Keystone Compliance, a regulatory compliance test lab headquartered in New Castle, Pa., will host a free seminar covering the increased compliance requirements of IEC 60601-1 Third Edition. The seminar will be held on Thursday, March 8, 2012 at the company’s new laboratory. The guest speaker will be Carlos Gutierrez of G&M Compliance. Topics to be discussed include:
- Implementation Dates for EN6061-1:2006 (3rd ed) and AAMI ES 60601-1:2005
o There are different dates that apply for Europe, Canada and the US
o The impact the staggered dates may have on test protocols
- New terminology and concepts introduced as part of the Third Edition standard and how these affect the evaluation/certification process
o The concept of “Essential Performance”
o ISO 14971 – Medical devices — Application of Risk Management to Medical Devices
- How to prepare for evaluation and certification o Gap Analysis
o Use of Second Edition reports to substantiate compliance to Third Edition
o New Submittals
Seminar details are as follows:
Location: Keystone Compliance
131 North Columbus Interbelt,
New Castle, PA 16101
Cost: Free
Agenda: 8:30 AM –9:00 AM: Registration and Continental Breakfast
9:00 AM –9:20 AM: Introductions
9:20 AM –11:15 AM: Presentation
11:15 AM –11:45 AM: Question and Answer
11:45 AM –12:00 PM: Lab Tour
To Register: Visit www.keystonecompliance.com or call (724) 657-9940
About Keystone Compliance
Keystone Compliance is a regulatory compliance testing laboratory that assists manufacturers with regulatory compliance from a product’s concept to its introduction to the market. The lab is conveniently located between Pittsburgh and Cleveland in New Castle, PA. The Company specializes in assisting manufacturers and engineers in meeting worldwide regulatory compliance in the areas of EMC, EMI, environmental and product safety testing. Keystone Compliance’s EMC/EMI lab includes two anechoic/ferrite lined three-meter test chambers as well as three other semi-anechoic chambers. The environmental lab includes two electrodynamic shakers, two walk-in temperature/humidity chambers, a number of reach-in temperature/humidity chambers and a variety of other environmental test equipment.





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