Transcription of Medical Device Regulations and Utilization of ...
{{id}} {{{paragraph}}}
Example: stock market
Medical Device Regulations and Utilization of ...
Medical Device Regulations and Utilization of International Standardsin JapanKatsuhisa IdeDiv. of Standard for Medical DevicesOffice of Standards and Guidelines DevelopmentPharmaceuticals and Medical Devices Agency1 Agenda Overview of Risk-based Medical Device Regulations in Japan Process of Developing Standards in Japan Utilization of Standards Agenda Overview of Risk-based Medical Device Regulations in Japan Process of Developing Standards in Japan Utilization of Standards GHTF ClassificationClass Aextremely low riskX-Ray filmClassBlow riskMRI, digestive cathetersClassCmedium riskartificial bones, dialyzerClassDhigh riskpacemaker, artificial heart valvesRegulations on Medical Device , based on risk 4 Medical Device Category in JapanClass IGeneral MDsX-Ray filmClass IIControlled MDsMRI, digestive cathetersClass IIIS pecially Controlled MDsartificial bones.
Clause 1 Medical devices should be designed and ... JIS Z 4751-2-54:2012 is based on IEC 60601-2-54:2009 (MOD) 14 Example of Certification Standard Essential Principles Checklist. ... ISO/TC 194 Biological and clinical evaluation of medical devices IEC/TC 62 Electrical equipment in medical practice ISO/TC 215 Health informatics
Tags:
Information
Domain:
Source:
Link to this page:
Please notify us if you found a problem with this document: