IEC 60601-1, 3rd ed. – How to Manage the Certification & Regulatory Risk. Upcoming Seminars
IEC 60601-1, 3rd ed. – How to Manage the Certification & Regulatory Risk
Seminar Details
Date: February 23rd, 2012
Location: NorthWest EMC Lab, 41 Tesla Avenue, Irvine, CA 92618
Registration: E-mail Katy Gillis (katy@gmcompliance.com) to reserve your seat.
Informational Seminar Hosted by: G&M Compliance , Inc., NorthWest EMC, Omnica Corporation, & Bentley Biomedical Consulting, LLC
Presented by: Dan Modi, NCE, CQA, RAC – on invitation by G&M Compliance;
And supported by the safety experts at G&M Compliance.
Registration
- Early Registration Discount By Feb. 1st: $799.00
- Regular Pricing Starting Feb. 2nd: $985.00
*Cost includes breakfast, lunch, snacks, and beverages.
E-mail Katy Gillis at katy@gmcompliance.com to reserve your seat.
Payment will be required to hold your reservation. An invoice will be emailed to you with payment instructions.
Agenda
- Breakfast: 8:30am
- Introductions & Morning *Session: 9:00am-12:00pm
- Lunch & Tour of Facility: 12:00pm-1:15pm
- Afternoon *Session: 1:15pm-4:30pm
*Each Session will include a 15 minute break and 30 minutes of Q&A.
We will also be doing a RAFFLE with a couple of drawings per session!
Topics To Be Covered:
- Regulatory Overview and Role of the IEC 60601-1 standard
- For various markets, effective Dates for 3rded. of 60601-1; And how to plan for compliance
- Overview / Structure of the IEC 60601-1
- Understanding the beast – Building blocks of the 3rd edition
- Review and impact of differences between the 2nd and 3rd ed.
- Essential Performance
- Insulation Coordination (What is this new requirement MOOP & MOPP)
- Leakage current and Applied Parts
- Temperature requirements
- Protection against Mechanical hazards
- Fire prevention
- Construction requirements
- Component requirements
- Clear understanding of new labeling requirements.
- 7 common pitfalls / misconceptions for compliance to 3rd ed.
- Impact of 3rd ed. on how 3rd party Test Laboratories will evaluate your product.
- How to adapt your Risk Management process to support IEC 60601-1
- Additional changes to expect with 3rd ed. of 60601-1 (the first amendment is coming soon)