6
1
General Information
Manufacturer and European Authorized Representative
Information
T-Edge 10 Autoclave is manufactured by Tuttnauer Ltd., Located Har
– Tuv B
Industrial Zone, P.O. Box 170, Beit Shemesh 9910101, Israel. Tel: +972-2-
9904611
The American Authorized Representative is:
Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA.
Tel (631) 737 4850, (800) 624 5836,
Fax: (631) 737 0720
Applicable Regulation
and
Quality Standards
The life cycle of Tuttnauer's T- Edge 10 is in compliance with the following
regulation and quality standards:
93/42/EEC, Council Directive, concerning medical devices
2014/68/EU, Directive, concerning pressure equipment.
2006/42/EC Machinery Directive.
2014/35/EU, Directive, Low Voltage Directive (LVD)
2014/30/EU, Electromagnetic compatibility.
2012/19/EU WEEE and EU (2017/2102 Restriction of the use of certain
hazardous substances (RoHS Directive)
Canadian MDR (CMDR) SOR/98-282 (2018), consolidated.
ISO 9001: 2015 Quality Management System.
EN ISO 13485:2016 Quality Management System
– Medical devices.
ISO 14001:2015 environmental management system
EN ISO 14971:2012 Medical devices
– Application of risk management.
Chinese Regulations on Safety Technology for Pressure Vessel.
MEDDEV 2.12-1 Rev 8 Medical Devices Vigilance System
MEDDEV 2.12/2 Rev 2 Post Market Clinical Follow Up
MEDDEV 2.7.1 Rev 4 Clinical Evaluation
MEDDEV 2.5.2 Rev 8 Reporting of design changes of the quality system
ASME Code section I and section VIII. Div.I
EN 13060:2014 Small steam sterilizer
