ISO 14971 for IEC 60601-1
For regulatory and quality professionals
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Table Of Contents
Who the training is for
This training is for regulatory and quality professionals, regardless of their background, seeking an understanding of the relationship between ISO 14971 and the IEC 60601 series of standards.
What the training covers
The training will cover the risk management requirements for the following clauses of IEC 60601-1:
- Clause 4 – General requirements
- Clause 5 – General requirements for testing ME EQUIPMENT
- Clause 7 – ME EQUIPMENT identification, marking and documents
- Clause 8 – Protection against electrical HAZARDS from ME EQUIPMENT
- Clause 9 – Protection against MECHANICAL HAZARDS of ME EQUIPMENT and ME SYSTEMS
- Clause 10 – Protection against unwanted and excessive radiation HAZARDS
- Clause 11 – Protection against excessive temperatures and other HAZARD
- Clause 12 – Accuracy of controls and instruments and protection against hazardous outputs
- Clause 13 – HAZARDOUS SITUATIONS and fault conditions for ME EQUIPMENT
- Clause 14 – PROGRAMMABLE ELECTRICAL MEDICAL SYSTEMS (PEMS)
- Clause 15 – Construction of ME EQUIPMENT
- Clause 16 – ME SYSTEMS
- Clause 17 – Electromagnetic compatibility of ME EQUIPMENT and ME SYSTEMS
It will cite real-world examples – taken from field safety corrective actions (FSCAs), recalls, and national safety publications – where manufacturers have failed to comply with the requirements of ISO 14971 as they apply to the IEC 60601 series of standards.
What you will do
If the training is delivered on-site, there will be individual and group activities focussed on examining and discussing particular risk control measures – or the lack thereof. You will also get to inspect and test perhaps one of the most hazardous pieces of medical electrical equipment of recent times.
What you will take away
In addition to having fun and gaining new theoretical (and practical) knowledge, you will receive training materials which you can take away 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
- 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
Facilities Required (online):
- Computer, with internet access
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.