10
Prima ENT/DNT
STANDARDS AND DIRECTIVES
5
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 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, Article II, Section 5, Annex VII
·
IEC 60601-1-3rd edition (2005)
·
IEC 60601-1-2
·
EN 55011:2007
Classifications
·
For Europe, per Directive 93/42/EEC, the unit is a Class I instrument, per rule 12,
Annex IX.
·
For the United States, the FDA classification is Class I.
·
Please observe all applicable accident prevention regulations.
