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DAIHAN Scientific, Steam Sterilizers Digital Fuzzy-controlled Autoclaves .
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European Declaration of Conformity
We, DAIHAN Scientific Co., Ltd.,
Daihan Bldg., 24-4, Sangwolgok-dong, Seongbuk-gu, Seoul, Korea,
Tel: 82-2-967-5235, Fax: 82-2-963-5231
declare that in compliance with the above Directive, that the product(s)
detailed below have been manufactured in accordance with conformity assessment
module A1, “Internal product control with monitoring of final assessment”. (Category II)
Autoclave
1.
Item: Vessel of Autoclave
2.
Model names: MaXterile 47, MaXterile 60, MaXterile 80
3.
Design Pressure: 2.5bar
4.
Operation Pressure: 1.2~2 bar
5.
Design Temperature: 140
℃
6.
Operation Temperature: 121 ~ 132
℃
7.
Hydrostatic Test Pressure: 3.6bar
Applicable Standards/provisions: EN ISO 13485:2003 and the provisions in Annex II of the EC-Directive
93/42/EEC, with the exemption of section 4
Signed: ____________________________ (Eun Taek Shu)
Date: 27, March 2015
Authority: President / CEO
For
DAIHAN Scientific Co., Ltd.,
Daihan Bldg., 24-4, Sangwolgok-dong, Seongbuk-gu, Seoul, Korea.
Tel: 82-2-967-5235, Fax: 82-2-963-5231
DH-DC08005-R03
