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Relevant International Industry Standards

Disclaimer: The standards below are informative and for educational purposes only. BEAA does not take any consequential responsibility whatsoever resulting from partially or fully adopting these standards or their misuse.biomedical engineering 

ISO 9001:2015 (general quality management system)

ISO 13485:2016 (quality management system for medical devices)

ISO/IEC 27001 (information security management)

IEC 60601 (product safety standards for medical devices)

ISO 14971:2019 (application of risk management to medical devices)

ISO/TS 10974:2018 (Assessment of the safety of magnetic resonance imaging for patients with an active implantable medical devices)

ISO 10993-1:2018 (Biological evaluation of medical devices-Part 1: Evaluation and testing within a risk management process)

GDPR (General Data Protection Regulation)

ICNIRP Guidelines for Limiting Exposure to Electromagnetic Fields (100kHz to 300 GHz)

MDCG 2019-11: Guidance on Qualification and Classification of Software in Regulation (EU) 2017/745 - MDR and Regulation (EU) 2017/746 - IVDR

Is Your Software a Medical Device? (by the European Commission, Directorate-General for Health and Food Safety)

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