TANDA Color Steam Sterilizer Operation Manual
Rev-C Page 2 of 17
Regulatory Requirement
Conformance Standard
The content of this manual is fit for the sterilizers.
Above sterilizer accords with the requirements of European Class N:
93/ 42/ EEC
97/ 23/ EC
EN 61010 -1
EN 61010 -2 -040
EN 13060
EN 61326 -1
European Authorized Representative
DTF Technology s.r.l.
Address: via Gressoney 9, 20137 Milan, Italy
Tel: 390284893641
Fax: 39 02 84718594
This equipment complies with the regulatory requirements 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.
Certification
Manufactory is certified with EN ISO 9001 and EN ISO 13485.
Original Documentation
The original document was written in English.
Declaration of Conformity
Council Directive 93/ 42/ EEC concerning medical devices:
The CE label affixed to the equipment 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.
