Medical Devices Standards Full Framework

Beside 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 bellow 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 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 magnete.)

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