Tuttnauer AMS10-120-T, Operation And Maintenance Manual

Page: 8 / 104

1. General Information
1.1 Manufacturer and US Official Correspondence
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 US Official Correspondence is:
+ Tuttnauer U.S.A. Co, Ltd. 25 Power Drive Hauppauge, NY, 11788, USA.
)
Tel (631) 737 4850, (800) 624 5836,
Ê
Fax: (631) 737 0720
1.2 Applicable Regulation and Quality Standards
The life cycle of Tuttnauer's T- Edge 10 is in compliance with the following
regulation and quality standards:
l
93/42/EEC, Council Directive, concerning medical devices
l
2014/68/EU, Directive, concerning pressure equipment.
l
2006/42/EC Machinery Directive.
l
2014/35/EU, Directive, Low Voltage Directive (LVD)
l
2014/30/EU, Electromagnetic compatibility.
l
2012/19/EU WEEE and EU Restriction of the use of certain hazardous
substances (RoHS Directive)
l
Canadian MDR (CMDR) SOR/98-282, consolidated.
l
ISO 9001Quality Management System.
l
EN ISO 13485 Quality Management System – Medical devices.
l
ISO 14001 environmental management system
l
EN ISO 14971 Medical devices – Application of risk management.
l
Chinese Regulations on Safety Technology for Pressure Vessel.
l
MEDDEV 2.12-1 Medical Devices Vigilance System
l
MEDDEV 2.12/2 Post Market Clinical Follow Up
l
MEDDEV 2.7.1 Rev 4 Clinical Evaluation
l
MEDDEV 2.5.2 Reporting of design changes of the quality system
l
ASME Code section I and section VIII. Div.I
l
ANSI/AAMI ST55 Tabletop steam sterilizers
l
IEC 61010- 1 Safety Requirements for electrical equipment for
measurement control and laboratory use.
l
EN 61010- 2- 40 Safety requirements for sterilizers and washer-
disinfectors used to treat medical materials.
Page 1