26 Specifications and Standards Compliance
205
Manufacturer's Information
You can write to Philips at this address:
Philips Medizin Systeme Boeblingen GmbH
Hewlett-Packard-Str. 2
71034 Boeblingen
Germany
Visit our website at: www.philips.com
© Copyright 2003 - 2011. Koninklijke Philips Electronics N.V. All Rights Reserved.
Trademark Acknowledgement
Oxisensor
TM
II, Oxi-Cliq
TM
, and OxiMax
TM
are trademarks of Tyco Healthcare Group LP, Nellcor
Puritan Bennett Division.
Regulatory and Standards Compliance
U.S. Federal Law restricts this device to sale by or on the order of a physician.
The monitor is in conformity with the requirements of the European Medical Devices Directive 93/
42/EEC and the following major international standards:
Safety and Performance
The monitor complies with the following major international safety and performance standards:
• EN 60601-1:1990+A1:1993+A2:1995/IEC 60601-1:1988+A1:1991+A2:1995
• EN 60601-1-1:2001/IEC 60601-1-1:2000
• EN 60601-1-6:2004/IEC 60601-1-6:2004
• EN/IEC 60601-2-27:2006
• EN/ISO 9919:2005
• EN 60601-2-30:2000/IEC 60601-2-30:1999
• EN/IEC 60601-2-37:2001+A1:2004
• EN 60601-2-49:2001/IEC 60601-2-49:2001
• UL 60601-1:2003
• CAN/CSA C22.2#601.1-M90
• JIS T 1303
• AS/NZS 3200.1.0-1998
The possibility of hazards arising from hardware and software errors was minimized in compliance
with ISO 14971:2000+A1:2003, EN60601-1-4:1996+A1:1999 and IEC 60601-1-4:1996+A1:1999.
Alarm sounds are compliant with the draft ISO/IEC 9703-2 Standard.
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