Practical introduction to IEC 61010-1
For regulatory and quality professionals
A brief summary of what the training is about. Lorem ipsum dolor sit amet consectetur adipiscing elit sociis eleifend augue interdum hendrerit natoque aenean, mauris cursus vitae nulla convallis dignissim pulvinar porttitor metus nullam magna non et.
Table Of Contents
Who the training is for
This practical training is for regulatory and quality professionals, regardless of their background, seeking an understanding of the IEC 61010 series of standards as they apply to in vitro diagnostic (IVD) medical equipment.
What the training covers
The training covers the basics of mains voltage, the history and operation of IEC 61010-1, important terminology and definitions, collateral and particular standards, normative references, component selection, and testing. Additionally, it draws parallels with the IEC 60601 series of standards as they apply to medical electrical equipment.
What you will do
The training is run as a workshop. There will be presentations, quizzes, round table discussions and, most importantly, testing – lots of testing. Testing will be undertaken according to the IEC 61010-1 test specifications, and has been selected to demonstrate areas of interpretative ambiguity and the physical and electrical brutality IVD medical equipment must withstand. The testing includes:
- Determination of ACCESSIBLE PARTS
- Marking and documentation
- Colour coding
- MAINS supply
- Plugs and connectors
- Sharp edges
- Handles and grips
- Impedance of PROTECTIVE BONDING of plug connected equipment
- ENCLOSURE rigidity – Static test
- ENCLOSURE rigidity – Impact test
- ENCLOSURE rigidity – Drop test
- Durability of markings
- Others, time permitting
Testing will be performed on custom IVD medical equipment phantoms, which have been designed and constructed to replicate a series of real-world test failures. A test passed by a phantom is great; a test failed is even better!
What you will take away
In addition to having fun and gaining new theoretical and practical knowledge, you will complete a test report for the phantoms which you can take away along with the other training materials for future reference.
Course Information
Delivery Method:
Duration:
Maximum Attendees:
Facilities Required (on-site):
- Tables and chairs
- Projector, with HDMI input
- Dry-wipe board or flipchart
- Table(s) for testing: wooden tops and legs, with a surface area of at least one square metre
- A BS 1363 socket with a TN supply at nominal UK mains voltage and frequency, with a residual current device (RCD) no less than 30 mA, and
without an arc-fault detection device (AFDD) - Access to the facilities for at least one hour before and after delivery
- Space to park a motorcar, within easy access of the facilities, to unload and reload
Test Equipment:
Test Consumables:
Safety Equipment:
Training Materials:
Certificates:
Cost:
Cost For Travel To Site:
Additional Information
Booking
To book a course, or to make an enquiry, please contact us.
Customisation
All training can be customised, subject to availability of appropriate test equipment where required.
Venue
The prices stated are based on the customer providing a suitable training facility. If you are not able to, a suitable facility can be arranged in Hook, Hampshire, at cost.
Upcoming Courses and Events
November/December 2024: Practical Introduction to IEC 60601-1 – For Quality and Regulatory Professionals. Hook, Hampshire. To be advertised on LinkedIn.
Equipment Sales and Hire
Any of the IEC standard test equipment used on any of the courses, from a test finger to a test corner, can be supplied – either for sale or hire. Please enquire.