Regulatory Requirements
Conformance Standards
The content of this instruction is fit for sterilizers.
Above sterilizer accord with the requirements of European Class B:
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 Milano
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 EN ISO 9001 and EN ISO 13485 certified.
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 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.
To Next Page
Loading...
