GE AED Pro - Safety and Performance Standards

Section 1: Introduction
2023486-201 Rev C © 2007 General Electric Company Page 9 of 53
SAFETY AND PERFORMANCE STANDARDS
AED PRO MODELS 2023440
The AED Pro has been designed and manufactured to conform to the highest standards of safety and performance
including electromagnetic compatibility (EMC). The Responder AED Pro Model 2023440 and pads conform to the
applicable requirements of the following:
CE
CE Marked by BSI 0086 per the Medical Device Directive 93/42/EEC of European Union
ETL
Classified by ETL Semko with respect to electric shock, fire and mechanical hazards only in
accordance with UL 60601-1, CAN/CSA C22.2 No.601.1-M90, EN60601-1 and EN60601-
2-4. Conforms to UL Standard UL60601-1. Certified to CAN/CSA Standard C22.2 No.
601.1-M90.
Electrical, Construction, Safety and Performance
IEC 60601-1 (1998), Amendments 1 (1991) & 2 (1995)
IEC 60601-2-4 (2002)
IEC 60601-1-4 (2000)
ANSI/AAMI DF-39 (1993)
Electromagnetic Compatibility (EMC)
IEC 60601-1-2 (2001)
IEC 60601-2-4 Section 36
ANSI/AAMI DF-39(1993) Section 3.3.21