ADLINK Medical-i7 18/21 - Manual (Page 49)

PENTA Medical i5/i7
Manual
Rev. 1.5
Document: Manual_Medical_i7_R1.5.docx Page 49 of 59 pages Last change date: 7-Mar-13
11. C
ERTIFICATIONS AND
N
ORMS
11.1. Medical Directive
The PENTA Medical i5/i7 has been proofed based on the
Medical Directive 93/42/EEC + 2007/47/EC.
It has been tested according
EN IEC 60601-1-2:2007
for EMC and
IEC60601-1:2005+ Corr.1 (2006) + Corr. 2 (2007) (3 rd edition)
for safety.
11.2. IP65 preparation
The unit is prepared to full fill (with appropriate cable cover) the IP65 compliance, whereby it has
not
been tested and proofed by a laboratory.
IP6x compliance according to EN 60529 (dust intrusion)
to be tested
IPx5 compliance according to EN 60529 (splash water intrusion) to be tested