Download Medical electrical equipment

VICTRONIC TECHNOLOGY CORPORATION
IEC 60601-1
Clause
7.9.3.2
Requirement + Test
Result - Remark
Verdict
MANUFACTURER’S optional requirements for
minimum qualifications of SERVICE PERSONNEL
documented in technical description
N/A
The technical description contains the following required information
N/A
–type and full rating of fuses used in SUPPLY
MAINS external to PERMANENTLY INSTALLED ME
EQUIPMENT, when type and rating of fuses are
not apparent from information on RATED current
and mode of operation of ME EQUIPMENT .......... :
Not permanently installed
ME equipment
N/A
– a statement for ME EQUIPMENT with a nonDETACHABLE POWER SUPPLY CORD if POWER SUPPLY
CORD is replaceable by SERVICE PERSONNEL, and
Detachable power supply
cord used.
N/A
No such instruction is
required
N/A
if so, instructions for correct connection and
anchoring to ensure compliance with 8.11.3
– instructions for correct replacement of
interchangeable or detachable parts specified
by MANUFACTURER as replaceable by SERVICE
PERSONNEL, and
– warnings identifying nature of HAZARD when
replacement of a component could result in an
unacceptable RISK, and when replaceable by
SERVICE PERSONNEL all information necessary to
safely replace the component
N/A
7.9.3.3
Technical description indicates, MANUFACTURER See User Manual: “Safety &
will provide circuit diagrams, component part
Warranty”
lists, descriptions, calibration instructions to
assist to SERVICE PERSONNEL in parts repair
Pass
7.9.3.4
Means used to comply with requirements of
Isolation power supply
8.11.1 clearly identified in technical description provided as source of
electricity
Pass
8
PROTECTION AGAINST ELECTRICAL HAZARDS FROM ME EQUIPMENT
Pass
8.1
Limits specified in Clause 8.4 not exceeded for See appended RM Results
ACCESSIBLE PARTS and APPLIED PARTS in NORMAL
Table 8.1 b(1), 8.1 b(2) and
or SINGLE FAULT CONDITIONS
8.1 b(3)
Pass
NORMAL CONDITION considered as simultaneous
occurrence of situations identified in 8.1a)
Pass
SINGLE FAULT CONDITION considered to include
See appended RM Results
the occurrences as specified in Clause 8.1b) ... : Table 8.1 b(1), 8.1 b(2) and
8.1 b(3)
Pass
ACCESSIBLE PARTS determined according to 5.9
Pass
LEAKAGE CURRENTS measured according to 8.7
Pass
Requirements related to power sources
Pass
8.2
Test Report No.: 1403042002
60601-1TRF_A
Page 30 of 197
Issued: 25 July, 2014