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الإطار الكامل لمعايير الأجهزة الطبية

. Medical Devices Standards Full Framework. ISO 13485

Besides the usual Medical devices global standards and norms:

  • ISO 13485: Medical devices — Quality management systems — Requirements for regulatory purposes
  • ISO 14971: Medical devices — Application of risk management to medical devices
  • IEC 60601: Medical electrical equipment — Part 1: General requirements for basic safety and essential performance

Find below an extensive list of applicable standards for most medical devices

(click on any intermediate node to extend the tree. Mouse-over on the standard's name to have its full title. Click on it to visit one of the suppliers)

Note: this tree is partially automatically generated and is intended for a first global approach. Do double-check the requirements and completeness (exemple of mistake: listing the rare earth metals standard for an MRI is not appropriate. An MRI has no real magnet.)

Refer to the standards official organisations listed in our tool directory.

المواضيع المغطاة: Medical Devices, Quality Management Systems, Risk Management, Medical Electrical Equipment, Safety Standards, Regulatory Compliance, ISO Standards, IEC Standards, Performance Standards, Clinical Evaluation, Usability Engineering, Biocompatibility, Design Control, Post-Market Surveillance, Validation and Verification, Software as a Medical Device, International Organization for Standardization, and International Electrotechnical Commission..

السياق التاريخي

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2013-09-24

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