Dental Delivery Unit Operation Manual
REV-A Page 3 of 43
Regulatory Requirements
Conformance Standards
The content of this instruction is fit for Dental Unit.
93/42/EEC
EN ISO 10993-1
EN ISO 7494-1
EN ISO 10993-5
EN ISO 7494-2
EN ISO 10993-10
EN 1640
EN 60601-1:1990+A1+A2+A13
EN 1639
EN 60601-1-1
ISO 9687
EN 60601-1-2
ISO 6875
EN 60601-1-4
ISO 9680
EN 60601-1-6
ISO 10637
EN 980
ISO 9168
EN 1041
DIN 13940-1
EN ISO 14971
EN ISO 17664
European Authorized Representative
DTF Technology s.r.l.
Address: via De Sanctis 32, 20141 Milan, Italy
Tel: 39 02 84893641
Fax: 39 02 84718594
This product complies with the regulatory requirement of the following:
Council Directive 93/42/EEC concerning medical devices:
The CE label affixed to the product testifies compliance to the Directive.
The location of the CE marking is shown in this manual.
Certifications
Manufactory is ISO 9001 and ISO 13485 certified.
Original Documentation
The original document is written in English.
Declaration of Conformity
Council Directive 93/42/EEC concerning medical devices:
The CE label affixed to the product testifies compliance to the Directive.
The location of the CE marking is shown in this manual. In this manual there are present the
CE certification and the Conformity. Check appendixes.
