Labomed PRIMA GN User Manual page 10

STANDARDS AND DIRECTIVES
The instrument described in this manual has been designed in compliance with the following
standards:
ISO 8600-3 First edition 1997-07-01 AMENDMENT 1 Optics and Optical instruments-Medical

endoscopes and endoscopic accessories Part 3: Determination of field of view and direction
of view of endoscopes with optics.
ISO 8600-3 First edition 1997-07-01 Optics and Optical instruments-Medical endoscopes

and endoscopic accessories Part 3: Determination of field of view and direction of view of
endoscopes with optics.
ISO 8600-5 First edition 2005-03-15 Optics and photonics-Medical endoscopes and

endotherapy devices- Part 5: Determination of optical resolution of rigid endoscopes with
optics.
ISO 9001/13485 quality management systems approved by UL (notified body).

ISO 14971-2007 Risk management to medical devices.

Directives used
Directives 93/42/EEC, Annex II, Article 3.

IEC 60601-1-3 edition (2005).

IEC 60601-1-2

EN 55011:2007

Classification
For Europe, per Directive 93/42/EEC, the unit is a Class I instrument

For USA: FDA classification Class II

Please observe all applicable accidental prevention regulations.

7
6165000-795
rd
PRIMA GN
Prima GN
Issue 1.4
Printed on March, 2016