Richard Wolf 2271 - General Requirements on Products;Components of a Combination

3
GA--A 181
1.3.2 General requirements on products/components of a combination
The general requirements depend on whether the products/components are in-
side or outside the patient environment.
Patient environment
R=1.5m
Patient environment
h=2.5m
Acc. to UL 60601--1: R = 1.83 m (6 feet) ; h = 2.29 m (7
1
/
2
feet)
Inside the patient environment
Non-- medically
used room
Medically used room
outside the patient
environment
Requirements / measures
Leakage currents to clause 19
IEC/EN 60601--1--1
*
MP
MP
MP
NMP
MP
NMP
MP
NMP
MP
MP or
NMP
µ
a) additional protective earth connection
(to be clarified with manufacturer),
or
b) with additional isolating transformer
**
a) common protective earth connection, or
b) additional protective earth connection
(to be clarified with manufacturer), or
c) additional separating device (to avoid
earth/ground loops in the case of a
potential difference)
MP NMP
--
--
--
--
--
--
**
--
additional separating device
according to IEC/ EN 60601--1--1
additional isolating transformer
according to IEC/ EN 60601--1--1 **
µ power supply grid
Functional
connection
µ
µ
µ
µ
µ
µ
µ
µ
µ
MP = medical electrical device according to IEC/ EN 60601--1, UL 60601--1, CSA C22.2 No. 601
NMP = non--medical electrical device in accordance with the relevant product--specific IEC/ EN/ UL/ IEC standards
* If connected via a joint mains/power cord under normal conditions the earth leakage current of the system must not exceed 500 µA
(300 µA for systems in acc.with UL 60601--1).
** e.g. Richard Wolf Video Trolley with ”isolating transformer”.