GE AKTAprocess, Operating Instructions Manual

Page: 11 / 180

International standards
Harmonized standard requirements fulfilled by this product are summarized in the table
below.
Notes Description Standard
EN standard is
harmonized with
2006/95/EC Safety requirements for electrical
equipment for measurement, control, and
laboratory use EN 61010-1, IEC
61010-1, UL
61010-1,
CAN/CSA-C22.2
No. 61010-1
EN standard is
harmonized with
2004/108/EC EMC emissions and immunity
requirements for electrical equipment for
measurement, control and laboratory
use. Emission according to CISPR 11,
Group 1, class A EN 61326-1
EN ISO standard is
harmonized with
2006/42/EC Safety of machinery. General principles
for design. Risk assessment and risk
reduction. EN ISO 12100
Additional regulatory compliance
The table below lists additional regulatory requirements that are fulfilled by ÄKTAprocess.
Notes Description Requirement
Applicable for systems
with steel piping All steel piping welds, in-
cluding contact welds ASME-BPE
Applicable for polymeric
materials in contact with
process stream United States Pharma-
copia (USP)
Bio reactivity testing, In
Vivo USP <88> class VI
Applicable for polymeric
materials in contact with
process stream Code of Federal Regula-
tions, Food and Drugs Title
21, Part 177 FDA CFR 21 § 177 FDA
ÄKTAprocess Operating Instructions 29-0252-49 AA 11
1 Introduction
1.3 Regulatory information