Get up to speed on the latest and developing requirements for the electro-medical collateral standards for the home healthcare environment (HHE) IEC 60601-1-11:2010 and the proposed IEC 60601-1-12 standard for the emergency medical environment (EMS). These two collateral standards are an extension of IEC 60601-1:2005, the general standard. Is your company ready for the implications of these standards as you will have regulatory requirements for the HHE standard come up soon (depending on the country of concern) and it will be similar once the EMS standard is published.

In this audio conference, Leo Eisner guides you through IEC 60601-1-11:2010 with new definitions, additions and changes to the general standard. The presentation reviews the significant issues including earthing requirements and additional mechanical and environmental tests. It also compares the requirements of each standard to provide a perspective on what the EMS may look like vs. the HHE standard.

Ease your development stress for HHE and EMS devices with detailed guidance from a leading expert!

This audio conference covers:

• What are the grounding requirements for Home Healthcare Equipment standard?
• Additional mechanical tests for both standards
• Additional environmental tests for both standards
• Applied part requirements for the Home Healthcare standard
• Differences between the two standards

About the speaker:

Leo Eisner leads Eisner Safety Consultants in its efforts to help medical device, IVD and high-tech device clients navigate international product safety. Leo specializes in medical device quality systems & auditing; regulatory processes such as FDA 510(k)s, IDEs, & PMAs, CE marking and the Canadian Medical Device Regulations; risk management; and development of international product safety standards. As a registered Professional Engineer in the Safety Engineering discipline, he has over 25 years experience in product safety. In his nine years with UL, he worked with a variety of product categories and then spent several years with TÜV Product Service, specializing in electrical medical products. He later joined Karl Storz Imaging as a Compliance Engineer and has been consulting independently for over 10 years.

Leo is a member of RAPS, AAMI, ASQ and IEEE and has co-authored numerous articles on IEC 60601-1 and medical device safety. He is the convener of IEC SC 62D JWG9 (IEC/ISO 80601-2-58) and is a member of several IEC 62 technical advisory groups for the IEC 60601 series of standards.

Who should attend?

• Compliance and Product Safety Engineers
• Regulatory Affairs/Quality Assurance
• R&D and Quality Engineers
• Quality and Manufacturing Engineers
• Operations/Manufacturing Management
• Engineering Management