Ancar TOPCON ATE-800 사용 설명서 - 페이지 2
{카테고리_이름} Ancar TOPCON ATE-800에 대한 사용 설명서을 온라인으로 검색하거나 PDF를 다운로드하세요. Ancar TOPCON ATE-800 13 페이지. Ophthalmic table
페이지 인쇄EC Declaration of Conformity (Directive 93/42/EEC)
Manufacturer's Name
ANTONI CARLES, S.A.
With manufacturing and putting together of medical device license number 2509-PS granted by the Health
authorities of Spain
GMDN Code and Term
36255 - Examination / Treatment
Ophthalmic Table Line-powered
Device Class according to the intended use and the criteria of Annex IX of the Directive 93/42/EEC:
Scope of Application:
Power Supply:
Electrical Categorization: Type B
Each kind of medical device complies with the applicable provisions of the essential principles and the
classification rules before being supplied.
This Declaration is based on Certificates of Conformity issued by DNV Spain:
#0274-1999-AQ-BAR-ENAC according to ISO 9001:2000.
#0274-1999-NA-BAR-ENAC according to ISO 13485:2003.
We, the undersigned, under our sole responsibility, certify and declare that the medical devices specified
above are in conformity with the essential requirements, which are applicable to them, of RD 414/96,
transposition to the Spanish law of the directive 93/42/EEC. We also declare that we comply with the design
and construction requirements of the following standards:
Standards Applied:
UNE-EN 60601-1:1993 Medical electrical equipment. General requirements for safety
UNE-EN 60601-1-2:2002 Medical electrical equipment. General requirements for safety.
ISO 14971:2007 Medical Devices. Application of Risk Management to Medical Devices.
Authorized Signatory:
Josep Álvarez
Regulatory & Safety Officer
Antoni Carles, S.A.
Volta dels Garrofers, 41-42
Pol. Ind. Els Garrofers
08340-Vilassar de Mar
(Barcelona-SPAIN)
Class I
All
220-240 V ~ / 50-60 Hz
Electromagnetic Compatibility – Requirements and tests.
Antoni Carles Bosch
General Manager
T. (34) 93 754 07 97
F. (34) 93 759 26 04
www.ancar-online.com/
Type or
Model:
ATE-800
ANTONI CARLES, S.A.
C/Volta dels Garrofers, 41-42.
E-08340 VILASSAR DE MAR
2
ISO 9001
ISO13485
DCA-0274-AQ-99 DCA-0274-NA-99
Stamp, Date
Pol. Ind. "Els Garrofers
BARCELONA-SPAIN
March 23, 2009
QS4-423-01