15. STANDARDS AND DIRECTIVES
The instrument described in this user 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 endo-
scopes and endoscopic accessories Part 3: Determination of
field
of
vi
ew and direction of
view
of
endoscopes with optics.
• ISO 8600-5 First edition 2005-03-15 Optics and phonetics-Medical endoscopes and
endotherapy devices
Part 5: Determination of
field
of
view
and direction of
view
of endoscopes with optics.
• ISO 8600-5 First edition 2005-03-15 Optics and phonetics-Medical endoscopes and endotherapy
de
vi
ces
Part 5: Determination of optical resolution of rigid endoscopes with optics.
•
ISO 13485 quality management systems approved by UL.
• ISO 14971-2007 Risk management to medical de
vi
ces.
DIRECTIVE USED
•
MDR 2017/745 Annex IX And Rule 13
•
Directives 93/42/EEC, Article II, Section 5, Annex VIII.
• IEC 60601-1-3rd edition (2005)
• IEC 60601-1-2
• EN 55011:2007
CLASSIFICATIONS
•
For Europe, per MDR 2017/745, the unit is a Class I instrument, per rule 13,Annex IX.
• For the United States, t
he FDA classifica
tion is Class I.
• Please observe all applicable accident prevention regulations.
Prima
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Issue 1.9
Printed on Sept,2021
38