The IEC 60601 family of standards specifies the requirements for medical electrical equipment. The IEC 60601-1 is the most important standard in this family and defines the requirements for the basic safety and essential performance characteristics of medical devices.
What you will achieve by attending the IEC 60601-1 seminarThe two-day seminar gives you a solid understanding of the standard so that you
- develop safe and standard-compliant medical devices,
- pass admission without hassles and delays,
- Consolidate your competence and skills, close knowledge gaps and thus
- to develop safe products quickly and successfully.
After attending this seminar, you as a participant can
- Explain regulatory requirements of the standard and their applicability,
- reflect current changes (e.g. fourth edition, also of IEC 60601-1-2),
- understand the interaction of the IEC 60601 family of standards with each other and with other standards,
- Define terms and use them correctly (e.g. normal state, first error security, essential performance feature and basic security, MOOP, MOPP, PEMS, PESS),
- apply another method (functional safety) to systematically assess risks of architectural concepts,
- explain how the requirements of the Medical Devices Directive for integrated safety are met,
- Assign and evaluate protection concepts and measures to the hazard types,
- describe the interaction of the standard with risk management,
- Create isolation diagrams and
- Document in compliance with IEC 60601-1.
KONTAKT:
Online Seminar
