Quality Training

Integrating IEC 60601 into the Design Process

Objectives

This 2 day training programme will give participants in depth knowledge on integrating the medical electrical equipment safety standard series, IEC 60601, into the design process.

Presentation slides will contain excerpts from the applicable safety standards, and frequent examples to illustrate how the safety requirements apply to typical medical device designs, and pitfalls to avoid. Participants are encouraged to ask questions about the safety requirements, and how they apply to their products currently under development.

Content includes

Safety standards covered:

• Medical Electrical Equipment -- Basic safety and Essential performance (general), IEC 60601-1:2005 + C1:2006 + C2:2007 + A1:2012 + A1-C1:2014 + A2:2019 (draft), Ed 3.1 and 3.2 (draft), including the US, Can, and EU differences
• Alarms, IEC 60601-1-8:2006 + A1:2012 + A2:2017/CD (draft)
• Home healthcare, IEC 60601-1-11:2015
• Emergency medical services (pre-hospital), IEC 60601-1-12:2014

Who should attend

The course is geared towards Technical design engineers, Compliance engineers, Regulatory/quality system specialists, Any staff responsible for medical device safety. There are no course prerequisites, although some familiarity with quality management and risk management procedures is helpful.

Upcoming dates:

No training dates available at the moment.