User Manual
Table Of Contents
46
Questions? Call 1-800-635-6156
Technical Specifications
Standards Compliance
This device is designed to conform to the following Standards and Regulations:
• IEC/ANSI/ AAMI60601-1:2005/R(12)2012, SEFEJUJPO1BSUGeneral requirements for basic safety and
essentialperformance.’
• CSA C22.2 # 60601-1:2014 Ed.3 Medical Electrical Equipment - Part 1: General Requirements For Basic
Safety And Essential Performance
• IEC 60601-1-2, 3rd Edition (2007-03), General requirements for safety - Collateral
standard: Electromagnetic compatibility - Requirements and tests
• IEC 62366, 1st Edition (2015), ‘Medical devices – Application of usability engineering to
medical devices’
• IEC 60601-1-6, 3rd Edition (2013), ‘Collateral standard: Usability’
• IEC 60601-1-8, 2nd Edition (2006), ‘Collateral standard: General requirements, tests and
guidance for alarm systems in medical electrical equipment and medical electrical
systems’
• IEC 60601-1-11, 2nd Edition (2015) ‘Collateral standard: Requirements for medical electrical
equipment and medical electrical systems used in the home healthcare environment’
• ISO 10993-1 Biological evaluation of medical devices - Part 1: Evaluation and testing
(Biocompatibility)
• ISO 14971, 2nd Edition (2007), ‘Medical devices – Application of risk management to
medical devices’.
• &6$&1R6LJQDO(TXLSPHQW&DQDGD
• &)5)&&3DUW6XESDUW%6HFWLRQV
• &)5)&&3DUW6XESDUW&6HFWLRQ
• &)5)&&3DUW6XESDUW(
• 566/LFHQFH([HPSW5DGLR$SSDUDWXV&DWHJRU\,(TXLSPHQW
• 566'LJLWDO7UDQVPLVVLRQ6\VWHPV'76V)UHTXHQF\+RSSLQJ6\VWHPV)+6VDQG
/LFHQFH([HPSW/RFDO$UHD1HWZRUN/(/$1'HYLFHV
• 566*(1*HQHUDO5HTXLUHPHQWVIRU&RPSOLDQFHRI5DGLR$SSDUDWXV&DQDGD
• ,&(6,QIRUPDWLRQ7HFKQRORJ\(TXLSPHQW,QFOXGLQJ'LJLWDO$SSDUDWXV³/LPLWVDQG
0HWKRGVRI0HDVXUHPHQW&DQGD
•
draft
Confidential Draft for Agency Submission Only.
Not for Posting on any Public-Facing Website
Not for dissemination to the public without the express written consent of Philips.