10PB
E352266
51 DePuy Synthes User Manual Small Battery Drive II
The device meets the following standards
Medical electrical equipment – Part 1:
General requirements for basic safety and essential
performance:
IEC 60601-1 (2012) (Ed. 3.1),
EN 60601-1 (2006) + A11 + A1 + A12,
ANSI/AAMI ES60601-1:2005/(R)2012,
CAN/CSA-C22.2 NO. 60601–1: 14
Medical electrical equipment – Part 1–2:
Collateral Standard: Electromagnetic disturbances –
Requirements and tests:
IEC 60601-1-2 (2014) (Ed. 4.0),
EN 60601-1-2 (2015)
Medical electrical equipment – Part 1–6:
Collateral Standard: Usability:
IEC 60601-1-6 (2010) (Ed. 3.0) + A1 (2013)
System Specifications
Applicable Standards
Medical General medical equipment as to electrical shock,
fire and mechanical hazards only in accordance with:
ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012)
CAN/CSA-C22.2 No. 60601-1 (2014)
Summary of Contents for DePuy Synthes Small Battery Drive II
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