GE AKTAavant Getting Started page 11

International standards
This product fulfills the requirements of the following standards:
Standard
EN 61010-1, IEC
61010-1, UL 61010-1,
CAN/CSA-C22.2
No.61010-1
EN 61326-1
EN-ISO 12100-1,
12100-2
EN ISO 14121-1,
14121-2
Software declaration of
conformity
UNICORN 6 is technically compatible with all relevant sections of FDA 21 CFR Part 11.
A part 11-system assessment checklist is available on request through the local GEHC
representative.
Regulatory compliance of
connected equipment
Any equipment connected to the ÄKTAavant system should meet the safety requirements
of EN 61010-1/IEC 61010-1, or other relevant harmonized standards. Within EU,
connected equipment must be CE marked.
Getting Started with ÄKTAavant and UNICORN 6 28-9440-69 AB
Description
Safety requirements for electrical
equipment for measurement,
control, and laboratory use
EMC emissions and immunity
requirements for electrical
equipment for measurement,
control and laboratory use.
Safety of machinery — Basic
concepts, general principles for
design
Safety of machinery — Principles of
risk assessment
1 About this guide
1.2 Regulatory information
Notes
Harmonized with
2004/108/EC
CISPR 11 Group 1,
Class B
Harmonized with
2006/42/EC
Harmonized with
2006/42/EC
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