Technical Specifications - Anspach eG1 High Speed System Mode D'emploi

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  • FRANÇAIS, page 63

Technical Specifications

The device complies with the following standards:
IEC 60601-1:2005: + CORR. 1 (2006) + CORR. 2 (2007), EN 60601-1:2006 +A11:2011, ANSI/AAMI ES60601-
1:2005, CAN/CSA-C22.2 No.60601-1:08, (3rd edition) Medical electrical part 1: General requirements for basic
safety and essential performance;
UL 60601-1:2003 (Revised 2006), IEC 601-1:1988 +A1:1991 + A2:1995; EN60601-1:1990 with A1 and
A12:1993, A2:1995 and A13:1996; and CAN/CSA C22.2 No. 601.1-M90, Standard for Medical Electrical
Equipment – Part 1 General Requirements for Safety
With regard to electrical shock, fire, mechanical hazards, this ETL classified device conforms to AAMI STD
ES60601-1, UL STD 60601-1, and is certified to CSA STD C22.2 No.60601-1 and 601.1
This device complies with applicable EEC directives. Medical Device Directive 93/42/EEC as amended by
2007/47/EC. Machinery Directive 2006/46/EC.
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