CERTIFICATIONS

The HematoCare™ has completed its CE Marking approval. It meets the standards detailed below:

 

IEC 60601-1 APPROVAL

CB Scheme

– ANSI/AAMI ES 60601-1

– CAN/CSA-C22.2 No. 60601-1:08

IEC 60601-1-1, 3rd Ed. (2005)  Medical electrical equipment – Safety requirements for medical electrical systems- General safety rules

– EN 60601-1-1, 3rd Ed. (2006)

IEC 60601-1-2:2007, 3rd Ed. Medical electrical equipment – General requirements for basic safety and essential performance – Electromagnetic compatibility

– EN 60601-1-2:2007, corr 2011

 

CE MARKING

93/42/EEC  Medical Device Directive (MDD) – CE 0473 Certificate

97/23/EEC  Pressure Equipment Directive (PED) – Germanischer Lloyd Approval

 

 

ASME PVHO APPROVAL (Code Case  21)

ASME PVHO-1:2016  Safety Standard for Pressure Vessels for Human Occupancy