IEC 60601-1 Third Edition was released in late 2005. It is a new philosophy in standards for medical electrical devices to accommodate rapid advances in technology.
This new philosophy has been difficult for test houses and compliance bodies to absorb and develop test strategies. Currently, the EU and Canada have announced May 31-June 1, 2012 as the date when the Second Edition will be withdrawn. Devices that will be released after that date must meet the requirements of the Third Edition. Manufacturers with products under development must start now to develop compliance strategies. The first step will be understanding the requirements of the new standard.
Areas Covered in the Session: - ISO 14971 compliance is a requirement of IEC 60601-1
- The new standard uses risk management throughout
- The new standard is less prescriptive in many areas
- The new standard requires that all applicable collateral and particular standards must be used for compliance
- Current activities leading to full implementation of the standard
- Available documents to guide implementation of the Third Edition
Who Will Benefit: - Design Engineers
- Quality Engineers and Managers
- Compliance Engineers
- Engineering Managers
- Project Managers
- Verification and Validation Engineers and Mangers
