Quality Training

Integrating IEC 60601 into the Design Process

Objectives

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

Delivered over 5 x half day virtual sessions from 9:00 - 13:15 each day.

Presentation slides contain excerpts from the applicable safety standards, and frequent examples to illustrate how the safety requirements apply to typical medical device designs. Participants are broken into work groups where they put newly learned safety requirements into practice with assigned exercises. Each participant will receive a work book and after the class, the work book with answers is shared to embed learning's.

Our expert trainer continues to evolve the course to stay up to date with latest standards, interpretations, regulatory guidance, and feedback from over 1,600 past participants on his training programmes. Participants are encouraged to ask questions about the safety requirements, and how they apply to their products currently under development.

The goals of the course are:

• Identify applicable standards,
• Practical application of requirements to typical medical device designs,
• Applying new concepts in small group break out sessions,
• Supporting regulatory requirements,
• Integrating risk management, usability engineering, and test requirements into the design process,
• Constructing insulation diagrams,
• Identifying safety critical components and requirements, and
• Documenting compliance to IEC 60601-1 using IECEE CB formatted test report forms.

Content includes

The course content includes an overview of these product standards:

• 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 + A2:2020, ed 2.2
• Home Healthcare, IEC 60601-1-11:2015 + A1:2020, ed 2.1
• Emergency Medical Services, IEC 60601-1-12:2016 + A1:2020, ed 1.1
• How to document applicable "Risk Management Results" in IEC 60601 test reports, IECEE CB-OD 2044:2013, ed 2.2 and these process standards, which IEC 60601 requires and relies on:
• Risk Management, ISO 14971:2019, ed 3.0
• Usability Engineering, IEC 62366-1:2015 + A1:2020, ed 1.1, and IEC 60601-1-6:2006 + A1:2013 + A2:2020, ed 3.2
• Software development life cycle, IEC 62304:2006 + A1:2015 , ed 1.1

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: