MW8 & MotionWare User Guide: Issue 1.2.1
Page 74
C6 - Applicable
Standards:
The appropriate clauses of the following standards have been used as
a means of demonstrating compliance.
Standard
Description
EN60601-1:2006
Medical electrical equipment
– Part 1: General requirements for
basic safety and essential performance.
EN60601-1-2:2007
Medical electrical equipment
– Part 1-2: Collateral standard:
Electromagnetic compatibility
– Requirements and tests.
See Appendix C for declaration and guidance
EN60601-1-11:2010
Medical electrical equipment
– Part 1-11: Collateral standard:
Requirements for medical electrical equipment and medical
electrical systems used in the home healthcare environment.
EN60601-1-6:2010
Medical electrical equipment
– Part 1-11: Collateral standard:
Usability
EN62304:2006
Medical device software
– Software life-cycle processes
