Regulatory and Safety Specifications
xiv EarlyVue VS30 Instructions for Use
Medical Electrical Equipment
The EarlyVue VS30 vital signs monitor complies with the following standards:
• IEC 60601-2-49: 2011
• IEC 60601-1:2005+A1:2012
• IEC 60601-1-2: 2014
• IEC 60601-1-6:2010+A1:2013 (including IEC 62366: 2007 + A1: 2014)
• IEC 62304:2006+A1:2015
• IEC 60601-1-8: 2006/AMD1:2012
• IEC 60601-1-9: 2013
• IEC 80601-2-30:2009+A1:2013
• ISO 80601-2-55: 2011
• ISO 80601-2-56: 2017
• ISO 80601-2-61: 2011
Federal Information Processing Standards (FIPS)
If option F01 (U.S. Government package) is purchased and installed, the EarlyVue VS30
supports FIPS 140-2 compliance based on OpenSSL FIPS Object Module v2.0.5,
certificate #1747.