 Health Ambu Ascope Medical device Federal Food Drug and Cosmetic Act Premarket approval Quality management system ISO 10993 Medicine Technology Food and Drug Administration
52	Guidance on legislation Clinical investigations of medical devices – biological safety assessment November 2013 Add to Reading List Source URL: www.mhra.gov.uk Language: English - Date: 2013-11-01 11:39:12 Risk management Safety engineering Medical equipment Clinical research ISO 10993 Medical device Risk assessment Medicines and Healthcare products Regulatory Agency Polyvinyl chloride Medicine Risk Technology
53	A Safer, Clearer, and Faster Course to Market Insights and Guidance for the Medical Technology Industry on the Role of Standards with Biocompatibility, Risk Management, and Sterility A Report on ... Add to Reading List Source URL: www.aami.org Language: English - Date: 2014-07-24 11:00:38 Medical device Medical equipment Medical technology ISO 10993 Center for Devices and Radiological Health Biocompatibility Association for the Advancement of Medical Instrumentation Unique Device Identification Medicine Health Food and Drug Administration
54	PDF Document Add to Reading List Source URL: management.360revolution.ro Language: English - Date: 2012-01-10 18:35:32 Toxicology Assay Biochemistry Titration Cytotoxicity ISO 10993 Staining Chemistry Immunology Laboratory techniques
55	Back Cover basic version - TZ to update as needed Add to Reading List Source URL: www.aami.org Language: English - Date: 2013-04-04 19:17:00 Medical technology Health Standards organizations American National Standards Institute Association for the Advancement of Medical Instrumentation IEC 60601 ISO 10993 Medical device Sterilization Medicine Technology Medical equipment
56	Attachment B CDRH Draft Guidance Cover Sheet Add to Reading List Source URL: www.fda.gov Language: English Medical equipment Medical device Medical technology Electrosurgery ISO 10993 Center for Devices and Radiological Health Biocompatibility Design controls Sterilization Medicine Food and Drug Administration Surgery
57	GUIDANCE FOR INDUSTRY AND FDA REVIEWERS Immunotoxicity Testing Guidance Document issued on: May 6, 1999 Add to Reading List Source URL: www.fda.gov Language: English Medical device Allergy Food and Drug Administration Autoimmunity Immune system Adverse effect Autoimmune disease ISO 10993 Immunogenicity Medicine Health Immunology
58	Guidance for FDA Reviewers Premarket Notification Submissions for Empty Containers for the Collection and Processing of Blood and Add to Reading List Source URL: www.fda.gov Language: English Technology Food law Pharmaceuticals policy Medical device Federal Food Drug and Cosmetic Act ISO 10993 Center for Devices and Radiological Health Biocompatibility Title 21 of the Code of Federal Regulations Medicine Health Food and Drug Administration
59	Guidance for Reviewers Premarket Notification Submissions for Blood and Plasma Warmers Add to Reading List Source URL: www.fda.gov Language: English Food law Pharmaceuticals policy Medical device Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Biocompatibility ISO 10993 Title 21 of the Code of Federal Regulations Regulatory requirement Medicine Health Food and Drug Administration
60	Guidance for FDA Reviewers Premarket Notification Submissions for Transfer Sets (Excluding Sterile Connecting Devices) Add to Reading List Source URL: www.fda.gov Language: English Pharmaceuticals policy Food law Medical equipment Medical device Medical technology Federal Food Drug and Cosmetic Act Center for Devices and Radiological Health Biocompatibility ISO 10993 Medicine Food and Drug Administration Health

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