“More than just Digital”
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Doc. Name: PEDRA User’s Manual/Doc. No.: PEDRA-1417M-UM
Initiate date: 2020.07.25 /Revision date: 2020.10.15 (Rev. 1)
European Union
MDD (93/42/EEC)
Medical Device Directive
EN ISO 13485:2012+AC:2012
Medical devices –Quality Management systems –Requirements
for regulatory purposes
EN 60601-1: 2006
Medical electrical equipment-Part1: General requirements
for safety
IEC 60601-1-2: 2007(ed.3)
Medical electrical equipment-Part 1-2: Collateral standard:
Electromagnetic compatibility-Requirements and tests
IEC 62304:2006
Medical device software-Software life cycle processes
EN ISO 14971: 2012
Medical device –Application of risk management to medical
devices
