Did you know that…

• At the recent (August 2020) STAMP Workshop organized virtually by MIT was more than 2200 attendants worldwide;

• STAMP assumes that accidents can also be caused by unsafe interactions of system components, none of which may have failed;

• Amendment 2 of IEC 60601-1 and Collaterals (IEC 60601-1-2, IEC 60601-1-6, 60601-1-8, 60601-1-9, 60601-1-10, 60601-1-11, 60601-1-12) was published in July 2020;

• Due to the Amendment 2 of IEC 60601-1 and Collaterals may your equipment need to be re-tested and a new Test Report should be issued;

• At SC 62A, the IEC committee responsible for IEC60601-1 series of standards, was received few hundred requests for clarification of clauses from ed. 3.1 of the standard;

• The ed.3 of ISO 14971 Risk Management for Medical Devices standard, was published in December 2019;

• You can use a new document: ISO TR 24971 “Guidance on application of ISO 1497” published in June 2020;

• The standard IEC 62368 adopts fundamentally different engineering concepts and principles about the Product Safety;

• The IEEE-PSES (Product Safety Engineering Society) focuses on the theory, design, development and practical implementation of product safety engineering methodologies and techniques for equipment and devices.

• IEEE-PSES have a Mentorship Program for young and new Product Safety professionals.

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